Status:
COMPLETED
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility (i.e., risk of treatment-related mortality during the first 6 months after transplantation) of administering reduced-intensity allogeneic hematopoieti...
Eligibility Criteria
Inclusion
- Histologically confirmed hematological disease, including any of the following:
- Chronic lymphocytic leukemia
- Absolute lymphocytosis \> 5,000/µL
- Morphologically mature lymphocytes with \< 55% prolymphocytes
- Lymphocyte phenotype with expression of CD19 and CD5
- Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma
- Prolymphocytic leukemia
- Absolute lymphocytosis \> 5,000/µL
- Morphologically mature lymphocytes with \> 55% prolymphocytes
- Non-Hodgkin's or Hodgkin's lymphoma
- Any WHO classification histologic subtype
- Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping
- Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas
- Multiple myeloma
- Has received ≥ 1 prior treatment regimen
- Has a partial response or greater by the Blade Criteria
- Patients who achieved complete remission are eligible
- Acute myeloid leukemia
- Documented control (i.e., \< 10% bone marrow blasts and no circulating blasts)
- Myelodysplastic syndromes
- Documented disease as defined by WHO or French-American-British Cooperative group criteria
- Chronic myelogenous leukemia
- Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible
- Polycythemia vera
- Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
- A1: Total red blood cell mass \> 25% above mean normal predicted value OR hemoglobin \> 18.5 g/dL in males, 16.5 g/dL in females (hematocrit ≥ 60% in males or ≥ 56% in females)
- A2: No cause of secondary erythrocytosis (absence of familial erythrocytosis, no elevation of epoetin alfa \[EPO\] due to hypoxia, high oxygen affinity hemoglobin, truncated EPO receptor, or inappropriate ectopic EPO production)
- A3: Splenomegaly
- A4: Clonal genetic abnormality other than the Philadelphia chromosome
- A5: Endogenous erythroid colony formation in vitro
- B: Platelet count \> 400,000/mm³, WBC \> 12,000/mm³, bone marrow biopsy with prominent erythroid and megakaryocytic proliferation, and low serum EPO
- Chronic idiopathic myelofibrosis
- Documented disease as defined by WHO criteria
- Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria:
- HLA-identical sibling (6/6)
- Serologic typing for class I (A, B)
- Molecular typing for class II (DRB1)
- 9/10 matched related donor
- High-resolution molecular typing at HLA-A, B, C, DRB1, and DQB1
- Only a single mismatch at one class I or II allele allowed
- 10/10 matched unrelated donor
- Molecular identity at HLA-A, B, C, DRB1, and DQB1 by high-resolution typing
- Syngeneic donors are not eligible
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- DLCO ≥ 40% with no symptomatic pulmonary disease
- LVEF ≥ 30% by cardiac MRI or echocardiogram with no symptomatic cardiac disease
- Fertile patients willing to use effective contraception
Exclusion
- Uncontrolled diabetes mellitus
- Active serious infection
- Known hypersensitivity to E. coli-derived products
- Known HIV positivity
- History of another malignancy\*, meeting the following criteria:
- Non-skin malignancy or melanoma within the past 5 years
- Concomitant malignancy that has not been curatively treated
- NOTE: \*However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of \< 30% for recurrence by their treating physicians is considered
- Pregnant or nursing
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00453206
Start Date
February 1 2007
End Date
August 1 2014
Last Update
September 10 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096