Status:
COMPLETED
Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's ...
Detailed Description
OBJECTIVES: Primary * Determine the clinical efficacy and toxicity profiles of a nonmyeloablative preparative regimen comprising busulfan and fludarabine with or without anti-thymocyte globulin foll...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Chronic lymphocytic leukemia (CLL), meeting the following criteria:
- Absolute lymphocyte count \> 5,000/mm³
- Lymphocytes must appear morphologically mature with \< 55% prolymphocytes
- Lymphocyte phenotype with expression of CD19 and cluster of differentiation 5 (CD5)
- Prolymphocytic leukemia (PLL), meeting the following criteria:
- Absolute lymphocyte count \> 5,000/mm³
- More than 55% prolymphocytes
- Morphologically diagnosed
- Chronic myelogenous leukemia (CML), meeting the following criteria:
- Diagnosis of CML or similar myeloproliferative disorders based on t(9;22) or related t(9;12) cytogenetic abnormalities AND characterized by elevated white blood cell (WBC) counts in peripheral blood or bone marrow
- In first chronic phase CML and a candidate for treatment with reduced-dose busulfan
- Patients with other cytogenetic abnormalities, such as t(9;12), that are associated with an aggressive clinical course are eligible
- Non-Hodgkin's lymphoma (NHL), meeting the following criteria:
- Any World Health Organization (WHO) class histologic subtype allowed
- Core biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping
- Bone marrow biopsies as sole means of diagnosis are not allowed for follicular lymphoma
- Hodgkin's lymphoma, meeting the following criteria:
- Any WHO class histologic subtype allowed
- Core biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping
- Multiple myeloma, meeting the following criteria:
- Active disease requiring treatment (Durie-Salmon stages I, II, or III)
- Acute myeloid leukemia with documented control, defined as \< 10% bone marrow blasts and no circulating blasts
- Acute lymphoblastic leukemia, meeting the following criteria:
- In early first relapse or beyond OR in first complete remission and has 1 of the following high-risk features:
- t(9;22) or t(4;11)
- WBC count \> 30,000/mm³ at presentation
- Non-T-cell phenotype
- More than 30 years of age
- Agnogenic myeloid metaplasia/myelofibrosis
- Patients who are transfusion dependent or who have evolving myelodysplastic or leukemic features or high-risk cytogenetic abnormalities are eligible
- Myelodysplastic syndromes (MDS) as defined by WHO criteria
- Meets 1 of the following criteria:
- Over 55 years of age
- Ineligible for busulfan-based therapy based on diminished organ function or poor performance status
- Indolent and chemotherapy-responsive CLL, low-grade NHL, small lymphocytic lymphoma, or PLL
- Patients who have undergone prior autologous stem cell transplantation are preferentially enrolled on clinical trial CALGB-100002, if available and patient is eligible
- HLA-matched or mismatched related donor or HLA-matched unrelated donor available
- HLA-identical sibling (6/6 or 9/10) (minimal serologic typing required for class I \[A, B\]; molecular typing required for class II (DRB1))
- 9/10 matched unrelated donor (MUD) (molecular analysis at HLA A, B, C, DRB1, and DQB1 by high resolution typing required)
- 5/6 MUD (molecular analysis at HLA A, B, and DRB1 required)
- No syngeneic donors
- PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) ≤ 3 times ULN
- Diffusing capacity of the lungs for carbon monoxide (DLCO) \> 40% with no symptomatic pulmonary disease
- Left ventricular ejection fraction (LVEF) ≥ 30% by multigated acquisition scan (MUGA)
- No uncontrolled diabetes mellitus or active serious infection
- No known hypersensitivity to Escherichia coli-derived products
- No HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy, radiotherapy (except prophylactic cranial x-ray therapy), or surgery
Exclusion
Key Trial Info
Start Date :
January 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00448201
Start Date
January 7 2011
End Date
May 23 2012
Last Update
May 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295