Different Therapies in Treating Infants With Newly Diagnosed Acute Leukemia

Status: Recruiting
Phase: N/A
Diagnosis: Pediatric Leukemia
NCT ID: NCT00550992 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-172


RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia. PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Lewis Silverman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: Inclusion criteria: - Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria: - Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria - Newly diagnosed disease - Verified by morphology and confirmed by cytochemistry and immunophenotyping - Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap" - Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria: - Low-risk disease, defined as all MLL germline cases - Medium-risk disease, defined by 1 of the following criteria: - MLL status unknown - MLL rearranged AND age > 6 months - MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response - High-risk disease, defined by MLL rearrangement AND meets the following criteria: - Age at diagnosis < 6 months (i.e., < 183 days) - WBC ≥ 300 x 10^9/L AND/OR prednisone poor response - Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation: - Donor meeting 1 of the following criteria: - HLA-identical sibling - Very well-matched related or unrelated donor - Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping - Stem cell source - Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim [G-CSF]-stimulated donors OR cord blood - Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10^7/kg recipient body weight [BW]) is cryopreserved - Must have ≥ 3 x 10^8 NCs/kg BW OR 3 x 10^6/kg BW CD34-positive cells available for transplantation - CNS or testicular leukemia at diagnosis allowed Exclusion criteria: - Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL - Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible) - Relapsed ALL PATIENT CHARACTERISTICS: - See Disease Characteristics PRIOR CONCURRENT THERAPY: - More than 4 weeks since prior systemic corticosteroids - Corticosteroids by aerosol are allowed
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