ALL Adult Consortium Trial: Adult ALL Trial
Overview[ - collapse ][ - ]
| Purpose | 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 drugs called PEG-asparaginase and E. coli 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> |
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| Condition | Acute Lymphoblastic Leukemia |
| Intervention | 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 Drug: E. coli Asparaginase |
| Phase | Phase 2 |
| Sponsor | Dana-Farber Cancer Institute |
| Responsible Party | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier | NCT00476190 |
| First Received | May 18, 2007 |
| Last Updated | February 11, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 18, 2007 |
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| Last Updated Date | February 11, 2014 |
| Start Date | April 2007 |
| Estimated Primary Completion Date | June 2016 |
| Current Primary Outcome Measures | To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment in adult patient 18 year of age or older. [Time Frame: 3 years] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | ALL Adult Consortium Trial: Adult ALL Trial |
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| Official Title | ALL Adult Consortium Trial: Adult ALL Trial |
| Brief Summary | 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 drugs called PEG-asparaginase and E. coli 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> |
| Detailed Description | - This study has several periods of treatment called phases and uses several different drugs in each phase. The drugs may be given by mouth, into a vein, or into the spinal fluid (called intrathecal chemotherapy). In some individuals this treatment helps prevent leukemia cells from coming back in the spinal fluid and brain. Radiation therapy will also be administered as part of this treatment regimen. - The treatment program consists of 2-different treatment arms with six separate phases of therapy. The phases of treatment are: (1) Steroid prophase (2) Induction (3) Consolidation I (4) Central nervous system (CNS) therapy (5) Consolidation II (6) Continuation. - The participants treatment arm will depend on the status of their leukemia at the end of the induction therapy (the second phase of treatment). Arm A: all participants who achieve complete remission after Induction and Arm B: all participants who fail to achieve a complete remission after Induction. - Steroid Prophase: All participants are involved in this treatment phase which consists of two drugs, one given intravenously (IV) and one given intrathecally. This phase lasts 3 days and the purpose is to collect scientific data that might be useful in the future and to see how steroids work in treating leukemia - Induction: This phase begins immediately after the steroid prophase and lasts about 1 month. Induction is used to cause a remission. Eight drugs are used during this phase of treatment, and administration is either orally, IV or intrathecal. On day 29, participant's bone marrow and peripheral blood counts will be tested. If they have achieved complete remission or partial remission, they will proceed to the next phase of treatment. If they are not in complete remission, they will receive vincristine by IV on days 32, 39 and 46, until complete remission is achieved. If they do not achieve complete or partial remission by day 53 they will be removed from the study. - Consolidation I: This phase of treatment begins as soon as there is a documented confirmation that the participant's leukemia is either in complete or partial remission. Treatment in this phase lasts about 7 weeks and is intended to further reduce the number of leukemia cells in the body. This consolidation treatment consists of 3 phases: 1A, 1B and 1C. Each phase involves a three week cycle of chemotherapy. Arm A and Arm B will be assigned according to remission status after induction therapy and will determine the order that the participant follows the Consolidation phases. - Central Nervous System (CNS) Therapy: CNS therapy begins 3 weeks after the end of Consolidation I therapy and should last 3 weeks. Treatment includes a series of lumbar punctures with the administration of anti-leukemia drug as well as oral drugs and IV drugs. Radiation therapy will also be given during this phase of therapy. The purpose of radiation therapy is to prevent leukemia from coming back in the brain. Radiation therapy will be given in either 8 or 10 daily treatments. - Consolidation II Therapy: This phase begins as soon as CNS therapy ends and lasts about 27-30 weeks. It consists of cycles of chemotherapy repeated every three weeks along with IV PEG-asparaginase administered every 3 weeks. The cycles will be repeated until the participant receives a total of 10 doses of asparaginase. - Continuation Therapy: This phase begins after the end of the Consolidation II phase. The goal of this phase is to get rid of all leukemia in the body. It consists of cycles of chemotherapy repeated every three weeks and will last until the participant has been in remission for two years. - During all phases of treatment, participants will have tests and procedures to monitor their health and for research purposes. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Acute Lymphoblastic Leukemia |
| Intervention | 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 (prior 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. Drug: Vincristine 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: Intrathecally 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 Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose. Consolidation II: Intravenously every 3 weeks. Drug: Imatinib Used for PH+ ALL subjects enrolled prior to May 1st 2011 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 Drug: E. coli Asparaginase Intramuscularly Day 7 of Induction. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 112 |
| Estimated Completion Date | June 2016 |
| Estimated Primary Completion Date | June 2014 |
| Eligibility Criteria | Inclusion Criteria: - Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8) - Age 18.00-50.99 years Exclusion Criteria: - Prior anti-leukemic therapy except 1 week or less of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis - Known HIV positive - Secondary ALL - Pregnant or breast feeding women - Patients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00476190 |
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| Other Study ID Numbers | 06-254 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Dana-Farber Cancer Institute |
| Study Sponsor | Dana-Farber Cancer Institute |
| Collaborators | Massachusetts General Hospital Children's Hospital Boston NCIC Clinical Trials Group |
| Investigators | Principal Investigator: Daniel DeAngelo, MD Dana-Farber Cancer Institute |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02215 |
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| Children's Hospital of Boston | Boston, Massachusetts, United States, 02115 |
| Massachusetts General Hospital | Boston, Massachusetts, United States, 02114 |
| Beth Isreal Deaconess Medical Center | Boston, Massachusetts, United States, 02215 |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York, United States, 10032 |
| Ohio State University Medical Center | Columbus, Ohio, United States, 43210 |
| LDS Hospital | Salt Lake City, Utah, United States, 84143 |
| Vancouver Cancer Center | Vancouver, British Columbia, Canada, V5Z 4E6 |
| Cancer Care Manitoba | Winnipeg, Manitoba, Canada, R3E 0V9 |
| The Moncton Hospital | Moncton, New Brunswick, Canada |
| QEII, Health Sciences Centre | Halifax, Nova Scotia, Canada, B3H 2Y9 |
| Hopital Charles LeMoyne | Greenfield Park, Quebec, Canada, J4V 2H1 |
| McGill University Department of Oncology | Montreal, Quebec, Canada |
| Hopital Notre-Dame | Montreal, Quebec, Canada |
| Hopital Maisonneuve Rosemont | Montreal, Quebec, Canada, H1T 2M4 |