Clinical trials: Low to Intermediate-1 MDS
Myelodysplastic Syndrome (MDS)
Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia
Primary Outcome Measures: To evaluate the efficacy of treatment with Azacitidine in patients with transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1, Myelodysplastic Syndrome (MDS) without…
- Trial name
- ABRAZA (NCT01338337)
- Testing
- Azacitidine
- Where
- 9 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Asociación Andaluza de Hematología y Hemoterapia
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, Chronic Myelomonocytic Leukemia
Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with…
- Trial name
- NCT01048034
- Testing
- Azacitidine, Erythropoetin
- Where
- 17 sites in Denmark, Norway and 1 more
- Volunteers
- 30 people
- Sponsor
- Nordic MDS Group
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 Syndromes
Azacitidine Combined to Epoetin Beta in International Prognostic Scoring System (IPSS) Low-risk and Intermediate-1 Myelodysplastic Syndrome (MDS) Patients, Resistant to Erythropoetin-stimulating Agents (ESA)
The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA).
- Trial name
- NCT01015352
- Testing
- Azacitidine, Epoetin beta
- Where
- 29 sites in France
- Volunteers
- 98 people
- Sponsor
- Groupe Francophone des Myelodysplasies
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.
Myelodysplastic Syndrome, MDS
Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome
The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in…
- Conditions
- Myelodysplastic Syndrome, MDS, Trisomy 8
- Trial name
- ONTARGET (NCT01584531)
- Testing
- rigosertib
- Where
- 5 sites in United States
- Volunteers
- 82 people
- Sponsor
- Traws Pharma, Inc.
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.
MDS
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk…
- Trial name
- NCT01497145
- Testing
- KRN321
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 45 people
- Sponsor
- Kyowa Kirin Co., Ltd.