Clinical trials: Preleukemia
Myelodysplastic Syndromes
Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic…
- Trial name
- NCT03011034
- Testing
- Talacotuzumab, Daratumumab
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Paroxysmal Nocturnal Hemoglobinuria
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria .
- Trial name
- NCT04085601
- Testing
- APL-2
- Where
- 30 sites in Colombia, Hong Kong and 8 more
- Volunteers
- 53 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
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
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts.
- Trial name
- NCT02712905
- Testing
- INCB059872, all-trans retinoic acid (ATRA), azacitidine
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 116 people
- Sponsor
- Incyte Corporation
Myelodysplastic Syndromes
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk…
- Trial name
- ENHANCE (NCT04313881)
- Testing
- Magrolimab, Azacitidine
- Where
- 169 sites in United States, Australia and 19 more
- Volunteers
- 539 people
- Sponsor
- Gilead Sciences
Myelodysplastic Syndromes, Thrombocytopenia
A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS)…
- Trial name
- NCT00418665
- Testing
- AMG 531
- Volunteers
- 39 people
- Sponsor
- Amgen
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute…
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)
- Trial name
- NCT02730299
- Testing
- NiCord® (omidubicel), Cord Blood Unit
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Gamida Cell ltd
Myelodysplastic Syndromes
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at…
- Trial name
- COMMANDS (NCT03682536)
- Testing
- Luspatercept, Epoetin alfa
- Where
- 226 sites in United States, Australia and 24 more
- Volunteers
- 363 people
- Sponsor
- Celgene
High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid…
- Conditions
- High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT03214666
- Testing
- GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GT Biopharma, Inc.
Single Umbilical Cord Blood Transplantation, Non-myeloablative Conditioning
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB)…
- Conditions
- Single Umbilical Cord Blood Transplantation, Non-myeloablative Conditioning, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome
- Trial name
- UCBT (NCT01930162)
- Testing
- HSC835
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes, Anemia
A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion
The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS).
- Trial name
- NCT00695396
- Testing
- Epoetin alfa
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Thrombocytopaenia
A Rollover Study to Provide Continued Treatment With Eltrombopag
The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374)…
- Trial name
- NCT01957176
- Testing
- Eltrombopag (ELT)
- Where
- 13 sites in Belgium, China and 10 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML)
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Non-Hodgkin's Lymphoma
- Trial name
- NCT01221857
- Testing
- NiCord®
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Gamida Cell ltd
MDS, CMML
SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Phase 1-2 dose-escalation randomized study in participants with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML).
- Conditions
- MDS, CMML, AML
- Trial name
- NCT01261312
- Testing
- Guadecitabine
- Where
- 16 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. Pegcetacoplan (APL-2) in PNH Subjects.
The objectives of the study are to assess the safety, tolerability, preliminary efficacy and PK of multiple subcutaneous (SC) doses of pegcetacoplan in subjects with paroxysmal nocturnal hemoglobinuria (PNH) who have not received…
- Trial name
- PADDOCK (NCT02588833)
- Testing
- Pegcetacoplan
- Where
- 7 sites in Hong Kong, Malaysia and 2 more
- Volunteers
- 23 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and…
- Trial name
- NCT01957644
- Testing
- Azacitidine, Volasertib
- Where
- 14 sites in France, Germany
- Volunteers
- 16 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndrome
A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
- Trial name
- NCT00619099
- Testing
- decitabine
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- Eisai Inc.
Myelodysplastic Syndrome
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to…
- Trial name
- NCT01566695
- Testing
- Oral Azacitidine, Best Supportiv Care (BSC)
- Where
- 196 sites in United States, Australia and 21 more
- Volunteers
- 216 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
A Study of Galunisertib in Participants With Myelodysplastic Syndromes
The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS).
- Trial name
- NCT02008318
- Testing
- Galunisertib
- Where
- 14 sites in Germany, Italy and 1 more
- Volunteers
- 43 people
- Sponsor
- Eli Lilly and Company