Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL
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Purpose
RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This trial is studying biomarkers to classify young patients with acute lymphoblastic leukemia (ALL) and remission induction therapy in young patients with B-precursor ALL.
| Condition | Intervention |
|---|---|
|
Leukemia |
Drug: SC-PEG E. coli L-asparaginase Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | ALinC 17, Classification ©), B-precursor Induction Treatment (I) |
- Collection of the clinical and laboratory data necessary for placing patients with acute lymphoblastic leukemia (ALL) onto the proper therapeutic trial (Classification) [ Designated as safety issue: No ]
- Creation of an administrative base to capture classification data for correlative studies in ALL treatment protocols and series of historical protocols (Classification) [ Designated as safety issue: No ]
- Creation of appropriate induction regimens for patients (Induction therapy) [ Designated as safety issue: No ]
- Correlation between event-free survival and measures of minimal-residual disease/early response [ Designated as safety issue: No ]
| Estimated Enrollment: | 2176 |
| Study Start Date: | December 1999 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stratum 3
Patients receive oral dexamethasone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; pegaspargase intramuscularly (IM) on day 4, 5, or 6; cytarabine intrathecally (IT) on day 1; and methotrexate IT on day 8 (some patients also receive methotrexate IT on days 15 and 22).
|
Drug: cytarabine
Given IT
Drug: dexamethasone
Given orally
Drug: methotrexate
Given IT
Drug: pegaspargase
Given IM
Drug: vincristine sulfate
Given IV
|
|
Experimental: Stratum 4
Patients receive oral prednisone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; IM SC-PEG E. coli asparaginase on days 2, 5, 8, 12, 15, and 19; daunorubicin hydrochloride IV over 15-20 minutes on days 8, 15, and 22; and methotrexate IT on days 1 and 8 (some patients also receive methotrexate IT on days 15 and 22).
|
Drug: SC-PEG E. coli L-asparaginase
Given IM
Drug: cytarabine
Given IT
Drug: daunorubicin hydrochloride
Given IV
Drug: methotrexate
Given IT
Drug: prednisone
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets one of the following sets of criteria:
Classification study:
- Newly diagnosed ALL*
Must have one of the following:
- ≥ 25% blasts in bone marrow
- ≥ 100,000/μl peripheral blood WBC with ≥ 75% blasts, if bone marrow aspiration is omitted for any reason other than medical contraindication
- ≥ 30,000/μl WBC with ≥ 75% blasts, if bone marrow aspiration is omitted because of medical contraindication
- Immunophenotype and Wright's stain morphology of blast cells consistent with acute lymphocytic leukemia
- ≤ 21 years of age at the time of diagnosis
- No previous registration on 9900
- Samples must be sent for local institution and COG Reference Laboratory studies NOTE: *It is urged that a bone marrow aspiration be performed for every patient with suspected ALL. However, a marrow is not required for patients with ≥ 100,000/μl peripheral blood WBC and ≥ 75% blasts or for those patients whose clinical condition precludes performing the procedure safely. Patients with a medical contraindication to the procedure must be discussed with one of the study coordinators and must have a peripheral blood WBC of ≥ 30,000/μl with ≥ 75% blasts.
Induction therapy study:
- Patients must have a confirmed diagnosis of B-precursor acute lymphoblastic leukemia
- Patients must be 1.001 to 21.999 years at diagnosis NOTE: Patients meeting all of the above eligibility criteria are eligible for registration on 9900 whether or not they are to be entered on a COG frontline protocol for treatment of newly diagnosed ALL. Registration on 9900 is required for all legacy POG institution patients in order to be eligible for entry on the following COG ALL studies, which are either currently open or only temporarily closed: P9407, 9904, 9905, 9907, AALL0031 and AALL00P2.
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
Previously untreated, with the following exception:
- Steroid treatment* in the 48-hour period just prior to study entry will be allowed provided that a physical examination and CBC with differential were performed IMMEDIATELY prior to beginning steroids and results of both are known NOTE: *Patients on chronic steroid treatment for another disease are NOT eligible for a COG New ALL protocol.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Dale Jeanette Pullen, University of Mississippi Cancer Clinic |
| ClinicalTrials.gov Identifier: | NCT01225874 History of Changes |
| Other Study ID Numbers: | CDR0000078618, COG-9900, POG-9900 |
| Study First Received: | October 20, 2010 |
| Last Updated: | October 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pegaspargase Asparaginase Cytarabine Daunorubicin Dexamethasone Methotrexate |
Prednisone Vincristine Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013