Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
This study is not yet open for participant recruitment.
Verified September 2012 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborators:
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00558519
First received: November 14, 2007
Last updated: September 18, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: 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 phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL) |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Methotrexate
Cytarabine
Thioguanine
Dexamethasone acetate
Vincristine sulfate
Dexamethasone sodium phosphate
Methotrexate sodium
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
Pegaspargase
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Complete response rate [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Feasibility of extending the "pediatric approach" to adult patients up to 40 years of age [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Outcomes of adolescent and young adult patients treated on this study compared with those of patients treated per COG-AALL0232 [ Designated as safety issue: No ]
- Adherence of adult hematologists/oncologists and their patients to a "pediatric" acute lymphoblastic leukemia treatment regimen and identification of reasons for variances [ Designated as safety issue: No ]
- Outcomes of patients treated on this study according to pretreatment characteristics such as age, gender, white blood cell count, other hematologic parameters, blood chemistry, immunophenotype, cytogenetics and molecular genetic characteristics [ Designated as safety issue: No ]
- Outcomes of patients treated on this study according to treatment variables such as treatment site (academic center or community), and protocol adherence [ Designated as safety issue: No ]
- Analysis and description of the outcomes of patients treated on this study according to baseline psychosocial characteristics, demographics, and family support [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia (ALL)
- B-precursor or T-precursor ALL
- No Burkitt type leukemia (FAB L3; SIg positive; t(8;14) or variant)
- No known Ph+ ALL at time of diagnosis
Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol
Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):
- BCR-ABL fusion transcript determined by FISH or RT-PCR
- t(9;22)(q34;q11) or variant determined by cytogenetics
- All CALGB patients are required to participate in CALGB-8461
- All SWOG patients are required to participate in SWOG-9007
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No Down syndrome
PRIOR CONCURRENT THERAPY:
- No prior therapy for acute leukemia except emergency therapy (i.e., corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys
- Single-dose intrathecal cytarabine is allowed prior to registration for patient convenience provided systemic chemotherapy begins within 72 hours of intrathecal therapy
- Prior steroid therapy allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558519
Sponsors and Collaborators
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
Investigators
| Study Chair: | Richard A. Larson, MD | University of Chicago |
| Investigator: | John C. Grecula, MD | Ohio State University Comprehensive Cancer Center |
| Study Chair: | Selina M. Luger, MD | Abramson Cancer Center of the University of Pennsylvania |
| Study Chair: | Anjali Advani, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00558519 History of Changes |
| Other Study ID Numbers: | CDR0000574230, CALGB-10403, ECOG C10403, SWOG C10403 |
| Study First Received: | November 14, 2007 |
| Last Updated: | September 18, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
B-cell adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia untreated adult 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 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Pegaspargase |
Daunorubicin Dexamethasone Doxorubicin Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013