Trial Information

ALL Adult Consortium Trial: Adult ALL Trial

- 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.