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NCT03494569

Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic Syndrome

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 18 versions: 14 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Suspended → Active, Not Recruiting
    • Enrollment increased: 36 → 54 participants
  2. Primary and study completion dates: Sep 8, 2026 to Sep 7, 2027
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 7 of 13 entries
  3. Primary and study completion dates: Jun 11, 2026 to Sep 8, 2026v16
  4. Trial status: Recruiting to Suspended Sponsor's reason: Accrual goal
    • Primary and study completion dates: Sep 8, 2026 to Jun 11, 2026
    • Site details revised
    v15
  5. Primary and study completion dates: Oct 11, 2025 to Sep 8, 2026v14
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Nov 11, 2028 to Oct 11, 2025v13
  2. Primary and study completion dates: Dec 25, 2023 to Nov 11, 2028v12
  3. Primary and study completion dates: Dec 2021 to Dec 25, 2023v10
  4. Primary and study completion dates: Jul 2020 to Dec 2021v9
  5. Eligibility criteria expanded, about 3 wordsv7
  6. Primary and study completion dates: Sep 2020 to Jul 2020
    • Start date changed from estimate of Sep 16, 2018 to Jul 6, 2018
    v5
  7. Eligibility criteria shortened, about 22 wordsv3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of toxicity
Timeframe: Up to 2 years

Secondary (13)

Overall survival
Event-free survival
Relapse/progression
Complete remission proportion
Non-relapse mortality
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Incidence of infection
Incidence of toxicities/adverse events (AEs)
Neutrophil recovery
Acute graft versus host disease of grades 2-4 and 3-4
Chronic graft versus host disease
CD4+, CD8+ and CD56+16+
Bone marrow (BM) residual damage
Immune reconstitution

Arms and interventions

Treatment (TMLI, fludarabine, melphalan)Experimental

Participants undergo TMLI BID on days -8 to -5, and receive fludarabine IV on days -4 to -2 and melphalan on day -2. Participants then undergo alloHCT on day 0.

Drugs: Fludarabine, Melphalan

Other: Laboratory Biomarker Analysis

Radiation: Total Marrow Irradiation

Sites

1 site in 1 country

  • City of Hope Medical CenterDuarte, California, United States