Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT00550992
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT00550992
Study Brief:
Protocol Section:
NCT00550992