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NCT04232241

Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Active, enrolled Phase 2 Last updated 22 April 2025
What this trial tests

Phase 2 trial testing Allogeneic Stem Cell Transplantation in Acute Myeloid Leukemia in Remission in 167 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
14 November 2019
Primary endpoint
22 November 2026
26 November 2026

Quick facts

Lead sponsorUniversitätsklinikum Hamburg-Eppendorf
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment167
Start date14 November 2019
Primary completion22 November 2026
Estimated completion26 November 2026
Sites24 locations across Italy, Finland, Russia, Austria, Germany, Spain, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

Adults 18 to 70, any sex, with Acute Myeloid Leukemia in Remission or Acute Lymphoblastic Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anti-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA matched unrelated donor and a haploidentical donor. The hypothesis: Haploidentical stem cell transplantation with post cyclophosphamide induces a stronger anti-leukemic activity in comparison to 10/10 HLA matched unrelated donor and reduces the risk of relapse at 2 years after stem cell transplantation by 10%.

Publications & conference data

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

  1. Post-transplant cyclophosphamide containing regimens after matched sibling, matched unrelated and haploidentical donor transplants in patients with acute lymphoblastic leukemia in first complete remission, a comparative study of the ALWP of the EBMT.
    Sanz J, Galimard JE, Labopin M, Afanasyev B, et al · · 2021 · cited 39× · PMID 34049582 · DOI 10.1186/s13045-021-01094-2
  2. Haploidentical Stem Cell Transplantation for Acute Myeloid Leukemia: Current Therapies, Challenges and Future Prospective.
    Chang YJ, Zhao XY, Huang XJ. · · 2021 · cited 15× · PMID 34778077 · DOI 10.3389/fonc.2021.758512
  3. Effective Immunosurveillance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia.
    Kunadt D, Stölzel F. · · 2021 · cited 3× · PMID 34594134 · DOI 10.2147/cmar.s261721
  4. The EHA Research Roadmap: Hematopoietic Stem Cells and Allotransplantation.
    Fibbe W, Bernardi R, Charbord P, Krause D, et al · · 2022 · cited 1× · PMID 35509429 · DOI 10.1097/hs9.0000000000000714

Verify or expand the search:

Other trials of Allogeneic Stem Cell Transplantation

Trials testing the same drug.

Other recruiting trials for Acute Myeloid Leukemia in Remission

Currently open trials in the same condition.

Other Universitätsklinikum Hamburg-Eppendorf trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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