A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia
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.
Drug: 6-MP (6-Mercaptopurine)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia|
- rate of molecular remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]i.e. minimal residual disease (MRD) negative status, as assessed by PCR and flow cytometry in the bone marrow after phase I induction.
- complete remission (CR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
- overall survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]OS will be calculated from the start of induction therapy to death or last follow-up.
- event-free survival (EFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]EFS survival will be calculated from the start of induction therapy to relapse (molecular or clinical), death, or last follow-up.
- disease free survival (DFS) rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]DFS will be calculated from the time of clinical CR (or better) to relapse (molecular or clinical), death, or last follow-up.
- minimal residual disease (MRD) status [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Leukemia Patients
The treatment plan has 6 treatment cycles. The cycle names are listed in the following order:
Induction Phase I - Induction Phase II - Intensification I - Re-induction I - Intensification II - Re-induction II Each cycle is given over a period of 4-6 weeks and the interval between them can range between 1-3 weeks. Based the patients medical condition, the doctor may decide to change the timing of the drugs, the interval between the drugs in a cycle, or the interval between the cycles. After receiving all cycles you will continue with a 36 months treatment part that is called Maintenance.
In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.Drug: Vincristine Drug: Prednisone Drug: PEG-Asparaginase Drug: Methotrexate Drug: 6-MP (6-Mercaptopurine) Drug: Cyclophosphamide Drug: Cytarabine Drug: Leucovorin Drug: Dexamethasone
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920737
|Contact: Dan Douer, MD||212-639-2471|
|Contact: Jae Park, MD||212-639-4048|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Dan Douer, MD 212-639-2471|
|Contact: Jae Park, MD 212-639-4048|
|Principal Investigator: Dan Douer, MD|
|Weill Cornell Medical Center||Recruiting|
|New York, New York, United States|
|Contact: Ellen Ritchie, MD|
|Principal Investigator: Ellen Ritchie, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27701|
|Principal Investigator: Arati Rao, MD|
|Principal Investigator:||Dan Douer, MD||Memorial Sloan Kettering Cancer Center.|