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A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

Study acronym: COSI
StatusActive, Not Recruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary and study completion dates: Mar 2025 to May 2026
    • Collaborators: 3 to 2
    v6
  2. Primary completion date: Jan 2024 to Mar 2025v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 394 to confirmed 333
    • Study completion date: Jan 2026 to Mar 2025
    • Site details revised at 14 of 14 sites
  3. Phase: Phase 3 to Phase 2/3v4 Show 6 more changesShow less
    • Enrollment target: 760 to 394
    • Study sites: 1 to 14
    • Eligibility criteria expanded, about 181 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 10 words
    • Collaborators expanded, about 16 words
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2020 to Jan 27, 2020
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a major advance such transplants are associated with a high risk of disease relapse particularly in patients with high risk disease. This study will evaluate new transplant strategies with the aim of improving the outcome of patients with AML and high risk MDS after stem cell transplantation. Three approaches to improve transplant outcome will be studied: 1. Comparing the new pre-transplant consolidation therapy vyxeos with the standard consolidation therapy (Randomisation 1 is now closed to recruitment). 2. Comparing new conditioning therapies in patients under the age of 55 years 3. Comparing new conditioning therapies in patients aged 55 and over All patients will be followed up for a minimum of 2 years.
Trial Details
NCT Number NCT04217278
Lead Sponsor University of Birmingham
Collaborators: Jazz Pharmaceuticals, Adienne SA
Conditions
(from sponsor)		 Acute Myeloid Leukaemia, High-risk Myelodysplastic Syndrome
Related terms Leukemia, Myeloid, Acute
Enrollment 333 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov