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
Type of study:Phase II
Contact: Studiensekretariat GMMG (Kontaktperson)
[studiensekretariat.GMMG@med.uni-heidelberg.de]
Investigator: Prof. 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:Multiples Myelom
Type of study:Phase II
Contact: Prof. 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
Type of study:Phase II
Contact: Studien Myelom (Kontaktperson)
[myelom.studien@med.uni-heidelberg.de]
Investigator: Prof. Dr. Marc Raab (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)

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 (E10) (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:Multiples Myelom
Type of study:Phase N/A
Contact: Radiologie, DKFZ (E10) (Kontaktperson)
[-]
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: Studien Myelom (Kontaktperson)
[myelom.studien@med.uni-heidelberg.de]
Investigator: Prof. 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.

APOLLO (EMN14/54767414MMY2013)

Title:A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.
Indication:Multiples Myelom
Type of study:Phase III
Contact: Studien Myelom (Kontaktperson)
[myelom.studien@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 NCT03180736
EudraCT: 2017-001618-27 (siehe EU klinisches Studienregister)

AQUILA

Title:A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects with High-risk Smoldering Multiple Myeloma
Indication:Patienten mit Hochrisiko-Smoulderung Myelom
Type of study:Phase III
Contact: Studien Myelom (Kontaktperson)
[myelom.studien@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 NCT03301220
EudraCT: 2016-001205-16 (siehe EU klinisches Studienregister)

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: Studiensekretariat GMMG (Kontaktperson)
[studiensekretariat.GMMG@med.uni-heidelberg.de]
Investigator: Prof. 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)

EFC12522

Title:A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant
Indication:Multiple Myeloma
Type of study:Phase III
Contact: Studien Myelom (Kontaktperson)
[myelom.studien@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 NCT03319667
EudraCT: 2017-002238-21 (siehe EU klinisches Studienregister)

GMMG HD7

Title:A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
Indication:Multiples Myelom
Type of study:Phase III
Contact: Studiensekretariat GMMG (Kontaktperson)
[studiensekretariat.GMMG@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 NCT03617731
EudraCT: 2017-004768-3 (siehe EU klinisches Studienregister)

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:Multiples Myelom
Type of study:Phase II
Contact: Studiensekretariat GMMG (Kontaktperson)
[studiensekretariat.GMMG@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: Prof. 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:Multiples Myelom
Type of study:Phase I
Contact: Prof. Dr. Hartmut Goldschmidt (Kontaktperson)
[hartmut.goldschmidt@med.uni-heidelberg.de]
Investigator: Prof. 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)

Leukemias

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)

D8230C00001

(second-line)
Title:A Phase 1, Open-Label, Multicentre, Non-Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD4573, a Potent and Selective CDK9 Inhibitor, in Subjects With Relapsed or Refractory Haematological Malignancies
Indication:Leukämie
Type of study:Phase I
Contact: Marianne Gawlik (Study Nurse)
[maria.gawlik@med.uni-heidelberg.de]
Investigator: Prof. Dr. Carsten Müller-Tidow (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03263637
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

PNH Register

(Beobachtungsstudie)
Title:Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
Indication:Paroxysmale nächtliche Hämoglobinurie(PNH)
Type of study:Phase N/A
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@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 NCT01374360
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

CLL-Register

(epidemiologisch)
Title:An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
Indication:Chronisch lymphatische Leukämie
Type of study:Phase N/A
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 NCT01072240
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

GMALL-Register

(epidemiologisch)
Title:GMALL-Register und Biomaterialbank Biomaterialsammlung und prospektive Datenerfassung zu Diagnostik, Behandlung und Krankheitsverlauf der ALL des Erwachsenen
Indication:Akute lymphatische Leukämie
Type of study:Phase N/A
Contact: Audrey Tan (Study Nurse)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (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.

Napoleon Register

(Registerstudie)
Title:National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup
Indication:Neu diagnostizierte/rezidive akute promyelozytäre Leukämie
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:Akute myeloische 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.

RIG-P000814

(therapeutisch)
Title:Multicenter, randomized Phase 2 Trial to determine the Response Rate of Ruxolitinib and Best Available Treatment (BAT) versus BAT in Steroid-refractory acute Graft-versus-Host Disease (aGvHD)
Indication:Graft-versus-Host Erkrankung, akut
Type of study:Phase II
Contact: Max Wingbermühle (Kontaktperson)
[max.wingbermuehle@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2014-004267-20 (siehe EU klinisches Studienregister)

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:Akute myeloische Leukämie, Myelodysplastisches Syndrom
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-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)

AMY3001

Title:A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
Indication:Amyloidose
Type of study:Phase III
Contact: Cristina Bernardo (Study Nurse)
[cristina.bernardo@med.uni-heidelberg.de]
Investigator: Prof. Dr. Stefan Schönland (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03201965
EudraCT: 2016-001737-27 (siehe EU klinisches Studienregister)

BIBF 1120 in AML

Title:A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy
Indication:Akute myeloische Leukämie
Type of study:Phase I/II
Contact: Monika Fischer (Study Nurse)
[monika.fischer@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 NCT01488344
EudraCT: 2011-001086-41 (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:Akute myeloische Leukämie
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)

CABL001A2301

Title:A phase 3, multi-center, open-label, randomized study of oral asciminib versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors
Indication:Chronische myeloische Leukämie
Type of study:Phase III
Contact: Judith Schladitz (Study Nurse)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-002461-66 (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:Chronisch lymphatische Leukämie
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-BAAG

Title:A prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 (obinutuzumab), acalabrutinib (ACP-196) and ABT-199 (venetoclax) in patients with relapsed/refractory CLL (CLL2-BAAG protocol)
Indication:Patienten mit chronischer lymphatischer Leukämie
Type of study:Phase II
Contact: Monika Fischer (Study Nurse)
[monika.fischer@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Peter Dreger (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2017-003133-28 (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:Patienten mit zuvor unbehandelter chronischer lymphatischer Leukämie mit del(17p)/TP53 Mutation
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)

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:Patienten mit MRD-positiver akuter myeloischer Leukämie
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)

GMALL 08/2013

Title:Treatment optimization in adult patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma by individualised, targeted and intensified treatment - a phase IV-trial with a phase III-part to evaluate safety and efficacy of nelarabine in T-ALL patients
Indication:Akute Leukämien: Akute lymphatische Leukämien (ALL)
Type of study:Phase IV
Contact: Audrey Tan (Study Nurse)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2013-003466-13 (siehe EU klinisches Studienregister)

GMALL-MOLACT1-BLINA

Title:A multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lympho-blastic leukemia (Blast Successor Trial)
Indication:Patienten mit minimaler Restkrankheit der akuten lymphatischen Leukämie
Type of study:Phase II
Contact: Audrey Tan (Study Nurse)
[audrey.tan@med.uni-heidelberg.de]
Investigator: Dr. med. Sabine Kayser (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-000733-76 (siehe EU klinisches Studienregister)

HD-CAR-1/V03

Title:Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector - A unicenter Phase I /II clinical trial
Indication:Behandlung von Patienten mit RV-SFG.CD19.CD28.4 retroviralem Vektor transduzierten T-Lymphozyten bei rezidivierenden oder refraktären CD19+ Leukämien und Lymphomen.
Type of study:Phase I/II
Contact: Beatrice Müller (Study Nurse)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: Prof. Dr. Michael Schmitt (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-004808-60 (siehe EU klinisches Studienregister)

National Clinical Amyloidosis Registry

Title:National Clinical Amyloidosis Registry
Indication:Amyloidose
Type of study:Phase N/A
Contact: Rita Ziehl (Kontaktperson)
[Rita.Ziehl@med.uni-heidelberg.de]
Investigator: Prof. Dr. Ute Hegenbart (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.

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: Max Wingbermühle (Study Nurse)
[max.wingbermuehle@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:Chronischer lymphatischer Leukämie
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:Akute Promyelozytenleukämie
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)

Lymphomas

ACE-LY-308 / ACE-196

Title:A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Indication:Unbehandeltes Mantelzell-Lymphom
Type of study:Phase III
Contact: Beatrice Müller (Study Nurse)
[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 NCT02972840
EudraCT: 2015-005220-26 (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:Refraktäres Non-Hodgkin Lymphoma
Type of study:Phase II
Contact: Diana Six (Kontaktperson)
[Diana.Six@med.uni-heidelberg.de]
Investigator: PD Dr. Sascha Dietrich (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2015-003920-30 (siehe EU klinisches Studienregister)

GAZAI

Title:Therapy of Nodal Follicular Lymphoma (WHO Grade 1/2) in Clinical Stage I/II Using Response Adapted Involved Site Radiotherapy in Combination With Gazyvaro
Indication:Follikuläres Lymphom
Type of study:Phase II
Contact: Dr. med. Laila König (Kontaktperson)
[Laila.Koenig@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Klaus Herfarth (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03341520
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

HD-CAR-1/V03

Title:Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector - A unicenter Phase I /II clinical trial
Indication:Behandlung von Patienten mit RV-SFG.CD19.CD28.4 retroviralem Vektor transduzierten T-Lymphozyten bei rezidivierenden oder refraktären CD19+ Leukämien und Lymphomen.
Type of study:Phase I/II
Contact: Beatrice Müller (Study Nurse)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: Prof. Dr. Michael Schmitt (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-004808-60 (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:Fortgeschrittenes Hodgkin-Lymphom
Type of study:Phase III
Contact: Jennifer Klemmer (Kontaktperson)
[jennifer.klemmer@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)

KEYNOTE-348/Blinatumomab

Title:A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (KEYNOTE-348)
Indication:Rezidiviertes oder refraktäres, diffuses großes B-Zelllymphom (DLBCL)
Type of study:Phase I
Contact: Audrey Tan (Study Nurse)
[audrey.tan@med.uni-heidelberg.de]
Investigator: PD Dr. Sascha Dietrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03340766
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

MARTA

Title:Age-adjusted high-dose chemotherapy and autologous stem cell transplant in elderly and fit primary CNS lymphoma patients
Indication:Zerebrales Lymphome
Type of study:Phase III
Contact: Martina Gronkowski (Kontaktperson)
[martina.gronkowski@med.uni-heidelberg.de]
Investigator: Prof. Dr. Gerlinde Egerer (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2016-001628-72 (siehe EU klinisches Studienregister)

NIVAHL

Title:Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Indication:Klassisches Hodgkin-Lymphom
Type of study:Phase II
Contact: Jennifer Klemmer (Kontaktperson)
[jennifer.klemmer@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: 2016-002626-37 (siehe EU klinisches Studienregister)

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:CD20 + Aggressives B-Zell-Lymphom
Type of study:Phase III
Contact: Judith Schladitz (Kontaktperson)
[judith.schladitz@med.uni-heidelberg.de]
Investigator: PD Dr. 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)

R-CHOEP-brut

Title:Ibrutinib and Standard Immuno-Chemotherapy (R-CHOEP-14) in Younger, High-Risk Patients With Diffuse Large B-Cell Lymphoma
Indication:Diffuses großes B-Zell-Lymphom
Type of study:Phase II
Contact: Angela Herrmann (Study Nurse)
[Angela.Herrmann@med.uni-heidelberg.de]
Investigator: PD Dr. Sascha Dietrich (Prüfer)
Trial Register: Die Studie ist bei den "U.S. National Institutes of Health" (ClinicalTrials.gov) registriert. Siehe NCT03399513
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

Register Lymphom

Title:Registerstudie zur Protonen-Radiotherapie bei mediastinalen Lymphomen
Indication:Hodgkin-Lymphom und Non-Hodgkin-Lymphom
Type of study:Phase N/A
Contact: Dr. med. Laila König (Kontaktperson)
[Laila.Koenig@med.uni-heidelberg.de]
Investigator: Prof. Dr. med. Klaus Herfarth (Prüfer)
Trial Register: Die Studie ist beim "DRKS - Deutsches Register Klinischer Studien" registriert. Siehe DRKS00015660
EudraCT: Not stated. Non-interventional studies and studies not controlled by the Medicines Act do not have a EudraCT number.

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:Mantelzell-Lymphom
Type of study:Phase III
Contact: Beatrice Müller (Study Nurse)
[beatrice.mueller@med.uni-heidelberg.de]
Investigator: PD Dr. Sascha Dietrich (Prüfer)
Trial Register: No trial registry number given.
EudraCT: 2014-001363-12 (siehe EU klinisches Studienregister)