AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
NCT ID: NCT00547196
Last Updated: 2024-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2005-08-16
2024-05-28
Brief Summary
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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.
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Detailed Description
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Primary
* To determine the survival at day 100 of patients with relapsed, refractory, or poor-risk hematological malignancies treated with four different preparative regimens followed by allogeneic hematopoietic stem cell transplantation (HSCT) using two unrelated umbilical cord blood (UCB) units.
Secondary
* To determine the incidence and timing of neutrophil engraftment in patients treated with these regimens.
* To determine the incidence and timing of platelet engraftment in patients treated with these regimens.
* To determine the incidence and severity of acute and chronic graft-versus-host-disease (GVHD) in patients treated with these regimens.
* To determine the survival at day 180 in patients treated with these regimens.
* To determine the disease-free survival in patients treated with these regimens.
* To determine the incidence of primary and secondary engraftment failure in patients treated with these regimens.
* To determine the incidence of transplantation-related complications (e.g., infection, veno-occlusive disease of the liver, or organ toxicity) in these patients.
* To determine the incidence of post-transplantation-related lymphoproliferative disease, secondary myelodysplastic syndromes, or other secondary malignancies in these patients.
* To determine the incidence of relapse in patients treated with these regimens.
* To determine post-transplantation chimerism in patients treated with these regimens.
* To determine immune reconstitution in patients treated with these regimens.
OUTLINE: This is a multicenter study.
* Preparative regimens: Patients are assigned to 1 of 4 preparative regimens.
* Regimen 1 (for patients \< 50 years of age and no contraindication to fractionated total-body irradiation (FTBI): Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2.
* Regimen 2 (for patients \< 50 years of age and unable to tolerate FTBI due to prior dose-limiting radiotherapy or significant cardiotoxicity): Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2.
* Regimen 3\* (for patients unable to tolerate regimen 1 or 2; no age exclusion): Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2.
* Regimen 4\* (for patients unable to tolerate regimen 1 or 2): Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2.
NOTE: \*Treating physician decides the choice between regimen 3 and 4
* Umbilical cord blood (UCB) transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover.
* Graft-versus-host-disease prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
After completion of study therapy, patients are followed periodically.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen I (FTBI, Cyclophosphamide, Fludarabine)
Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
filgrastim
Cyclophosphamide
Cyclosporine
Fludarabine phosphate
Mycophenolate Mofetil
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Fractionated total body irradiation
Regimen II (Busulfan, Fludarabine, Melphalan)
Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
filgrastim
Busulfan
Cyclosporine
Fludarabine phosphate
Melphalan
Mycophenolate Mofetil
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Regimen III (TBI, Cyclophosphamide, Fludarabine)
Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
filgrastim
Cyclophosphamide
Cyclosporine
Fludarabine phosphate
Mycophenolate Mofetil
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
total-body irradiation
Regimen IV (Fludarabine, Melphalan)
Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated).
filgrastim
Cyclosporine
Fludarabine phosphate
Melphalan
Mycophenolate Mofetil
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Interventions
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filgrastim
Busulfan
Cyclophosphamide
Cyclosporine
Fludarabine phosphate
Melphalan
Mycophenolate Mofetil
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
total-body irradiation
Fractionated total body irradiation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FEV1, FVC, or DLCO \< 50%
* Bilirubin \> 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
0 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anna Pawlowska, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-02165
Identifier Type: -
Identifier Source: secondary_id
CDR0000570249
Identifier Type: REGISTRY
Identifier Source: secondary_id
02165
Identifier Type: -
Identifier Source: org_study_id
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