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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

Phase 2
18 Years
50 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

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Trial Information

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

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

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.

Inclusion Criteria:

- Patients must have pathologically documented acute lymphoblastic leukemia, excluding
mature B-cell ALL.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Daniel J. DeAngelo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2002

Completion Date:

June 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • ALL
  • acute lymphoblastic leukemia
  • chemotherapy
  • asparaginase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University Of Columbia Medical Center New York, New York