A Study in Adults With Untreated Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT00136435 |
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Recruitment Status :
Active, not recruiting
First Posted : August 29, 2005
Last Update Posted : February 9, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia | Drug: prednisone Drug: doxorubicin Drug: vincristine Drug: methotrexate Drug: asparaginase Drug: dexamethasone Radiation: cranial radiation Drug: leucovorin Drug: cytarabine Drug: hydrocortisone Drug: 6-mercaptopurine (6-MP) Drug: e. coli L-asparaginase | Phase 2 |
This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3) intensification, and 4) continuation.
The induction phase lasts one month and eight drugs are used during this phase of treatment. The drugs are administered as follows:
- Prednisone; on days 1-28:
- Vincristine; on days 1, 8, 15, and 22:
- Doxorubicin; on days 1 and 2:
- Methotrexate; on day 3;
- Leucovorin; 36 hours after methotrexate:
- Asparaginase; on day 5:
- Intra-thecal Cytarabine; on days 1, 15, and 29:
- Intra-thecal Methotrexate/Hydrocortisone; on days 15 and 29
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy. If on day 29, the patients' bone marrow and peripheral blood counts are not in complete remission, then the patient may receive vincristine on days 29, 36 and 43. Bone marrow biopsy will be repeated weekly until complete remission is documented. If the patient does not achieve complete remission by day 49, they will be removed from the study.
Central nervous system (CNS) therapy begins immediately after the end of the induction therapy. This phase of treatment should last 3 weeks. Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a two week period. Anti-leukemia drugs will also be given orally. The drugs given are as follows: Vincristine; on day 1: Doxorubicin; on day 1: 6-mercaptopurine (6-MP); on days 1-14: Intra-thecal Methotrexate/Cytarabine; 4 times over 2 weeks.
Radiation therapy (RT) will be delivered in 10 daily treatments during the CNS phase of therapy.
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks. It consists of cycles of chemotherapy repeated every 3 weeks, along with asparaginase administered weekly. The drugs given are as follows: Vincristine; day 1: Dexamethasone; days 1-5: 6-MP; days 1-14: Doxorubicin; day 1: Asparaginase; weekly: Methotrexate; weekly: Intra-thecal Hydrocortisone/Methotrexate/cytarabine; every 18 weeks.
The continuation phase of treatment begins after the intensification phase. It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years. The drugs given are: Vincristine; day 1 : Prednisone or Dexamethasone; days 1-5: 6-MP; days 1-14: Methotrexate; weekly: Intra-thecal Methotrexate/Cytarabine/Hydrocortisone: every 18 weeks.
During this study, blood tests will be performed at the start of therapy, at day 29 post induction and at the time of each intra-thecal therapy (every 18 weeks).
Bone marrow biopsy/aspirate will be done days 15 and 29 of induction, then every 6 months until completion.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol |
| Study Start Date : | June 2002 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2018 |
| Arm | Intervention/treatment |
|---|---|
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Only Arm for this study
Only Arm for this study
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Drug: prednisone
Induction Phase: Given orally on days 1-28 Drug: doxorubicin Induction Phaese: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle Drug: vincristine Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not acheived, will be given on days 29, 36 and 43. CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle Drug: methotrexate Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks Drug: asparaginase Induction: Given into the muscle on day 5 Drug: dexamethasone Intensification: Given orally on days 1-5 of each cycle Radiation: cranial radiation Given in 10 daily treatments during CNS therapy phase Drug: leucovorin Induction: Given intravenously or orally 36 hours after methotrexate Drug: cytarabine Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks
Other Name: Ara-C Drug: hydrocortisone Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks. Drug: 6-mercaptopurine (6-MP) CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14. Drug: e. coli L-asparaginase Intensification: Given in to the muscle weekly. |
- To determine the feasibility, safety and efficacy of the high-risk pediatric treatment regimen in adult patients between the ages of 18 and 50 years
- To determine the safety and optimal dosing of L-asparaginase during the intensification period [ Time Frame: 5 years ]
- to determine the effect of weekly E. coli L-asparaginase by evaluating serum asparaginase levels in all patients [ Time Frame: 5 years ]
- to determine the safety of individualized dosing of E. coli L-asparaginase based upon asparaginase levels [ Time Frame: 5 years ]
- to evaluate the outcome of patients based upon minimal residual disease status (MRD) after 28 days of multi-agent induction chemotherapy [ Time Frame: 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL.
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No prior therapy for leukemia with the following exceptions:
- up to one week of steroids;
- emergent leukapheresis;
- emergency treatment for hyperleukocytosis with hydroxyurea;
- cranial RT for CNS leukostasis (one dose only);
- emergent radiation therapy to the mediastinum.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Between the ages of 18 to 50 years.
Exclusion Criteria:
- Uncontrolled active infection.
- Pregnancy or nursing mothers.
- Prior history of pancreatitis.
- Prior history of a cerebrovascular accident or hemorrhage.
- Evidence of infection with the human immunodeficiency virus.
- Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
- The treating physician should consider all relevant medical and other considerations when deciding whether this protocol is appropriate for a particular patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136435
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| University Of Columbia Medical Center | |
| New York, New York, United States | |
| Canada, Manitoba | |
| Manitoba Blood & Marrow Transplant Program CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada | |
| Canada, Ontario | |
| McMaster University Medical Center | |
| Hamilton, Ontario, Canada | |
| Queen's University | |
| Kingston, Ontario, Canada | |
| London Health Sciences Centre | |
| London, Ontario, Canada | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Hospital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada | |
| Royal Victoria Hospital | |
| Montreal, Quebec, Canada | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada | |
| Canada | |
| Queen Elizabeth II | |
| Halifax, Canada | |
| Principal Investigator: | Daniel J. DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
| Responsible Party: | Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00136435 History of Changes |
| Other Study ID Numbers: |
01-175 |
| First Posted: | August 29, 2005 Key Record Dates |
| Last Update Posted: | February 9, 2018 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute:
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ALL acute lymphoblastic leukemia chemotherapy asparaginase |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Dexamethasone Prednisone Hydrocortisone |
Doxorubicin Methotrexate Cytarabine Vincristine Asparaginase 6-Mercaptopurine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |