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Total Body Irradiation, Thiotepa, and Fludarabine Followed By A Donor Peripheral Blood Stem Cell Transplant in Treating Young Patients With Hematologic Cancer - Article


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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.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES: Primary

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:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00112567


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98104,  United States; Recruiting
Ann Woolfrey, MD  206-667-4453 

Study chairs or principal investigators

Ann Woolfrey, MD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000430650; FHCRC-1629.00
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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October 11, 2008



Page Updated: June 1, 2005
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