Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Dana-Farber Cancer Institute Massachusetts General Hospital Children's Hospital Boston |
---|---|
Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00476190 |
The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add a drug called PEG-asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL>
Condition | Intervention | Phase |
---|---|---|
Acute Lymphoblastic Leukemia |
Drug: Doxorubicin Drug: Cytarabine Drug: Methotrexate Drug: Vincristine Drug: Cyclophosphamide Drug: Methylprednisone Drug: Hydrocortisone Sodium Succinate Drug: Dexamethasone Drug: 6-MP Drug: PEG-Asparaginase Drug: Imatinib Drug: Etoposide Procedure: Radiation Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | ALL Adult Consortium Trial: Adult ALL Trial |
Estimated Enrollment: | 60 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Experimental
Complete remission achieved after Induction Phase
|
Drug: Doxorubicin
Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.
Drug: Cytarabine
Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks
Drug: Methotrexate
Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (proior to IV). Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks.
Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.
Drug: Cyclophosphamide
Consolidation IB: Intravenously on day 1
Drug: Methylprednisone
Prophase: Intravenously on days 1-3
Drug: Hydrocortisone Sodium Succinate
Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecallly 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.
Drug: Dexamethasone
Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.
Drug: 6-MP
Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.
Drug: PEG-Asparaginase
Induction: Intravenously on day 7. Consolidation IC: Intravenously every 2 weeks, starting on day 8. CNS Therapy: Intravenously every 2 weeks, starting on day 1. Consolidation II: Intravenously every 2 weeks, starting on day 1 of each cycle.
Drug: Imatinib
Used for PH+ ALL subjects only and is used continuously throughout every phase of treatment.
Drug: Etoposide
Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.
Procedure: Radiation Therapy
Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF
|
Arm B: Experimental
Failure to achieve complete remission after the Induction Phase
|
Drug: Doxorubicin
Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.
Drug: Cytarabine
Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks
Drug: Methotrexate
Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (proior to IV). Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks.
Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.
Drug: Cyclophosphamide
Consolidation IB: Intravenously on day 1
Drug: Methylprednisone
Prophase: Intravenously on days 1-3
Drug: Hydrocortisone Sodium Succinate
Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecallly 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.
Drug: Dexamethasone
Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.
Drug: 6-MP
Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.
Drug: PEG-Asparaginase
Induction: Intravenously on day 7. Consolidation IC: Intravenously every 2 weeks, starting on day 8. CNS Therapy: Intravenously every 2 weeks, starting on day 1. Consolidation II: Intravenously every 2 weeks, starting on day 1 of each cycle.
Drug: Imatinib
Used for PH+ ALL subjects only and is used continuously throughout every phase of treatment.
Drug: Etoposide
Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.
Procedure: Radiation Therapy
Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF
|
Radiation therapy will also be administered as part of this treatment regimen.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
Exclusion Criteria:
Contact: Daniel DeAngelo, MD | 617-632-2645 | ddeangelo@partners.org |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Daniel DeAngelo, MD | |
Children's Hospital of Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Lewis Silverman, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Christine: Connolly 617-726-5131 Cconnolly1@partners.org | |
Contact: Linda Rivera 617.724.5253 Lrivera3@partners.org | |
Principal Investigator: Karen K Ballen, MD | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Celeste Rojas 212-342-3590 cr2393@columbia.edu | |
United States, Ohio | |
Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Shawna Oxier 617-366-8309 Shawna.oxier@osumc.edu | |
Principal Investigator: William Blum, MD | |
United States, Utah | |
LDS Hospital | Recruiting |
Salt Lake City, Utah, United States, 84143 | |
Contact: Suzanne Kaempfer 801-408-1819 | |
Principal Investigator: Julie Asch, MD | |
Canada, British Columbia | |
Vancouver Cancer Center | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Anna Koochin, RN 60 875-4111 ext 67409 akoochin@bccancer.bc.ca | |
Principal Investigator: Yasser Mourad, MD | |
Canada, Ontario | |
Cancer Care Manitoba | Recruiting |
Winnipeg, Ontario, Canada, R3E 0V9 | |
Contact: Sandra Yap 204-787-2635 Sandra.yap@cancercare.mb.ca | |
Principal Investigator: Matthew D Seftel, MD | |
Canada, Quebec | |
Hopsital Maisonneuve Rosemont | Recruiting |
Montreal, Quebec, Canada, H1T 2M4 | |
Contact: Dominique Beaupre dbeaupre.hmr@ssss.gouv.qc.ca | |
Principal Investigator: Julie Bergeron, MD | |
Hospital Charles LeMoyne | Recruiting |
Greenfield Park, Quebec, Canada, J4V 2H1 | |
Contact: Pierre Desjardins, MD pierre.desjardins@rrsss16.gouv.qc.ca | |
Principal Investigator: Pierre Desjardins, MD |
Principal Investigator: | Daniel DeAngelo, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Daniel DeAngelo, MD, PhD ) |
Study ID Numbers: | 06-254 |
Study First Received: | May 18, 2007 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00476190 History of Changes |
Health Authority: | United States: Institutional Review Board |
ALL |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Pegaspargase Methotrexate Etoposide Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Vincristine Glucocorticoids Doxorubicin Imatinib Folic Acid Hydrocortisone acetate Antineoplastic Agents, Phytogenic Antimetabolites Leukemia, Lymphoid Immunologic Factors Folate Cyclophosphamide Etoposide phosphate Vitamin B9 |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 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 Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Hydrocortisone acetate Antineoplastic Agents, Phytogenic Antimetabolites Leukemia, Lymphoid |