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NCT02775903 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
A Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT02775903: Completed Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Celgene.
NCT02775903 is a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute that has completed, run by Celgene. The registered enrollment target is 213 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02775903, a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.
Primary Outcome
Overall response rate (ORR) is defined as the percentage of participants achieving a complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI) based on International Working Group (IWG) 2006 response criteria for MDS and central review. CR: ≤ 5% myeloblasts in bone marrow (BM), and peripheral blood: hemoglobin ≥ 11 g/dL; platelets ≥ 100 × 10⁹/L; neutrophils ≥ 1.0 × 10⁹/L; blasts 0% PR: BM blasts decreased by ≥ 50% but still \> 5%; per
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- DRUG Azacitidine
Study Locations (20)
Other
- Medizinische Universitat Graz - Graz
- Medizinische Universitat Innsbruck - Innsbruck
- Elisabethinen Hospital Linz - Linz
- Salzburger Landkliniken St. Johanns-Spital - Salzburg
- Hanusch Krankenhaus der Stadt Wien - Vienna
- Local Institution - 653 - Vienna
- AKH Wien - Wein
- Cliniques Universitaires St-Luc - Brussels
Florida
- University of Florida - Gainesville
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Cancer Institute - Buffalo
- Icahn School of Medicine at Mount Sinai - New York
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Georgetown University Hospital - Washington D.C.
Illinois
- University of Chicago - Chicago
New Jersey
- Hackensack University Medical Center - Hackensack
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2016-06-03 |
| Est. Completion | 2021-12-27 |
| Phase | Phase 2 |
What the finished NCT02775903 record still lists
NCT02775903 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (25% lower).
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT02775903 names 20 study sites across 11 states, led by Other, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT02775903 about?
NCT02775903 is a clinical study titled "An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)". The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously un...
What is the current status of trial NCT02775903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 213 participants. The study started on 2016-06-03. Estimated completion is 2021-12-27.
What conditions does trial NCT02775903 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT02775903?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT02775903?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02775903 being conducted?
This trial has 20 study locations across Connecticut, District of Columbia, Florida, Illinois, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02775903's enrollment target sits among peer trials
213 31st of 173 higher than 143 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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