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NCT04526288

CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

Terminated Phase 2 Results posted Last updated 23 May 2024
What this trial tests

Phase 2 trial testing Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia in 1 participant. Terminated before completion.

Timeline
9 August 2021
Primary endpoint
27 August 2023
27 August 2023

Quick facts

Lead sponsorFred Hutchinson Cancer Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1
Start date9 August 2021
Primary completion27 August 2023
Estimated completion27 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival Primary · Up to 730 days post-randomization.

The survival (in days) of subjects in the two arms will be compared using the log-rank test.

GroupValue95% CI
Arm A (alloHCT)730± 0

Sponsor's own description

This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with high-grade myeloid cancers with measurable residual disease. Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before donor stem cell transplantation may help kill cancer cells in the body and make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prognostic and therapeutic implications of measurable residual disease in acute myeloid leukemia.
    Aitken MJL, Ravandi F, Patel KP, Short NJ. · · 2021 · cited 40× · PMID 34479626 · DOI 10.1186/s13045-021-01148-5
  2. Significance of RB Loss in Unlocking Phenotypic Plasticity in Advanced Cancers.
    Venkadakrishnan VB, Yamada Y, Weng K, Idahor O, et al · · 2023 · cited 24× · PMID 37052520 · DOI 10.1158/1541-7786.mcr-23-0045
  3. BMT for Myelodysplastic Syndrome: When and Where and How.
    Jain AG, Elmariah H. · · 2021 · cited 11× · PMID 35070975 · DOI 10.3389/fonc.2021.771614

Verify or expand the search:

Other trials of Allogeneic Hematopoietic Stem Cell Transplantation

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Fred Hutchinson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04526288.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing