Status:
TERMINATED
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
Lead Sponsor:
University of Rochester
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
Up to 75 years
Phase:
NA
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer ce...
Detailed Description
OBJECTIVES: * Determine the frequency, extent, and rate of donor (myeloid and lymphoid) engraftment in patients with serious hematologic malignancies treated with nonmyeloablative conditioning regime...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia (AML) with or without history of myelodysplastic syndromes, meeting 1 of the following criteria:
- In first complete remission (CR-1) with unfavorable cytogenetics and/or achieved CR-1 after ≥ 1 course of induction therapy
- Secondary or treatment-related AML
- In second or further complete remission
- Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts
- Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- In CR-1 with unfavorable cytogenetics or elevated WBC at presentation OR failed to achieve CR-1 after ≥ 4 weeks of induction therapy
- In second or further complete remission
- Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts
- Other acute leukemic variants allowed at the discretion of the principal investigator
- Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
- In first chronic phase AND refractory to or unable to tolerate imatinib mesylate
- In second or further chronic phase
- In first or second accelerated phase
- Myelodysplastic syndromes with intermediate 2- or high-risk International Prognosis Scoring System (IPSS) score, including any of the following:
- Refractory anemia
- Refractory anemia with excess blasts
- Chronic myelomonocytic leukemia
- Myeloproliferative disorders with poor prognosis, including any of the following:
- Myelofibrosis with myeloid metaplasia
- No ≥ grade 3 myelofibrosis
- Atypical CML
- Juvenile myelomonocytic leukemia
- Other clonal hemopathies with an accepted poor prognosis
- Multiple myeloma with chromosome 13 abnormalities and/or progression after prior autologous bone marrow transplantation (BMT)
- Chronic lymphocytic leukemia, meeting 1 of the following criteria:
- Primary refractory OR relapsed and refractory disease (less than partial remission)
- Relapsed twice on or after prior chemotherapy
- Lymphoma, meeting both of the following criteria:
- Hodgkin's or non-Hodgkin's lymphoma in \> CR-1 OR failed primary induction
- Chemosensitive disease, defined as \> 50% reduction in mass size after the most recent chemotherapy
- Must meet ≥ 1 of the following criteria:
- Over 45 years of age
- Has undergone prior autologous or allogeneic BMT
- Charlson\^ comorbidity score ≥ 2
- Must have a high degree of tumor control (salvage therapy allowed)
- At high risk for treatment-related mortality with a myeloablative conditioning regimen
- No massive splenomegaly
- Patients may become eligible after splenectomy or radiotherapy to the spleen
- No 5/6 or 6/6 HLA-matched related donor available
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00255684
Start Date
December 1 2003
End Date
June 1 2016
Last Update
November 3 2016
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642