Fludarabine Phosphate |
Fludara |
Clinical Trial: Total Body Irradiation, Thiotepa, and Fludarabine Followed By A Donor Peripheral Blood Stem Cell Transplant in Treating Young Patients With Hematologic Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body''''s normal cells. Total-body irradiation, fludarabine, and thiotepa before transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa given before a donor peripheral blood stem cell transplant and to see how well it works in treating young patients with hematologic cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| childhood acute lymphoblastic leukemia childhood acute myeloid leukemia and other myeloid malignancies Chronic Myelogenous Leukemia secondary acute myeloid leukemia | Drug: fludarabine Drug: thiotepa Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy | Phase I Phase II |
MedlinePlus related topics: Bone Marrow Diseases; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Conditioning Regimen Comprising Total Body Irradiation, Thiotepa, and Fludarabine Followed By CD 34-Positive-Selected Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Young Patients With Life-Threatening Hematologic Malignancies
OBJECTIVES: Primary
- Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD 34-positive-selected haploidentical allogeneic peripheral blood stem cell transplantation in young patients with life-threatening hematologic malignancies.
Secondary
- Determine the risk for severe graft-vs-host disease in patients treated with this regimen.
- Determine the kinetics of immune reconstitution in patients treated with this regimen.
- Determine the risk for life-threatening infections in patients treated with this regimen.
OUTLINE:
- Conditioning regimen: Patients 7 years of age and under undergo total body irradiation twice daily on days -9 to -7. Patients over 7 years of age undergo total body irradiation once on day -7. All patients receive fludarabine IV once daily on days -6 to -2 and thiotepa IV over 2 hours twice on day -5.
- CD 34-positive (CD 34+)-selected haploidentical allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and 2. Patients with acute lymphoblastic leukemia or CNS disease also receive methotrexate intrathecally twice before transplantation and 4 times after day 35 post-transplantation. Male patients with lymphoid malignancies undergo additional radiotherapy to the testes.
After completion of study treatment, patients are followed for at least 100 days, at 1 year, and then periodically thereafter.
PROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients > 7 years of age) will be accrued for this study within 3 years.
Eligibility
Ages Eligible for Study: up to 20 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a life-threatening hematologic malignancy, including any of the following:
- Acute leukemia advanced beyond first remission
- Acute leukemia in first remission* with very high-risk prognostic features, including any of the following:
- Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL)
- ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality
- Hypodiploid ALL
- Failed to achieve first remission within 1 month after induction therapy
- Secondary AML
- Myelodysplastic syndromes with International Prognostic Index score > 1
- Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be approved by PCC
- Haploidentical family donor available
- No suitable HLA-matched related or unrelated donor available
- No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available
PATIENT CHARACTERISTICS: Age
- Under 21
Performance status
- Not specified
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- SGPT and SGOT < 2 times upper limit of normal (ULN)*
- Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy
Renal
- Not specified
Cardiovascular
- Ejection fraction ≥ 45%
Pulmonary
- DLCO ≥ 60% of predicted
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy
- No second bone marrow transplantation, after a first regimen containing total body irradiation
- No concurrent growth factors until day 21 post-transplantation
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Biologic therapy
Surgery
- Not specified
Location and Contact Information
Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98104, United States; Recruiting
Ann Woolfrey, MD, Principal Investigator, Fred Hutchinson Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Record last reviewed: May 2005
Last Updated: June 2, 2005
Record first received: June 2, 2005
ClinicalTrials.gov Identifier: NCT00112567
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07

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