Clinical trials: Low to Intermediate-1 MDS
Anemia, Myelodysplastic Syndromes
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk…
- Conditions
- Anemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Low to Intermediate-1 MDS
- Trial name
- NCT01736683
- Testing
- Sotatercept
- Where
- 20 sites in United States, France
- Volunteers
- 74 people
- Sponsor
- Merck Sharp & Dohme LLC
Myelodysplastic Syndromes
Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003)
This study is an open-label extension study for participants previously enrolled in study MK-6143-001 (formerly called A536-03, ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of…
- Trial name
- NCT02268383
- Testing
- Luspatercept
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
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
Leukemia
Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01222195
- Testing
- Lenalidomide, Darbepoetin alfa
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- M.D. Anderson Cancer Center
Myelodysplastic Syndrome
A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01513317
- Testing
- Siltuximab, Best supportive care (BSC)
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 76 people
- Sponsor
- Janssen Research & Development, LLC
Myelodysplastic Syndromes
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to evaluate the efficacy and safety of imetelstat sodium in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to…
- Trial name
- NCT02598661
- Testing
- Imetelstat Sodium
- Where
- 126 sites in United States, Belgium and 15 more
- Volunteers
- 289 people
- Sponsor
- Geron Corporation
Anemia, Chronic Myelomonocytic Leukemia
Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
- Conditions
- Anemia, Chronic Myelomonocytic Leukemia, De Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome
- Trial name
- NCT00843882
- Testing
- Bone Marrow Biopsy, Epoetin Alfa, Laboratory Biomarker Analysis
- Where
- 507 sites in United States
- Volunteers
- 247 people
- Sponsor
- National Cancer Institute (NCI)
Myelodysplastic Syndromes
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes…
- Trial name
- NCT02240706
- Testing
- Best Supportive Care, BI 836858
- Where
- 5 sites in United States, Germany
- Volunteers
- 27 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndrome, MDS
A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality called "deletion 5q" in Low and Intermediate-1…
- Conditions
- Myelodysplastic Syndrome, MDS, Low to Intermediate-1 MDS, Non-deletion 5q
- Trial name
- NCT00699842
- Testing
- Lenalidomide
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Myelodysplastic Syndromes
Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia
There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as…
- Trial name
- EUROPE (NCT02335268)
- Testing
- N-Plate / romiplostim
- Where
- 36 sites in France, Germany
- Volunteers
- 77 people
- Sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
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.
Myelodysplastic Syndrome (MDS)
Darbepoetin Alfa MDS Companion Protocol
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for…
- Trial name
- NCT02175277
- Testing
- Darbepoetin Alfa
- Where
- 4 sites in Belgium
- Volunteers
- 9 people
- Sponsor
- Amgen
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
Myelodysplastic Syndrome (MDS)
Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome
This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents…
- Trial name
- RISE (NCT00542828)
- Testing
- Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 16 people
- Sponsor
- Genzyme, a Sanofi Company
Thrombocytopenia, MDS
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
- Conditions
- Thrombocytopenia, MDS, Myelodysplastic Syndromes, Refractory Cytopenias
- Trial name
- NCT00303472
- Testing
- Romiplostim
- Volunteers
- 72 people
- Sponsor
- Amgen
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.