Clinical trials: Higher-risk Myelodysplastic Syndromes
Myelogenous Leukemia, Acute, Myelodysplastic Syndromes
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with…
- Trial name
- NCT00374296
- Testing
- MGCD0103
- Where
- 13 sites in United States, Canada
- Volunteers
- 35 people
- Sponsor
- Mirati Therapeutics Inc.
R/R AML, R/R HR-MDS
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Conditions
- R/R AML, R/R HR-MDS, Acute Myeloid Leukemia, Higher-Risk Myelodysplastic Syndrome
- Trial name
- NCT07384715
- Testing
- GEN3018
- Where
- 9 sites in Denmark, Italy and 1 more
- Volunteers
- 78 people
- Sponsor
- Genmab
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome
Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory…
- Trial name
- RIVER-52 (NCT06268574)
- Testing
- RVU120
- Where
- 41 sites in France, Italy and 2 more
- Volunteers
- 62 people
- Sponsor
- Ryvu Therapeutics SA
Myelodysplastic Syndrome (MDS)
A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
The purpose of the study was to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, was safe and had beneficial effects in participants with high or very high risk myelodysplastic…
- Trial name
- STIMULUS-MDS3 (NCT04812548)
- Testing
- sabatolimab, azacitidine, venetoclax
- Where
- 10 sites in Belgium, France and 5 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, Inc.
Hematologic Malignancies
Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.
- Trial name
- NCT02487459
- Testing
- BPX-501, AP1903
- Where
- United States
- Sponsor
- Bellicum Pharmaceuticals
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who…
- Trial name
- NCT02775903
- Testing
- Azacitidine, Durvalumab
- Where
- 103 sites in United States, Austria and 10 more
- Volunteers
- 213 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes
Study of REM-422 in Patients With AML or Higher Risk MDS
The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML
- Conditions
- Myelodysplastic Syndromes, Higher Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, Acute Myeloid Leukemia Refractory
- Trial name
- NCT06297941
- Testing
- REM-422
- Where
- 9 sites in United States, France
- Volunteers
- 100 people
- Sponsor
- Remix Therapeutics
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS
This is a two strata Phase 1b study to assess the safety and efficacy of bisantrene (RC110) in combination with a) cytarabine arabinoside (Ara-C) treatment for patients with relapsed or refractory (R/R) Acute Myeloid Leukemia…
- Conditions
- Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Higher Risk Myelodysplastic Syndrome
- Trial name
- BISECT (NCT05456269)
- Testing
- Bisantrene Dihydrochloride (high dose), Bisantrene Dihydrochloride (low dose), Cytarabine Hydrochloride
- Where
- Australia
- Sponsor
- Racura Oncology Ltd
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia (CMML)
SNS-301 Monotherapy in High Risk MDS and CMML
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.
- Trial name
- NCT04217720
- Testing
- SNS-301
- Sponsor
- Sensei Biotherapeutics, Inc.
Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
- Conditions
- Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- Trial name
- NCT06034275
- Testing
- VIP943 (QW), VIP943 (BIW)
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Vincerx Pharma, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT02610777
- Testing
- Azacitidine, Pevonedistat
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 120 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Leukemia, Myelodysplastic Syndromes
Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT
This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease…
- Conditions
- Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple Myeloma
- Trial name
- NCT02786485
- Testing
- rivogenlecleucel, Rimiducid
- Sponsor
- Bellicum Pharmaceuticals
Myelodysplastic Syndromes
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason…
- Trial name
- NCT02281084
- Testing
- Oral Azacitidine, Durvalumab
- Where
- 89 sites in United States, Australia and 8 more
- Volunteers
- 65 people
- Sponsor
- Celgene
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias
The primary objective of this study is to determine the maximum tolerated dose, dose limiting toxicity, safety and tolerability of TH-302 in patients with acute leukemias, advanced phase chronic myelogenous leukemia (CML), high…
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, High-risk Myelodysplastic Syndrome
- Trial name
- NCT01149915
- Testing
- TH-302
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Threshold Pharmaceuticals
Higher Risk Myelodysplastic Syndromes
Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with…
- Trial name
- BEXERA (NCT07672769)
- Testing
- bexmarilimab (1mg/kg), azacitidine, bexmarilimab (3mg/kg)
- Where
- 35 sites in United States, Czechia and 5 more
- Volunteers
- 90 people
- Sponsor
- Faron Pharmaceuticals Ltd
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate…
- Trial name
- NCT02201329
- Testing
- Azacitidine, Volasertib
- Where
- 4 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim