- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112567
Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.
PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-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.
- CD34-positive (CD34+)-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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109-1023
- Seattle Cancer Care Alliance
-
Seattle, Washington, United States, 98104
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
Secondary Outcome Measures
Outcome Measure |
---|
Kinetics of immune reconstitution
|
Risk of severe graft-versus-host disease
|
Risk of life-threatening infections
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann E. Woolfrey, MD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- recurrent childhood acute lymphoblastic leukemia
- accelerated phase chronic myelogenous leukemia
- recurrent childhood acute myeloid leukemia
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Preleukemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Fludarabine
- Fludarabine phosphate
- Thiotepa
Other Study ID Numbers
- 1629.00
- FHCRC-1629.00
- CDR0000430650 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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