Clinical trials: Low to Intermediate-1 MDS
Myelodysplastic Syndrome (MDS)
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01459159
- Testing
- ezatiostat hydrochloride (Telintra®)
- Where
- 7 sites in United States
- Volunteers
- 162 people
- Sponsor
- Telik
Myelodysplastic Syndrome (MDS)
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS.
- Trial name
- NCT00700206
- Testing
- Ezatiostat Hydrochloride
- Where
- 36 sites in United States
- Volunteers
- 86 people
- Sponsor
- Telik
Myelodysplastic Syndrome
Three Dosing Schedules of Oral Rigosertib in MDS Patients
This study will compare the dosing regimen of oral rigosertib, which has been used in other studies of lower risk Myelodysplastic Syndrome (MDS), with 2 new dosing regimens to determine if one of the new regimens gives improved…
- Trial name
- NCT02075034
- Testing
- rigosertib
- Where
- United States
- Sponsor
- Traws Pharma, Inc.
Leukemia
Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease
The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in patients with MDS. This is an investigational study. Up to 240 participants will be enrolled in this multicenter study.
- Trial name
- NCT02378701
- Testing
- QUALMS-1 Questionnaire, FACT-An Questionnaire
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- M.D. Anderson Cancer Center
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
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors.
- Trial name
- NCT03886662
- Testing
- LB-100
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Lixte Biotechnology Holdings, Inc.
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 Syndromes
Multicentric Study Comparison Between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid 13-cis-retinoic and Dihydroxyvitamin D3 in Myelodysplastic Syndromes Without Excess of Blasts
This is a prospective, randomized multicenter phase III clinical trial designed to evaluate the safety and activity of comparison between Erythropoietin and Erythropoietin Associated to Differentiating Therapy With Acid…
- Trial name
- NCT00804050
- Testing
- infusion A: rEPO, B Infusion rEPO combined with vitamins pills
- Where
- 18 sites in Italy
- Volunteers
- 184 people
- Sponsor
- Fondazione Italiana Sindromi Mielodisplastiche-ETS
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 Syndrome (MDS)
Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to…
- Trial name
- NCT01422486
- Testing
- ezatiostat hydrochloride (Telintra®)
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Telik
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 Syndrome
SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome
The primary objective is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety of the treatment.
- Trial name
- SIMIDIS (NCT00495547)
- Testing
- Azacitidine, Beta Erythropoietin
- Where
- 10 sites in Spain
- Volunteers
- 16 people
- Sponsor
- PETHEMA Foundation
Myelodysplastic Syndromes
Oral Rigosertib in Low Risk MDS Patients Refractory to ESAs
The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents.
- Trial name
- NCT01904682
- Testing
- Oral rigosertib
- Where
- 14 sites in United States, France and 1 more
- Volunteers
- 45 people
- Sponsor
- Traws Pharma, Inc.
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.