| Indikation | Kurzbezeichnung | Eudra-CT Nr | Phase | Titel |
|---|---|---|---|---|
| NHL indolent | INCMOR 0208-301 | 2020-004407-13 | III | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma |
| Waiha | Incyte 5046-309 | 2021-002844-66 | III | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia |
| MPN | CA011-23 | 2020-002071-35 | Ib/2 | A Phase 1b Study of BMS-986158 Monotherapy and in Combination with Either Ruxolitinib or Fedratinib in Participants with DIPSS-Intermediate or High Risk Myelofibrosis |
| Akute Leukämie | HaploMUDStudy | 2017-002331-41 | II | Matched Unrelated vs. Haploidentical Donor for Allogenic Stem Cell Transplantation in Patients with Acute Leukemia with Identical GVHD- Prophylaxis - A Randomized Prospective European Trial |
| GVHD | MC-MSC.1/aGvHD-IDUNN | 2019-001462-15 | III | A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment with Mesenchymal Stomal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid-refractory Acute Graft-versus-host Disease After Allogenic Haematopoietic Stem Cell Transplantation (IDUNN Trial) |
| GVHD | GRAPPA | 2021-000853-17 | II/III | Graft vs Host Disease Prophylaxis in unrelated donor transplantation: a randomized clinical trial comparing PTCY vs ATG |
| AML oder MDS | MC-FludT.18/QT | 2021-005433-16 | I (Special pharmocological study) | Phase I trial to access the cardiac safety of Treosulfan-bases conditioning therapy in subjects with AML or MDS undergoing allogenic hematopoietic stem cell transplantation |
| Multiples Myelom | AlloRelapseMMStudy | 2021-001005-67 | III | Allogenic stem cell transplantation vs. Conventional therapy as salvage therapy for relapsed / progressive patients with multiple myeloma subsequent a first-line therapy |
| NHL indolent | MZoL Register | na | folgt | Nicht-interventionelles prospektives Register zu Epidemiologie und Behandlungspraxis bei Marginalzonenlymphomen |
| Basket | MK7684A-004 | 2021-001700-15 | II | A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies |
| Hodgkin | HD 21 | 2014-005130-55 | III | HD 21 for advanced stages. Treatment optimization trial in the first line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD |
| NHL aggressiv | GCT3013-05 | 2020-003016-27 | III | Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma. |
| NHL aggressiv | Chart Review | folgt | Retrospective Chart Review for German adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy with subsequent historical comparison against tisagenlecleucel based on the Juliet trial | |
| Basket | Genmab 3013 GCT3013-01 | 2017-001748-36 | I/II | A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma |
| NHL | PTLD Register | folgt | Nichtinterventionelle, prospektive Registerstudie zur Behandlungspraxis der PTLD in der klinischen Routine | |
| NHL aggressiv | Daly2 MB-2020-371 | 2020-003908-14 | II | A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation |
| NHL aggressiv | MB-CART2019.1 M-2018-331 | 2018-001253-27 | I/II | A Phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or refractory CD20 and CD19 positive B-NHL |
| NHL aggressiv | MOR208C310 frontMIND | 2020-002990-84 | III | A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newlydiagnosed diffuse large B-cell lymphoma (DLBCL) |
| Basket | Viracta VT3996-202 | 2020-005197-10 | II | An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Subjects With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (“NAVAL-1”) |
| Thalassämie | Energize AG348-C-017 | 2021-000211-23 | III | A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects with Non–Transfusion-Dependent Alpha- or Beta Thalassemia (ENERGIZE |
| Thalassämie | Energize T AG348-C-018 | 2021-000212-34 | III | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects with Transfusion-Dependent Alpha- or Beta Thalassemia (ENERGIZE T) |
| CLL | CLL Frail | II | A PROSPECTIVE, MULTICENTRE PHASE-II TRIAL OF ACALABRUTINIB IN VERY OLD (>80Y) OR FRAIL PATIENTS WITH CLL |
|
| CLL | CLL Register | n/a | folgt | Registry of the German CLL Study Group: Long term follow-up of patients with CLL, B-PLL, T-PLL, SLL, T/NK-LGL, HCL and Richter´s transformation |
| CLL | CLL 16 | 2020-004360-26 | IIT | A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK (17P-DELETION, TP53- MUTATION OR COMPLEX KARYOTYPE) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) |
| CML | CABL001 | n/a | Phama | 1st line |
| ALL | Gmall Bliven | n/a | IIT | An open label, phase I/II study of Venetoclax in addition to Blinatumomab immunotherapy in adult patients with relapsed /refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL) |
| AML | AML-Register | n/a | AML-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL) | |
| AML | TUD-MOSAIC-075 | 2019-003863-23 | II | Multizentrische Studie mit Phase-I-Teil im 3+3 Studiendesign (MODULE) und einem randomisiert kontrollierten doppelblinden (MAGNOLIA) und randomisierten unverblindeten (MAGMA) Phase-II-Teil |
| AML | Relax | 2018-003025-28 | I / II | Phase-I/II trial for relapsed or refractory AML patients combining cytarabine and mitoxantrone with venetoclax (RELAX) |
| AML/MDS | PALOMA | 2018-002430-21 | II | Primary comparison of liposomal Anthracycline based treatment versus conventional care strategies before allogeneic cell transplantation in patients with higher risk MDS and oligoblastic AML - the PALOMA study |
| APL | NAPOLEON-Register | National Acute Promyelocytic Leukemia (APL) Observational Study Napoleon-Registry of the German AML-Intergroup | ||
| ALL | GMALL-INITIAL-1 | 2016-004836-39 | II | An open label phase II study to evaluate the efficacy and safety of inotuzumab ozogamicin for induction therapy followed by a conventional chemotherapy based consolidation and maintenance therapy in patients aged 56 years and older with acute lymphoblastic leukemia (ALL) |
| ALL | ALL-Register | GMALL Register | ||
| MPN | MPN-Register | n/a | folgt | SAL-MPN-Register und Biomaterieldatenbank der Studienallianz Leukämie (SAL) |
| MPN | Besremi-PASS EUPAS29462 | Anwendungsbeobachtung | A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients |
|
| PNH | PNH-Register | folgt | M07-001, 914007 Register für paroxysmale nächtliche Hämoglobinurie (PNH) | |
| PNH | BO42161 Commodore 1 switch | 2019-004931-21 | III | A Phase III, randomized, open-label, active-controlled, multicenter study evaluating the efficacy and safety of crovalimab versus eculizumab in adult and adolescent patients with PNH currently treated with complement inhibitors |
| PNH | ALXN2040-PNH-301 | 2019-003829-18 | folgt | A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)” |
| PNH | RavuReWo | folgt | III | Analysis/Outcomes of Patients who switched from being under eculizumab to ravulizumab treatment in a real-world setting – according to the label but not included in Phase 3 studies RavuReWo |
| Waiha | ANX-wAIHA-01 | folgt | folgt | “A Study to Evaluate the Complement Signature of Subjects with Warm Autoimmune Hemolytic Anemia “ |
| Waiha | MOM-M281-006 | 2019-000720-17 | II/III | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study with a Long-term Open-label Extension |
| AA | EMAA 9345 | 2014-000174-19 | II/III | Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A. Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag (Revolade ®, GlaxoSmithKline) with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A |
| Waiha | ACT16832 | 2020‐003880‐24 | 1b + II | A multicenter, open-label, Phase 1b/2 study to evaluate the safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in patients with primary warm autoimmune hemolytic anemia |
| Hämolyse | CLNP023L12201 | II | An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan(LNP023) in participants with autoimmune benignhematological disorders | |
| ZNS Lymphome | Optimate | 2018-002115-96 | III | OptiMATe - Optimizing MATRix as remission induction for PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial“ |
| MM | Regeneron 5458-ONC-1826 | folgt | I / II | PHASE 1/2 FIH STUDY OF REGN5458 (ANTI-BCMA X ANTI-CD3 BISPECIFIC ANTIBODY) IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA |
| MM | GMMG-CONCEPT | 2016-000432-17 | II | Eine klinische Phase II Studie zur Induktions-, Konsolidierungs- und Erhaltungstherapie mit Isatuximab, Carfilzomib, Lenalidomid und Dexamethason (I-KRd) in der Primärtherapie des Hochrisikomyeloms |
| AL-Amyloidose | CAEL101-301 | III | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis | |
| AL-Amyloidose | CAEL101-302 | III | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis | |
| AL-Amyloidose | Amyloidose Register | folgt | Nationales klinisches Amyloidose-Register | |
| MM | C1071007 | 2021-006052-14 | III | A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO ARE MINIMAL RESIDUAL DISEASE-POSITIVE AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION |
©2020
Klinik für Hämatologie und Stammzelltransplantation