N/A
N=10
AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
Leukemia · Lymphoma · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00547196 ↗Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Apr 2023
Primary outcome: Primary: Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB) — 100; 100; 100 percentage of surviving patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- filgrastim (Biological); Busulfan (Drug); Cyclophosphamide (Drug); Cyclosporine (Drug); Fludarabine phosphate (Drug); Melphalan (Drug); Mycophenolate Mofetil (Drug); allogeneic hematopoietic stem cell transplantation (Procedure); umbilical cord blood transplantation (Procedure); total-body irradiation (Radiation); Fractionated total body irradiation (Radiation)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
100; 100; 100 | — |
| SECONDARY Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB) |
60; 100; 50 | — |
Summary
RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed hematological or lymphatic malignancy, including any of the following:
- Acute myeloid leukemia
- Relapsed or primary refractory disease with 40%
- FEV1, FVC, or DLCO 3 mg/dL
- Creatinine > 2 mg/dL
- Two partially HLA-matched umbilical cord blood (UCB) units available
- HLA-matched minimally at 4 of 6 HLA-A, HLA-B, and -DRB1 loci with the patient
- DRB1 matched by high resolution DNA typing
- HLA-A and HLA-B matched by low resolution at the "serological match" level
- Two pooled units with a nucleated cell number > 2.5 x 10^7/kg
- No available HLA-identical sibling or 1 antigen-mismatched related donor
- No available HLA-matched unrelated bone marrow donor
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Karnofsky performance status (PS) 60-100% OR Lansky PS 60-100% OR Zubrod PS 0-1
- Physiological age 60 or less (at any chronological age)
- Weight > 50 kg
- Creatinine normal for age OR creatinine clearance by 24-hour urine collection or glomerular filtration rate > 60 mL/min
- Bilirubin ≤ 1.5 mg/dL
- LVEF ≥ 50%
- DLCO ≥ 60% of predicted
- No HIV-1 infection
- No active uncontrolled infection
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Recovered from prior intensive chemotherapy
Data sourced from ClinicalTrials.gov (NCT00547196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.