The purpose of the study is to find out whether the combination of chemotherapy drugs that are routinely used in children with ALL, will be safe and effective in treating adult patients with ALL. The standard treatment for adults with ALL consists of many chemotherapy drugs that are given in different combinations and in several steps. In adult ALL there is no standard which drugs to give and how to combine them. Some leukemias have a chromosome abnormality called Philadelphia chromosome (also called Ph Positive) and some leukemias do not (called Ph Negative). In this study we want to see whether this combination of chemotherapy drugs will be safe and effective in treating adult patients with Ph Negative ALL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.
PET or CT scan every 6 months for 3 years
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
rate of molecular remission
i.e. minimal residual disease (MRD) negative status, as assessed by PCR and flow cytometry in the bone marrow after phase I induction.
Time frame: 1 year
complete remission (CR)
All three criteria must be met for clinical complete remission: * Peripheral Blood Counts. The absolute neutrophil count should be ≥1,000/μl (sustained without growth factor support), and platelet count should be ≥100,000/μl (without transfusions), and no circulating blasts. After Induction remission assessment, blood counts are considered recovered at ANC ≥ 1,000 and PLT ≥75,000. * Bone Marrow Aspirate. Bone marrow cellularity should be approximate normal with evidence of maturation of all cell lineages and should contain \<5% blasts. * Extramedullary Leukemia, such as CNS or soft tissue involvement, must not be present. If the patient had CNS involvement by ALL at the time of starting the study, the CNS involvement should be re-examined and interval determined by the treating physicians in order to determine if clinical complete remission
Time frame: 1 year
overall survival (OS)
OS will be calculated from the start of induction therapy to death or last follow-up.
Time frame: 1 year
event-free survival (EFS)
EFS survival will be calculated from the start of induction therapy to relapse (molecular or clinical), death, or last follow-up.
Time frame: 1 year
disease free survival (DFS) rates
DFS will be calculated from the time of clinical CR (or better) to relapse (molecular or clinical), death, or last follow-up.
Time frame: 1 year
minimal residual disease (MRD) status
Molecular relapse is defined as the conversion of RT-PCR from MRD negative to MRD positive on two consecutive tests performed on bone marrow at least one week apart, while still meeting criteria for clinical CR.
Time frame: 1 year
safety
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be tabulated.
Time frame: 1 year
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