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Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 85% 435 → 66 participants
See other at-risk trials from Children's Oncology Group

Record History

  1. Enrollment reduced: 435 → 66 participants Completion pushed from Jun 30, 2026 to Jul 7, 2027v30 Show 1 more changeShow less
    • Completion pushed from Jun 30, 2026 to Jul 7, 2027
  2. Re-verified, no change to tracked fieldsv29
  3. Study sites revised (63)v28 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (63)v27 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv26
Show 24 earlier versionsHide 24 earlier versions
  1. Primary and study completion dates: Dec 1, 2027 to Jun 30, 2026 Trial status: Recruiting to Active, Not Recruiting · Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography Test… · Site details revised at 63 of 63 sitesv25 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography Test…
    • Site details revised at 63 of 63 sites
  2. Site details revised at 5 of 63 sitesv24
  3. Study sites: 62 to 63v23
  4. Site details revised at 2 of 62 sitesv22
  5. Site contacts updated at 1 of 62 sitesv21
  6. Site details revised at 2 of 62 sitesv20
  7. Site details revised at 1 of 62 sitesv19
  8. Study sites: 56 to 62v18
  9. Study sites: 55 to 56v17
  10. Secondary endpoints: details revised at 1 of 3 entriesv16
  11. Primary endpoints revised (2) Study sites: 51 to 55 · Eligibility criteria expanded, about 179 words · Study description expanded, about 62 wordsv15 Show 3 more changesShow less
    • Study sites: 51 to 55
    • Eligibility criteria expanded, about 179 words
    • Study description expanded, about 62 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 47 to 51v14
  13. Start date: Nov 21, 2022 to Mar 15, 2023v13
  14. Study sites: 34 to 47v12
  15. Study sites: 31 to 34v11
  16. Study sites: 16 to 31v10
  17. Study sites: 9 to 16v9
  18. Primary endpoints revised (2) Study sites: 8 to 9 · Secondary endpoints: details revised at 3 of 3 entries · Study description expanded, about 19 wordsv8 Show 3 more changesShow less
    • Study sites: 8 to 9
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 7 to 8v7
  20. Study sites: 3 to 7 Interventions: Busulfan (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Haploidentical Hematopoietic Cell Transplantation (Procedure), Lapine… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography… · Eligibility criteria revised · Study description expanded, about 28 wordsv6 Show 3 more changesShow less
    • Interventions: Busulfan (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Haploidentical Hematopoietic Cell Transplantation (Procedure), Lapine… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Busulfan (Drug), Cyclophosphamide (Drug), Echocardiography…
    • Eligibility criteria revised
    • Study description expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 2 to 3v5
  22. Study sites: 1 to 2v4
  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 23, 2022 to Nov 21, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 23, 2022 to Nov 21, 2022
  24. Start date: Aug 26, 2022 to Nov 23, 2022 Primary endpoints revised (2) · Enrollment target: 336 to 435 · Interventions: Haploidentical hematopoietic cell transplantation (haploHCT) (Procedure), matched unrelated donor hematopoietic cell transplantation… to Busulfan (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Haploidentical Hematopoietic Cell Transplantation (Procedure), Lapine… · 5 morev2 Show 8 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 336 to 435
    • Interventions: Haploidentical hematopoietic cell transplantation (haploHCT) (Procedure), matched unrelated donor hematopoietic cell transplantation… to Busulfan (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Haploidentical Hematopoietic Cell Transplantation (Procedure), Lapine…
    • Eligibility criteria expanded, about 1,477 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 409 words
    • Collaborators shortened, about 4 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.
Trial Details
NCT Number NCT05457556
Lead Sponsor Children's Oncology Group
Conditions Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov