ALL Adult Consortium Trial: Adult ALL Trial
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT00476190
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Cytarabine Complete remission achieved after Induction Phase Arm A E. coli Asparaginase Complete remission achieved after Induction Phase Arm A Radiation Therapy Complete remission achieved after Induction Phase Arm B Radiation Therapy Failure to achieve complete remission after the Induction Phase Arm B E. coli Asparaginase Failure to achieve complete remission after the Induction Phase Arm A Cyclophosphamide Complete remission achieved after Induction Phase Arm B Etoposide Failure to achieve complete remission after the Induction Phase Arm A Doxorubicin Complete remission achieved after Induction Phase Arm A Methotrexate Complete remission achieved after Induction Phase Arm A Methylprednisone Complete remission achieved after Induction Phase Arm A Vincristine Complete remission achieved after Induction Phase Arm A Hydrocortisone Sodium Succinate Complete remission achieved after Induction Phase Arm A PEG-Asparaginase Complete remission achieved after Induction Phase Arm A Dexamethasone Complete remission achieved after Induction Phase Arm A 6-MP Complete remission achieved after Induction Phase Arm A Imatinib Complete remission achieved after Induction Phase Arm A Etoposide Complete remission achieved after Induction Phase Arm B Doxorubicin Failure to achieve complete remission after the Induction Phase Arm B Cyclophosphamide Failure to achieve complete remission after the Induction Phase Arm B Methylprednisone Failure to achieve complete remission after the Induction Phase Arm B Cytarabine Failure to achieve complete remission after the Induction Phase Arm B Methotrexate Failure to achieve complete remission after the Induction Phase Arm B Vincristine Failure to achieve complete remission after the Induction Phase Arm B Hydrocortisone Sodium Succinate Failure to achieve complete remission after the Induction Phase Arm B Dexamethasone Failure to achieve complete remission after the Induction Phase Arm B PEG-Asparaginase Failure to achieve complete remission after the Induction Phase Arm B 6-MP Failure to achieve complete remission after the Induction Phase Arm B Imatinib Failure to achieve complete remission after the Induction Phase
- Primary Outcome Measures
Name Time Method To evaluate the feasibility of administering PEG asparaginase in the adult ALL population. 3 years Measured as the percentage of patients who, after having achieved a CR after induction therapy, complete \>25 weeks of IV PEG asparaginase as part of intensification therapy.
To evaluate toxicity of administering PEG asparaginase in the adult ALL population. 3 years Measured as frequencies of grade III or higher adverse events.
- Secondary Outcome Measures
Name Time Method Overall survival, defined as time from study entry to death from any cause, will be estimated using Kaplan-Meier methods. 3 years To determine the complete response rate at the end of induction therapy. 2 years Disease-free survival, defined as the time from achieving a complete remission to the first of disease recurrence or death, will be estimated using Kaplan-Meier methods. 3 years
Trial Locations
- Locations (15)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Boston
🇺🇸Boston, Massachusetts, United States
Beth Isreal Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Hopital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
Hopital Maisonneuve Rosemont
🇨🇦Montreal, Quebec, Canada
Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Vancouver Cancer Center
🇨🇦Vancouver, British Columbia, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
QEII, Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada