Clinical trials: Myelodysplastic Neoplasm
Leukemia, Myelodysplastic Syndromes
A Phase I Study of MGCD0103 Given Twice Weekly in Patients With Leukemia or Myelodysplastic Syndromes
In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to patients with leukemia or myelodysplastic syndromes.
- Trial name
- NCT00324194
- Testing
- MGCD0103
- Where
- 4 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Mirati Therapeutics Inc.
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
Neoplasms
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily (QD) orally.
- Trial name
- NCT01943851
- Testing
- GSK525762
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 111 people
- Sponsor
- GlaxoSmithKline
Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
- Conditions
- Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01474681
- Testing
- HSC835
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
[Tolerability Assessment Part] The purpose is to identify the doses of the oral azacitidine(AZA) formulations and cedazuridine (CED) tablets which achieve a total AUC for AZA comparable to that for AZA injection at 75 mg/m2.
- Trial name
- NCT04608110
- Testing
- ASTX030 (AZA + CED)
- Where
- 10 sites in Japan
- Volunteers
- 59 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
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
Leukemia
Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Trial name
- NCT01378416
- Testing
- Decitabine (Dacogen)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Eisai Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
Caris Chromoseq Data Collection
The study will collect clinical data on patients who receive the Caris Chromoseq assay for an underlying hematologic malignancy.
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Myelodysplatic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT07680868
- Testing
- Caris Chromoseq
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Caris Science, Inc.
Myeloid Leukemia, Lymphoblastic Leukemia
Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related…
- Conditions
- Myeloid Leukemia, Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- Trial name
- NCT00967343
- Testing
- Donor lymphocyte preparation depleted of host functional alloreactive T-cells
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 40 people
- Sponsor
- Kiadis Pharma
Myelodysplastic Syndrome, MDS
Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA
The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have…
- Trial name
- MEI-005 (NCT01993641)
- Testing
- pracinostat, Azacitidine, Decitabine
- Where
- 21 sites in United States
- Volunteers
- 45 people
- Sponsor
- Helsinn Healthcare SA
Myelodysplastic Syndrome
Study of High-Dose Pulse Administration DN-101 (Calcitriol) in Patients With Myelodysplastic Syndrome (MDS)
The purpose of this study is to determine the safety and efficacy of DN-101 (calcitriol) in patients with myelodysplastic syndrome who are dependent on repeat blood transfusions.
- Trial name
- NCT00057031
- Testing
- DN-101 (calcitriol)
- Where
- 10 sites in United States
- Volunteers
- 46 people
- Sponsor
- Novacea
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes
This study is being performed to assess the safety, tolerability, and preliminary clinical effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic…
- Trial name
- NCT02296242
- Testing
- BVD-523
- Where
- 5 sites in United States
- Volunteers
- 53 people
- Sponsor
- BioMed Valley Discoveries, Inc
MDS (Myelodysplastic Syndrome)
Randomized Open-Label Study of INCB047986 in Subjects With Primary Myelodysplastic Syndrome (MDS)
The study design includes a 3-dose randomization phase to determine effective doses of INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to respond to erythropoiesis-stimulating agents…
- Trial name
- NCT02093429
- Testing
- INCB047986
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Incyte Corporation
Myelodysplastic Syndrome
Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients
The purpose of the study is to determine the bioavailability of Azacitidine for Injection relative to Vidaza® in MDS patients under fasting conditions.
- Trial name
- NCT01152346
- Testing
- Azacitidine for Injection, Vidaza®
- Where
- 13 sites in United States, France
- Volunteers
- 19 people
- Sponsor
- Bioniche Pharma USA LLC
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and…
- Trial name
- NCT04953897
- Testing
- ASTX727
- Where
- 21 sites in United States, Armenia and 6 more
- Volunteers
- 18 people
- Sponsor
- Taiho Oncology, Inc.
Myelodysplastic Syndrome, Myelofibrosis
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold…
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT01290302
- Testing
- Luitpold Azacitidine, Vidaza®
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- American Regent, Inc.
Myelodysplastic Syndromes (MDS)
A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)
This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory Myelodysplastic…
- Trial name
- NCT02966782
- Testing
- venetoclax, azacitidine
- Where
- 23 sites in United States, Australia and 1 more
- Volunteers
- 70 people
- Sponsor
- AbbVie
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.
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients
The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02238925
- Testing
- CPX-351
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Jazz Pharmaceuticals
Myelodysplastic Syndromes
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome.
- Trial name
- NCT00017550
- Testing
- anti-thymocyte globulin
- Where
- 28 sites in United States, Canada
- Sponsor
- Genzyme, a Sanofi Company