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  1. Eltrombopag versus placebo for low-risk myelodysplastic syndromes with thrombocytopenia (EQoL-MDS): phase 1 results of a single-blind, randomised, controlled, phase 2 superiority trial.

    ... (2:1) to receive eltrombopag (50 mg to 300 mg) or placebo for at least 24 weeks and until disease progression and were masked ... the eltrombopag group versus one (3%) of 31 patients in the placebo group (odds ratio 27·1 [95% CI 3·5-211·9], p=0·0017). During the ...

    Research Article last updated 02/21/2017 - 9:49am.

  2. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents

    ... PURPOSE: This international phase III, randomized, placebo -controlled, double-blind study assessed the efficacy and safety of ... assigned (2:1) to treatment with lenalidomide (n = 160) or placebo (n = 79) once per day (on 28-day cycles). The primary end point was the ...

    Research Article last updated 07/18/2016 - 10:30am.

  3. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q

    ... 69) or 5 mg/day days 1-28 (n = 69) of 28-day cycles; or placebo (n = 67). Crossover to lenalidomide or higher dose was allowed ... (TI) for ≥ 26 weeks (primary endpoint) versus placebo (56.1% and 42.6% vs 5.9%; both P < .001). Median duration of RBC-TI was ...

    Research Article last updated 07/28/2014 - 9:04am.

  4. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes

    ... 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin ... 5-24 was significantly lower with darbepoetin alfa versus placebo (36.1% [35/97] versus 59.2% [29/49], P=0.008] and erythroid response ...

    Research Article last updated 07/11/2017 - 10:16am.

  5. A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

    ... 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the ... This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care ...

    Clinical Trial last updated 04/27/2016 - 1:28pm.

  6. 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

    ... Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell ... daily, First 21 days of each 28-day cycle Drug: Placebo Placebo, First 21 days of each 28-day cycle ...

    Clinical Trial last updated 04/27/2016 - 9:52am.

  7. GVAX vs. Placebo for MDS/AML After Allo HSCT

    ... be "randomized" to receive either GVAX vaccination or placebo (a saline solution) vaccination. Randomization means that you are ... receive the GVAX vaccine and a 50% chance you will receive placebo. Neither you nor your transplant doctor(s) will know which you will be ...

    Clinical Trial last updated 04/28/2016 - 12:01pm.

  8. Advances in antiviral drug cuts infection post SCT

    ... research centers in 20 countries, compared letermovir to placebo in preventing an active CMV infection following transplant with ... weeks of treatment, 61 percent of the patients receiving a placebo had developed a CMV infection serious enough to require treatment or ...

    Article last updated 02/23/2017 - 7:26am.

  9. Phase 2, randomized, double-blind study of pracinostat in combination with azacitidine in patients with untreated, higher risk myelodysplastic syndromes

    ... azacitidine . METHODS: A phase 2 randomized, placebo -controlled clinical trial of azacitidine and pracinostat ... there were 51 in the pracinostat group and 51 in the placebo group. The median age was 69 years. The CR rate by cycle 6 of therapy ...

    Research Article last updated 02/03/2017 - 11:12am.

  10. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and po

    ... Based on the results of this study, the randomized, placebo -controlled phase 3 QUAZAR Lower-Risk MDS trial (AZA-MDS-003) was ... design and rationale for this trial comparing CC-486 with placebo for the treatment of patients with IPSS lower-risk MDS with poor ...

    Research Article last updated 06/23/2016 - 10:17am.