Clinical Trials

Lymphomas / Myelomas / Leukemias

Recruitment stopped
Ongoing Recruitment

Multiple Myeloma (Plasmocytoma)

BIRMA (CLGX818ADE01T)

(second-line)
Title:LGX818 in Combination With MEK162 in Refractory or Relapsed Multiple Myeloma Patients With BRAFV600E or BRAFV600K Mutation
Indication:Multiple Myeloma, Neoplasms, Plasma Cell
Type of study:Phase II
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02834364
EudraCT: 2014-004597-42 (siehe EU klinisches Studienregister)

GMMG-DANTE

(second-line)
Title:Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment Including Subjects Undergoing Hemodialysis: A Phase 2, Open-label, Multicenter Trial
Indication:Multiple Myeloma, Neoplasms, Plasma Cell, Renal Insufficiency
Type of study:Phase II
Contact: Dr. Marc Raab (Kontaktperson)
[marc.raab@med.uni-heidelberg.de]
Investigator: Prof. Dr. Hartmut Goldschmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02977494
EudraCT: 2016-000433-51 (siehe EU klinisches Studienregister)

MP0250-CP201 / MP-Studie

(second-line)
Title:A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma
Indication:Multiple Myeloma, Neoplasms, Plasma Cell
Type of study:Phase II
Contact: Dr. Marc Raab (Kontaktperson)
[marc.raab@med.uni-heidelberg.de]
Investigator: Prof. Dr. Hartmut Goldschmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03136653
EudraCT: 2016-002771-10 (siehe EU klinisches Studienregister)

OPTIMISMM (CC-4047-MM-007)

(second-line)
Title:A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Indication:Multiple Myeloma Neoplasms, Plasma Cell
Type of study:Phase III
Contact: Dr. Marc Raab (Kontaktperson)
[marc.raab@med.uni-heidelberg.de]
Investigator: Prof. Dr. Hartmut Goldschmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01734928
EudraCT: 2014-000268-17 (siehe EU klinisches Studienregister)

Transregio-79

(diagnostisch, Screening)
Title:Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging
Indication:Multiple Myeloma, Spinal Fractures Osteoporosis
Type of study:Phase N/A
Contact: Radiologie DKFZ (Kontaktperson)
[-]
Investigator: Prof. Dr. Stefan Delorme (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01374412
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Verfettungsstudie

(diagnostisch, Screening)
Title:Durch Strahlentherapie induzierte Verfettung des Knochenmarks in der diffusionsgewichteten MRT (DWI).
Indication:n.a.
Type of study:Phase N/A
Contact: Prof. Dr. Stefan Delorme (Kontaktperson)
[s.delorme@dkfz-heidelberg.de]
Investigator: Prof. Dr. Stefan Delorme (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PREAMBLE

(epidemiologisch)
Title:Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Indication:Multiple Myeloma Neoplasms, Plasma Cell
Type of study:Phase IV
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01838512
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

BO 39813

Title:A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma
Indication:Multiple MyelomaNeoplasms, Plasma Cell
Type of study:Phase I/II
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03312530
EudraCT: 2017-000830-68 (siehe EU klinisches Studienregister)

GMI-1271-230

Title:A Phase I Open-Label Dose Escalation Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care Chemotherapy for the Treatment of Multiple Myeloma
Indication:Multiple MyelomaNeoplasms, Plasma Cell
Type of study:Phase I
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02811822
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

GMMG-CONCEPT

Title:Clinical Phase II, Multicenter, Open-label Study Evaluating iNduction, Consolidation and Maintenance With Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary Diagnosed High-risk Multiple Myeloma paTients
Indication:Multiple MyelomaNeoplasms, Plasma Cell
Type of study:Phase II
Contact: Raphael Lutz (Kontaktperson)
[raphael.lutz@med.uni-heidelberg.de]
Investigator: Prof. Dr. Hartmut Goldschmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03104842
EudraCT: 2016-000432-17 (siehe EU klinisches Studienregister)

MIK-Studie (CMIK665X2101)

Title:Phase I Open Label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacokinetics of Intravenously Administered MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
Indication:LymphomaMultiple MyelomaNeoplasms, Plasma CellLymphoma, Large B-Cell, Diffuse
Type of study:Phase I
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02992483
EudraCT: 2016-003624-22 (siehe EU klinisches Studienregister)

NSMM-5001 / INSIGHT MM

Title:A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT-MM Study
Indication:Multiple Myeloma, Neoplasms, Plasma Cell
Type of study:Phase IV
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Prof. Dr. Hartmut Goldschmidt (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02761187
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PDR-Studie (CPDR001X2106)

Title:Phase I/Ib, Multi-center, Open-label, Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Relapsed and/or Refractory Multiple Myeloma
Indication:Multiple MyelomaNeoplasms, Plasma Cell
Type of study:Phase I
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03111992
EudraCT: 2016-005130-30 (siehe EU klinisches Studienregister)

STORM (KCP-330-012)

Title:A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low--Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab
Indication:Multiple MyelomaNeoplasms, Plasma Cell
Type of study:Phase II
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Dr. Marc Raab (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02336815
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Leukemias

BRF117019

(adjuvant)
Title:A Phase II, Open-label, Study in Subjects with BRAF V600EMutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib
Indication:Anaplastic Thyroid Cancer; Biliary Tract Cancer; Gastrointestinal Cancer; Germ Cell Tumors; Brain Tumors (Gliomas); Cancer of the Small Intestine; Hairy Cell Leukemia; Multiple Myeloma
Type of study:Phase II
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Dr. med. Mareike Dietrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02034110
EudraCT: 2013-001705-87 (siehe EU klinisches Studienregister)

AMLSG23-14 / Palbo-AL-1

(second-line)
Title:Phase Ib/IIa Study of Palbociclib in MLL-rearranged Acute Leukemias AMLSG 23-14/Palbo-AL-1
Indication:Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma
Type of study:Phase I/II
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02310243
EudraCT: 2014-003647-34 (siehe EU klinisches Studienregister)

PNH Register

(diagnostisch, Früherkennung, Screening)
Title:Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
Indication:Hemoglobinuria, Paroxysmal
Type of study:Phase N/A
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Dr. med. Christoph Lutz (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01374360
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

AIOP-BFM ALL 2009

(pädiatrisch)
Title:International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
Indication:LeukemiaLeukemia, LymphoidPrecursor Cell Lymphoblastic Leukemia-Lymphoma
Type of study:Phase III
Contact: Donate Jakoby (Study Nurse)
[donate.jakoby@med.uni-heidelberg.de]
Investigator: Dr. med. Wolfgang Behnisch (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01117441
EudraCT: 2007-004270-43 (siehe EU klinisches Studienregister)

IVAC-ALL-1

(pädiatrisch)
Title:Prospective phase I/II study: Patient-individualized peptide vaccination based on whole exome sequencing with adjuvant GM-CSF in children with relapsed acute lymphoblastic leukemia
Indication:lymphatischer Leukämie
Type of study:Phase I/II
Contact: Sabine Brokmeier (Study Nurse)
[s.brokmeier@dkfz-heidelberg.de]
Investigator: Prof. Dr. med. Olaf Witt (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-005281-29 (siehe EU klinisches Studienregister)

Napoleon Register

(Registerstudie)
Title:National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Indication:Leukemia, Promyelocytic, Acute
Type of study:Phase III
Contact: Marianne Gawlik (Kontaktperson)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02192619
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

SAL AML Register

(Registerstudie)
Title:AML-Register und Biomaterial Datenbank der Studienallianz Leukämie
Indication:Leukämie
Type of study:Phase N/A
Contact: Marianne Gawlik (Kontaktperson)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

TRANSATRA

(therapeutisch)
Title:Phase I/II Study of Sensitization of Non-M3 Acute Myeloid Leukemia (AML) Blasts to All-trans Retinoic Acid (ATRA) by Epigenetic Treatment With Tranylcypromine (TCP), an Inhibitor of the Histone Lysine Demethylase 1 (LSD1)
Indication:LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteMyelodysplastic SyndromesPreleukemia
Type of study:Phase I/II
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02717884
EudraCT: 2014-001479-30 (siehe EU klinisches Studienregister)

AC220-007

Title:A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation
Indication:Leukemia, MyeloidLeukemia, Myeloid, Acute
Type of study:Phase III
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02039726
EudraCT: 2013-004890-28 (siehe EU klinisches Studienregister)

AC220-A-U302 / Quantum first

Title:A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Indication:Leukemia, MyeloidLeukemiaLeukemia, Myeloid, Acute
Type of study:Phase III
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02668653
EudraCT: 2015-004856-24 (siehe EU klinisches Studienregister)

BAY 1436032 / 19036

Title:An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated and / or Recommended Phase II Dose of Oral Mutant IDH1 (mIDH1) Inhibitor BAY1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Efficacy in Patients With mIDH1-R132X Advanced Acute Myeloid Leukemia (AML)
Indication:Leukemia, MyeloidLeukemia, Myeloid, Acute
Type of study:Phase I/II
Contact: Diana Six (Study Nurse)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Leiter klinische Prüfung)
Trial Register: No trial registry number given.
EudraCT: 2016-004095-22 (siehe EU klinisches Studienregister)

BLAST (UKH062014)

Title:A Double- Blind, Placebo Controlled, Randomized, Multicenter, Phase II Study to Assess the Efficacy of BL-8040 Addition to Consolidation Therapy in AML Patients
Indication:Leukemia, Myeloid, Acute
Type of study:Phase II
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02502968
EudraCT: 2014-002702-21 (siehe EU klinisches Studienregister)

CLL13 / UNI-KOELN-2751

Title:A Phase 3 Multicenter, Randomized, Prospective, Open-label Trial of Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab Plus Venetoclax (RVe) Versus Obinutuzumab (GA101) Plus Venetoclax (GVe) Versus Obinutuzumab Plus Ibrutinib Plus Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation
Indication:Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Lymphoid
Type of study:Phase III
Contact: Beatrice Müller (Kontaktperson)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02950051
EudraCT: 2015-004936-36 (siehe EU klinisches Studienregister)

CLL2-GIVe

Title:A Prospective, Open-label, Multicentre Phase-II Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Physically Fit or Unfit Patients With Previously Untreated Chronic Lymphocytic Leukemia (Cll) With tp53 Deletion (17p-) and/or Mutation
Indication:LeukemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Lymphoid
Type of study:Phase II
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02758665
EudraCT: 2015-004606-41 (siehe EU klinisches Studienregister)

CLLRUmbrella2 (GS-US-401-2076)

Title:A Prospective, Randomized, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of GS-4059 and Entospletinib With and Without Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia
Indication:Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Lymphoid
Type of study:Phase II
Contact: Monika Fischer (Kontaktperson)
[monika.fischer@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02983617
EudraCT: 2016-002768-15 (siehe EU klinisches Studienregister)

CLLTX1 / ML29747

Title:Obinutuzumab Containing Conditioning Regimen for CLL Patients and Patients With Richter`s Transformation Requiring an Allogeneic Stem Cell Transplantation
Indication:Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Lymphoid
Type of study:Phase II
Contact: Claudia Bruch (Kontaktperson)
[claudia.bruch@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03153514
EudraCT: 2015-00568-32 (siehe EU klinisches Studienregister)

FLYSYN-101

Title:First in Man Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Fc-optimized FLT3 Antibody FLYSYN for the Treatment of Acute Myeloid Leukemia Patients With Minimal Residual Disease
Indication:LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute
Type of study:Phase I
Contact: Marianne Gawlik (Study Nurse)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02789254
EudraCT: 2016-000236-17 (siehe EU klinisches Studienregister)

MLN9708 - C16011

Title:A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Indication:Amyloidosis
Type of study:Phase III
Contact: Cristina Bernardo (Kontaktperson)
[cristina.bernardo@med.uni-heidelberg.de]
Investigator: Dr. med. Stefan Schönland (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01659658
EudraCT: 2011-005468-10 (siehe EU klinisches Studienregister)

MorphoSys Studie (MOR208C2059

Title:A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor
Indication:Leukemia, Lymphocytic, Chronic, B-CellLeukemia, Lymphoid
Type of study:Phase II
Contact: Monika Fischer (Kontaktperson)
[monika.fischer@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02639910
EudraCT: 2015-002915-14 (siehe EU klinisches Studienregister)

Nilo-deep-R (CAMN107ADE20)

Title:A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID
Indication:Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Type of study:Phase IV
Contact: Inge Hotz (Kontaktperson)
[inge.hotz@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02546674
EudraCT: 2015-000968-34 (siehe EU klinisches Studienregister)

PCI-32765CAN3001 (Ibrutinib)

Title:A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Indication:Follicular Leukemia, Lymphoid Lymphoma, B-Cell Lymphoma, Mantle-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large B-Cell, Diffuse
Type of study:Phase III
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01804686
EudraCT: 2012-004225-24 (siehe EU klinisches Studienregister)

TUD-2DAUNO-058 / Dauno Double

Title:Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia =60 Years
Indication:Leukemia, Myeloid Leukemia, Myeloid, Acute
Type of study:Phase III
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02140242
EudraCT: 2013-003191-12 (siehe EU klinisches Studienregister)

TUD-Apollo-064 / Apollo Studie

Title:A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia
Indication:Leukemia, Promyelocytic, Acute
Type of study:Phase III
Contact: Marianne Gawlik (Kontaktperson)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02688140
EudraCT: 2015-001151-68 (siehe EU klinisches Studienregister)

TUD-MIDOKI-052 / Midokit (PKC412)

Title:A Single-arm Phase II Trial to Assess the Efficacy of Midostaurin (PKC412) Added to Standard Primary Therapy in Patients With Newly Diagnosed c-KIT or FLT3-ITD Mutated t(8;21) AML
Indication:Leukemia, Myeloid Leukemia, Myeloid, Acute
Type of study:Phase II
Contact: Marianne Gawlik (Kontaktperson)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Alwin Krämer (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01830361
EudraCT: 2011-002567-17 (siehe EU klinisches Studienregister)

Lymphomas

TTACT (Riemser/ Zetrum 15)

(epidemiologisch)
Title:Eine nicht-interventionelle prospektive Erhebung zur Verträglichkeit und Wirksamkeit von Thiotepa-haltigen Hochdosis-Chemotherapien (HDCT) mit anschließender autologer Stammzelltransplantation im routinemäßigen Einsatz bei erwachsenen Patienten mit mit B- oder T-Zell-Lymphomen (Non Hodgkin Lymphome oder Hodgkin Lymphome) mit oder ohne ZNS-Beteiligung oder mit primärem ZNS-Lymphom
Indication:B- oder T-Zell-Lymphomen
Type of study:Phase N/A
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Knut Schäkel (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

EuroNet-PHL-C2

(pädiatrisch)
Title:Second international inter-Group Study for classical Hodgkin's Lymphoma in childrens an adolescents
Indication:Hodgkin's Lymphoma
Type of study:Phase III
Contact: Renate Sedlak (Kontaktperson)
[renate.sedlak@med.uni-heidelberg.de]
Investigator: Dr. med. Wolfgang Behnisch (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2012-004053-88 (siehe EU klinisches Studienregister)

NHL-BFM Registry 2012

(pädiatrisch, epidemiologisch)
Title:B-NHL BFM 04: Multizentrische Beobachtungsstudie zur Behandlung von Kindern und Jugendlichen mit reifem B-Zell Non-Hodgkin-Lymphom oder B-ALL
Indication:NHL-BFM registry 2012: Registry of the NHL-BFM study group for all subtypes of Non-Hodgkin Lymphoma diagnosed in children and adolescents
Type of study:Phase N/A
Contact: Renate Sedlak (Study Nurse)
[renate.sedlak@med.uni-heidelberg.de]
Investigator: Dr. med. Wolfgang Behnisch (Prüfer)
Trial Register: No trial registry number given.
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

ALTERNATIVE Studie (Mz-135)

Title:Eine Phase II Studie Zur Beurteilung Der Wirksamkeit Von Rituximab in Der Salvage- Und Hochdosistherapie Mit Autologer Stammzelltransplantation Bei Patienten Mit B-Zell-Non-Hodgkin-Lymphom
Indication:Lymphoma, Non-Hodgkin
Type of study:Phase II
Contact: Beatrice Müller (Kontaktperson)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: Dr. med. Sascha Dietrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02099292
EudraCT: 2014-005164-15 (siehe EU klinisches Studienregister)

B-CAP (Uni-Koeln-1707)

Title:Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -
Indication:Lymphoma, Hodgkin Disease
Type of study:Phase II
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. Julia Meißner (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02191930
EudraCT: 2013-003990-89 (siehe EU klinisches Studienregister)

CHARLY Trial

Title:PHASE-II STUDY ON THE VALUE OF POST-TRANSPLANT CYCLOPHOSPHAMIDE AFTER THIOTEPA-BASED HAPLOIDENTICAL STEM CELL TRANSPLANTATION FOR RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA
Indication:non-Hodgkin Lymphoma
Type of study:Phase II
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: Dr. med. Sascha Dietrich (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-003920-30 (siehe EU klinisches Studienregister)

GOAL-Studie

Title:The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma
Indication:Lymphoma, Non-Hodgkin
Type of study:Phase II
Contact: Claudia Bruch (Kontaktperson)
[claudia.bruch@med.uni-heidelberg.de]
Investigator: PD Dr. med. Mathias Witzens-Harig (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02499003
EudraCT: 2014-00480-21 (siehe EU klinisches Studienregister)

HD-R3i (Uni-Koeln-1443)

Title:A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Indication:Lymphoma, Hodgkin Disease
Type of study:Phase I/II
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. Julia Meißner (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01453504
EudraCT: 2010-021086-73 (siehe EU klinisches Studienregister)

HD21(Uni-Koeln-1762)

Title:HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD
Indication:LymphomaHodgkin Disease
Type of study:Phase III
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. Julia Meißner (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02661503
EudraCT: 2014-005130-55 (siehe EU klinisches Studienregister)

MK-3475-204/KEYNOTE-204

Title:A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
Indication:LymphomaHodgkin Disease
Type of study:Phase III
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. Julia Meißner (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT02684292
EudraCT: 2015-005053-12 (siehe EU klinisches Studienregister)

NIVAHL

Title:Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Indication:LymphomaHodgkin Disease
Type of study:Phase II
Contact: Audrey Tan (Kontaktperson)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. Julia Meißner (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03004833
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Optimal>60-Studie / DSHNHL 2009-1

Title:Improvement of Outcome and Reduction of Toxicity in Elderly Patients With CD20+ Aggressive B-Cell Lymphoma by an Optimised Schedule of the Monoclonal Antibody Rituximab, Substitution of Conventional by Liposomal Vincristine, and FDG-PET Based Reduction of Therapy in Combination With Vitamin D Substitution
Indication:Aggression Lymphoma, B-Cell
Type of study:Phase III
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Dr. med. Sascha Dietrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01478542
EudraCT: 2010-019587-36 (siehe EU klinisches Studienregister)

SGN 35 - 014 / ECHELON-2-Studie

Title:A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Indication:Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-CellLymphoma, T-Cell, Peripheral
Type of study:Phase III
Contact: Claudia Bruch (Kontaktperson)
[claudia.bruch@med.uni-heidelberg.de]
Investigator: PD Dr. med. Mathias Witzens-Harig (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT01777152
EudraCT: 2012-002751-42 (siehe EU klinisches Studienregister)

TRIANGLE Studie

Title:Internationale, unverblindete, dreiarmige, parallel randomisierte, Phase III Studie mit 6 alternierenden Kursen R-CHOP/R-DHAP (21 Tage pro Zyklus) gefolgt von autologer Stammzelltransplantation versus ebendieser Kombination mit Ibrutinib in Induktion und Erhaltungstherapie (2 Jahre) oder dem experimentellem Studienarm ohne autologe Stammzelltransplantation.
Indication:mantle cell Lymphoma
Type of study:Phase III
Contact: Beatrice Müller (Kontaktperson)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: Dr. med. Sascha Dietrich (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2014-001363-12 (siehe EU klinisches Studienregister)