Clinical trials: High-Risk Myelodysplastic Syndromes
Acute Myelogenous Leukemia in Relapse, Acute Myelogenous Leukemia, Relapsed, Adult
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard…
- Conditions
- Acute Myelogenous Leukemia in Relapse, Acute Myelogenous Leukemia, Relapsed, Adult, Acute Myelogenous Leukemia, Adult, Acute Myelogenous Leukemia
- Trial name
- NCT02267863
- Testing
- APTO-253
- Where
- 13 sites in United States
- Volunteers
- 21 people
- Sponsor
- Aptose Biosciences Inc.
Myelodysplastic Syndromes
Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes
Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available.
- Trial name
- NCT04484363
- Testing
- Pevonedistat, Azacitidine
- Sponsor
- Takeda
Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndromes
Study of CB-5339 in Acute Myeloid Leukemia or Myelodysplastic Syndrome
This is a multicenter, open-label Phase 1 study of orally administered CB-5339 in participants with R/R AML or participants with R/R intermediate- to high-risk MDS.
- Trial name
- NCT04402541
- Testing
- CB-5339
- Where
- 10 sites in United States, Australia
- Volunteers
- 55 people
- Sponsor
- Cleave Therapeutics, Inc.
Myelodysplastic Syndromes
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome
This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with…
- Trial name
- NCT04797780
- Testing
- Tamibarotene, Azacitidine
- Where
- 128 sites in United States, Austria and 11 more
- Volunteers
- 246 people
- Sponsor
- Syros Pharmaceuticals
Acute Leukemia, Myelodysplastic Syndrome
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
- Trial name
- NCT07573111
- Testing
- QUAIL-100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Laguna Biotherapeutics, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab
The primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat…
- Trial name
- NCT04320602
- Testing
- Eculizumab, Ravulizumab
- Where
- 4 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine…
- Trial name
- NCT02319369
- Testing
- Milademetan, AZA
- Where
- 5 sites in United States
- Volunteers
- 74 people
- Sponsor
- Daiichi Sankyo
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic…
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes
- Trial name
- MOMENTUM (NCT07155226)
- Testing
- AZD3632, Posaconazole
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Myelodysplastic Syndromes(MDS)
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in…
- Trial name
- NCT05709093
- Testing
- Lemzoparlimab+Azacitidine (AZA), Azacitidine (AZA)
- Where
- 44 sites in China
- Volunteers
- 10 people
- Sponsor
- TJ Biopharma Co., Ltd.
Myelodysplastic Syndrome
A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome
This is a open label, phase I/II study. All patients are diagnosed with higher-risk MDS, Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Trial name
- NCT04900350
- Testing
- AK117, Azacitidine
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Akeso
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
AML
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the…
- Trial name
- VOYAGE (NCT02152956)
- Testing
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- Where
- 43 sites in United States, France and 6 more
- Volunteers
- 244 people
- Sponsor
- MacroGenics
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
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.
Higher Risk Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia
The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic…
- Trial name
- NCT05209152
- Testing
- AMG 176, Azacitidine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Amgen
Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in…
- Trial name
- BRAMLIE (NCT07723703)
- Testing
- AMX-883, Posaconazole
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Amphista Therapeutics Ltd
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory…
- Trial name
- NCT05732103
- Testing
- CTX-712
- Where
- 8 sites in United States
- Volunteers
- 225 people
- Sponsor
- Chordia Therapeutics, Inc.
MDS, AML
Non-interventional Study With Azacitidin (Vidaza®)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
- Conditions
- MDS, AML, CMMOL
- Trial name
- Piaza (NCT01192945)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- iOMEDICO AG