ALL Adult Consortium Trial: Adult ALL Trial

Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Age Range:18 - 50
Start Date:April 2007
End Date:December 2018

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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>

- 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)

- 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.

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

- 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
We found this trial at
185 Cambridge Street
Boston, Massachusetts 02114
Boston, MA
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701 West 168th Street
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
New York, NY
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450 Brookline Ave
Boston, Massachusetts 2215
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Boston, MA
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Boston, Massachusetts 02115
Boston, MA
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Boston, Massachusetts 02115
Boston, MA
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Columbus, OH
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8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
Salt Lake City, UT
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Vancouver, British Columbia
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