Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer
NCT ID: NCT00296023
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
1999-01-31
2008-06-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
Detailed Description
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Primary
* Determine the safety of non-myeloablative allogeneic peripheral blood stem cell transplantation, in terms of regimen-related organ toxicity and toxicity from acute graft-vs-host disease (GVHD), in older or medically frail patients with high-risk indolent hematologic malignancies.
* Determine overall survival, disease-free survival, and relapse risk at 1, 2, and 3 years post-transplantation in these patients.
Secondary
* Determine the engraftment of donor hematopoiesis at 6 weeks, 3 and 6 months, and 1 year post-transplantation in these patients.
* Determine the incidence and severity of chronic GVHD in older and medically infirm patients treated with this regimen.
* Determine the safety and efficacy of collecting peripheral blood stem cells from older donors (age \> 60 years).
* Determine the need and efficacy of donor lymphocyte infusions in patients with residual disease after transplant.
OUTLINE:
* Non-myeloablative preparative regimen:Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours every 8 hours on days -4 and -3, and anti-thymocyte globulin IV over 8 hours on days -4 to -1.
* Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover.
* Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally every 12 hours or IV continuously beginning on day -2 and continuing until day 90, followed by a taper until day 180. Patients also receive methotrexate IV over 15-30 minutes on days 1, 3, 6, and 11.
* Donor lymphocyte infusions (DLIs): Patients with residual disease ≥ 6 months post-transplantation who are off immunosuppression for ≥ 30 days with no evidence of GVHD may receive DLIs. DLIs are administered ≥ 12 weeks apart in the presence of persistent disease, absence of severe (grade 3-4) GVHD, and absence of persistent GVHD after the first DLI.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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stem cell transplant
anti-thymocyte globulin
filgrastim
therapeutic allogeneic lymphocytes
busulfan
fludarabine phosphate
methotrexate
tacrolimus
nonmyeloablative allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Interventions
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anti-thymocyte globulin
filgrastim
therapeutic allogeneic lymphocytes
busulfan
fludarabine phosphate
methotrexate
tacrolimus
nonmyeloablative allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Age 60 to 75 years old AND no co-morbid illness
* Younger patients with any of the following comorbidities:
* Decreased cardiac ejection fraction
* Pulmonary dysfunction
* Elevated liver function tests
* Hepatitis C infection
* Poor performance status
* Sibling or related donor available
* Matched ≥ 5/6 HLA loci (A, B, and DR) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* ECOG performance status 0-2
* Creatinine \< 2.0 mg/dL
* Creatinine clearance \> 40 mL/min
* Ejection fraction \> 30% by echocardiogram or MUGA
* Bilirubin \< 3.0 mg/dL (if total bilirubin is elevated and Gilbert's disease is suspected, direct bilirubin must be normal)
* Alkaline phosphatase \< 4 times ULN
* AST \< 4 times ULN
* HIV negative
* Hepatitis B and/or C virus allowed if a liver biopsy (performed within the past 3 months) shows ≤ grade 2 inflammation
* No active infection
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Thomas G. Martin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Willis Navarro, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Charles A. Linker, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-98251
Identifier Type: -
Identifier Source: secondary_id
UCSF-9805
Identifier Type: -
Identifier Source: secondary_id
UCSF-H9996-15837-06
Identifier Type: -
Identifier Source: secondary_id
CDR0000463724
Identifier Type: -
Identifier Source: org_study_id