Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer
NCT ID: NCT00255684
Last Updated: 2016-11-03
Study Results
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View full resultsBasic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2003-12-31
2016-06-30
Brief Summary
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PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor umbilical cord blood transplant for hematologic cancer.
Detailed Description
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* Determine the frequency, extent, and rate of donor (myeloid and lymphoid) engraftment in patients with serious hematologic malignancies treated with nonmyeloablative conditioning regimen comprising fludarabine, cyclophosphamide, and low-dose total-body irradiation followed by unrelated allogeneic umbilical cord blood transplantation and post-transplant immunosuppression comprising cyclosporine and mycophenolate mofetil.
* Correlate clinical and umbilical cord blood-related factors with engraftment in patients treated with this regimen.
* Determine transplant-related complications, in terms of toxicity, myelosuppression, infections, and acute and chronic graft-versus-host disease, in patients treated with this regimen.
* Determine disease-free and overall survival of patients treated with this regimen.
* Determine treatment-related mortality of patients treated with this regimen.
OUTLINE: This is a uncontrolled, pilot study.
* Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes daily on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6 and undergo low-dose total-body irradiation (TBI) on day 0.
* Unrelated allogeneic umbilical cord blood transplantation (UCBT): After completion of TBI, patients undergo 1 or 2 unrelated allogeneic UCBTs on day 0.
* Post-transplant immunosuppression: Patients receive oral or IV cyclosporine daily beginning on day -3 and continuing until day 180 and oral or IV mycophenolate mofetil twice daily on days 0-30.
Patients are followed periodically for 1 year after transplantation.
PROJECTED ACCRUAL: A total of 20 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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Conditioning therapy followed by TBI
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor induction therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
Interventions
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graft-versus-tumor induction therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* No well-matched (i.e., ≥ 9/10 HLA match by high-resolution typing) unrelated donor available
PATIENT CHARACTERISTICS:
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 4 times ULN (unless due to underlying disease)
Renal
* Creatinine clearance ≥ 50 mL/min
Cardiovascular
* Ejection fraction ≥ 30%
Pulmonary
* DCLO ≥ 35%
Other
* Negative pregnancy test
* No uncontrolled viral, bacterial, or fungal infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Radiotherapy
* See Disease Characteristics
Other
* At least 3 months since prior immunosuppressive therapy
* At least 10 days since prior salvage therapy for patients not in at least morphologic or radiologic complete remission
75 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Principal Investigators
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Gordon L. Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
James P. Wilmot Cancer Center
Locations
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James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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URCC-U19403
Identifier Type: -
Identifier Source: secondary_id
URCC-RSRB-10063
Identifier Type: -
Identifier Source: secondary_id
CDR0000448637
Identifier Type: -
Identifier Source: org_study_id