A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01920737|
Recruitment Status : Recruiting
First Posted : August 12, 2013
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Daunorubicin Drug: Vincristine Drug: Prednisone Drug: PEG-Asparaginase Drug: Methotrexate Drug: 6-MP (6-Mercaptopurine) Drug: Cyclophosphamide Drug: Cytarabine Drug: Leucovorin Drug: Dexamethasone Other: Blood draw Device: CT/PET scans||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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 Other: Blood draw Device: CT/PET scans
PET or CT scan every 6 months for 3 years
- rate of molecular remission [ Time Frame: 1 year ]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 ]
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 ]OS will be calculated from the start of induction therapy to death or last follow-up.
- event-free survival (EFS) [ Time Frame: 1 year ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920737
|Contact: Jae Park, MD||212-639-4048|
|Contact: Martin Tallman, MD||212-639-3849|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jae Park, MD 212-639-4048|
|Contact: Martin Tallman, MD|
|Principal Investigator: Jae Park, 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||Active, not recruiting|
|Durham, North Carolina, United States, 27701|
|United States, Pennsylvania|
|Lehigh Valley Health Network||Recruiting|
|Allentown, Pennsylvania, United States, 18103|
|Contact: Brian Patson, MD 610-402-7880|
|Principal Investigator:||Jae Park, MD||Memorial Sloan Kettering Cancer Center|