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.
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
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
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 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.
Myelodysplastic Syndrome
Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS.
- Trial name
- NCT01062152
- Testing
- Ezatiostat Hydrochloride, Lenalidomide (Revlimid®)
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Telik
Myelodysplastic Syndrome
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main…
- Trial name
- NCT03337451
- Testing
- OPN-305
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Opsona Therapeutics Ltd.
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
Myelodysplastic Syndrome
A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they…
- Trial name
- NCT02363491
- Testing
- OPN-305
- Where
- 4 sites in United States
- Volunteers
- 96 people
- Sponsor
- Opsona Therapeutics Ltd.
Myelodysplastic Syndromes, Anemia
A Phase 2 Study to Evaluate the Safety and Effectiveness of Once Weekly or Once Every Two Week Dosing of Epoetin Alfa in Anemic Patients With Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
The purpose of this study is to evaluate the effectiveness of PROCRIT (Epoetin alfa) 80,000 Units given once weekly or 80,000 Units given once every two weeks in anemic patients with Low- or Intermediate-1 risk Myelodysplastic…
- Trial name
- NCT00446602
- Testing
- Epoetin alfa
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.