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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00186875 |
The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia Lymphoma, Lymphoblastic |
Drug: Etoposide, cytarabine, vincristine, dexamethasone Drug: methotrexate, teniposide, PEG-asparaginase Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine Drug: L-asparaginase, erwinia asparaginase Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy Procedure: Hematopoietic Stem Cell Transplant Procedure: Natural Killer (NK) Cell Transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 42 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 |
Drug: Etoposide, cytarabine, vincristine, dexamethasone
See Detailed Description section for details of treatment interventions.
Drug: methotrexate, teniposide, PEG-asparaginase
See Detailed Description section for details of treatment interventions.
Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine
See Detailed Description section for details of treatment interventions.
Drug: L-asparaginase, erwinia asparaginase
See Detailed Description section for details of treatment interventions.
Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.
Procedure: Hematopoietic Stem Cell Transplant
See Detailed Description section for details of treatment interventions.
Procedure: Natural Killer (NK) Cell Transplant
See Detailed Description section for details of treatment interventions.
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Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contact: Sima Jeha, MD | 866-278-5833 | info@stjude.org |
United States, California | |
Rady Children's Hospital and Health Center | Recruiting |
San Diego, California, United States, 92123 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Sima Jeha, MD 866-278-5833 info@stjude.org | |
Principal Investigator: Sima Jeha, MD |
Principal Investigator: | Sima Jeha, MD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Sima Jeha, MD/Principle INvestigator ) |
Study ID Numbers: | ALLR17 |
Study First Received: | September 1, 2005 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00186875 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Lymphoblastic Acute |
Lymphoma Non-Hodgkin's Lymphoblastic |
Anti-Inflammatory Agents Dexamethasone Antimetabolites Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Vinblastine 6-Mercaptopurine Cyclophosphamide Hormones Lymphoblastic Lymphoma Etoposide phosphate Leukemia |
Pegaspargase Methotrexate Analgesics Alkylating Agents Lymphoma Etoposide Dexamethasone acetate Cytarabine Acute Lymphoblastic Leukemia Asparaginase Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents |
Dexamethasone Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Vinblastine 6-Mercaptopurine Hormones Pegaspargase Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Mitoxantrone Antineoplastic Agents, Phytogenic Antimetabolites Leukemia, Lymphoid Immunologic Factors Antineoplastic Agents |