Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
NCT ID: NCT00301951
Last Updated: 2017-10-12
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
PHASE1
7 participants
INTERVENTIONAL
2004-09-30
2009-07-31
Brief Summary
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PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
Detailed Description
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Primary
* Assess the feasibility of performing umbilical cord blood transplants in older patients or younger infirm patients with advanced hematologic malignancies using a reduced-intensity preparative regimen, as determined by \> 80% engraftment rate at day 180 and a \< 50% transplant-related mortality rate at day 100.
Secondary
* Describe the time to neutrophil and platelet recovery in patients treated with this regimen.
* Determine disease-specific, event-free, and overall survival rate at days 180 and 360.
* Determine the incidence, severity, and timing of acute and chronic graft-versus-host disease in patients treated with this regimen.
* Evaluate T-cell, B-cell, and natural killer cell recovery in patients treated with this regimen.
* Assess lineage-specific chimerism after transplantation and describe the contribution of each individual cord blood unit to post-transplantation hematopoiesis.
OUTLINE: This is a pilot study.
* Reduced-intensity preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4, busulfan IV over 2 hours 4 times daily on days -4 and -3, and anti-thymocyte globulin IV over 6 hours on days -3 to -1.
* Allogeneic umbilical cord blood transplantation: Patients undergo allogeneic umbilical cord blood transplant on day 0. Patients receive sargramostim (GM-CSF) subcutaneously or IV beginning on day 7 and continuing until blood counts recover.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally (as tolerated) beginning on day -2 and continuing for approximately 9 months. Patients also receive oral mycophenolate mofetil twice daily on days 1-50.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cord blood transplant
anti-thymocyte globulin
sargramostim
busulfan
fludarabine phosphate
mycophenolate mofetil
tacrolimus
umbilical cord blood transplantation
Interventions
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anti-thymocyte globulin
sargramostim
busulfan
fludarabine phosphate
mycophenolate mofetil
tacrolimus
umbilical cord blood transplantation
Eligibility Criteria
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Inclusion Criteria
* Follicular large cell
* Mantle cell
* Peripheral T-cell
* T-natural killer (T-NK) cell
* Hodgkin's lymphoma
* Must have progressed, recurred after prior therapy, or failed to respond to primary therapy
* Relapsed disease after autologous stem cell transplantation (SCT) allowed
* Low-grade non-Hodgkin's lymphoma meeting 1 of the following criteria:
* Relapsed or refractory disease after ≥ 2 chemotherapy-based treatment regimens
* Relapsed after autologous SCT
* Chronic lymphocytic leukemia
* Relapsed or refractory disease after ≥ 2 chemotherapy-based treatment regimens
* Relapsed after autologous SCT
* Meets 1 of the following criteria:
* Age 55-70 years
* Under age 55 and deemed ineligible for conventional high-dose chemotherapy, as indicated by any of the following:
* Poor cardiac function (i.e., LVEF \< 40%)
* Poor pulmonary function (i.e., DLCO \< 50%)
* Hepatic dysfunction
* Prior myeloablative therapy
* Not eligible for autologous SCT or conventional therapy
* Umbilical cord blood donor available
* Matched at ≥ 4 of 6 HLA antigens (A, B, and DR)
* Has 1-3 units of umbilical cord blood available
* Must not have an HLA-identical or 1 antigen mismatched related donor or potential HLA-matched unrelated donor readily available 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:
* ECOG performance status 0-2
* Creatinine clearance \> 40 mL/min
* Creatinine \< 2.0 mg/dL
* AST and alkaline phosphatase \< 3 times upper limit of normal (ULN)
* Bilirubin \< 2.0 mg/dL
* Hepatitis C or active hepatitis B virus (HBV) allowed if ≤ grade 2 fibrosis and/or inflammation by liver biopsy
* Patients with history of HBV infection should be tested for hepatitis B epsilon (HBe) antigen, anti-HBe, and HBV DNA (quantitative)
* Patients with active HBV viral replication should receive antiviral therapy
* Ejection fraction \> 30%
* DLCO ≥ 40%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring ongoing antibiotic treatment
* HIV negative
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
70 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
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-04253
Identifier Type: -
Identifier Source: secondary_id
UCSF-2407
Identifier Type: -
Identifier Source: secondary_id
UCSF-H24045-25271-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000465362
Identifier Type: -
Identifier Source: org_study_id