Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant - NCT00354419-98104(Clinical Trial 146829)
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Seattle |
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State:
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WA |
| Zip Code: |
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98104 |
| Conditions: |
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Nonmalignant Neoplasm |
| Purpose: |
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RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord
blood stem cell transplant helps stop the growth of abnormal cells. It also helps stop the
patient's immune system from rejecting the donor's stem cells. When the healthy 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 phase I/II trial is studying the side effects and best dose of total-body
irradiation when given together with cyclophosphamide and antithymocyte globulin in treating
patients with severe aplastic anemia undergoing umbilical cord blood transplant.
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| Study summary: |
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OBJECTIVES:
- Determine the lowest dose of total-body irradiation combined with cyclophosphamide and
antithymocyte globulin that will achieve sustained engraftment in patients with severe
aplastic anemia undergoing related or unrelated umbilical cord blood transplantation.
OUTLINE: This is a prospective, dose-finding study of total-body irradiation (TBI).
- Myeloablative conditioning regimen: Patients receive cyclophosphamide IV on days -7 to
-4, -6 to -3, or -5 to -2 and anti-thymocyte globulin IV on days -6 to -4, -5 to -3, or
-4 to -2.
- TBI: Patients undergo TBI twice daily on days -3, -2, and/or -1. Cohorts of 6 patients
receive escalating or de-escalating doses of TBI until the optimal dose is determined.
The optimal dose is defined as the dose at which ≤ 2 of 6 or 3 of 12 patients
experience dose-limiting toxicity and ≤ 1 of 6 or 1 of 12 patients fail to engraft.
- Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0. Patients
receive filgrastim (G-CSF) IV or subcutaneously beginning on day 1 and continuing until
blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally
(twice daily for patients ≥ 6 years of age or 3 times daily for patients < 6 years of
age) on days -1 to 180 and mycophenolate mofetil IV or orally (twice daily for patients
≥ 50 kg or 3 times daily for patients < 50 kg) beginning 4 hours after UCBT and
continuing until approximately day 30.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant
etiology meeting 2 of the following criteria:
- Granulocyte count < 500/mm³
- Corrected reticulocyte count < 1%
- Platelet count < 20,000/mm³
- Failed to respond to the best available immunosuppressive treatment protocol by 75
days after initiation of therapy
- No paroxysmal nocturnal hemoglobinuria or Fanconi's anemia
- No clonal cytogenetic abnormalities or myelodysplastic syndromes
- No HLA-identical family member or closely matched (9 or 10 of 10 HLA-locus match)
unrelated marrow donor available
- Umbilical cord blood (UCB) donor available
- Unrelated UCB donor matched for ≥ 4 of 6 loci or related UCB donor matched for ≥
3 of 6 loci at the HLA-A and -B antigen level and DRB1 allele level
- If multiple units are selected, the following criteria apply:
- The UCB units must be matched to each other for ≥ 4 of 6 loci
- Each unit must contain ≥ 1.5 x 10^7 total nucleated cells (TNC) per kg
recipient weight
PATIENT CHARACTERISTICS:
- No active fungal infections
- HIV negative
- No severe disease other than aplastic anemia that would severely limit the
probability of survival during the graft procedure
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent aspirin or nonsteroidal anti-inflammatory drugs |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 22, 2010 |
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