AN INTERGROUP PHASE II CLINICAL TRIAL FOR ADOLESCENTS AND YOUNG ADULTS WITH UNTREATED ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

Summary

Participants will be given a series of leukemia treatments that are divided into 4 sequential and different chemotherapy combinations. Each treatment will be explained in detail below. After completing this sequence which lasts for about 6 months, a final long course of treatment, referred to as [Double Quote]Maintenance Therapy,[Double Quote] will be given for an additional 20-32 months. The total time to complete the entire course of therapy will be approximately 2 years for women and 3 years for men. Almost all of this treatment after the first month can be given on an out-patient basis for most patients.

Remission Induction (Course I)
The following chemotherapy drugs will be given over the course of three weeks during the first month of therapy:
Allopurinol will be given once each day for two weeks (a total of 14 days). Additional fluids will be given intravenously (IV) .
Daunorubicin will be given once per week for 4 weeks on days 1, 8, 15, and 22.
Vincristine will be given once a week for 4 weeks on days 1, 8, 15, and 22.
Prednisone will be given on days 1-28.
Pegylated L-asparaginase (Peg-Asp) will be given at the beginning of the course on either day 4, 5, or 6.
A lumbar puncture (also known as a [Double Quote]spinal tap[Double Quote]) will be performed on day 1 and again on day 8 and day 29 of this course. On day 1, the chemotherapy drug Cytarabine will be injected into the spinal fluid over a period of approximately 1 minute. On day 8 and day 29, the chemotherapy drug Methotrexate will be injected into the spinal fluid over a period of approximately 1 minute.
A bone marrow aspirate and biopsy will be obtained on day 15 and at the end of the fourth week on day 29.
Daunorubicin will be given to you intravenously (IV) on day 1.
Pegylated L-asparaginase (Peg-Asp) will be given as an intramuscular (IM) injection or intravenously (IV) once on day 4 or day 5 or day 6.
Vincristine will be given to you by IV once a week for 2 weeks on days 1 and 8.

Remission Consolidation (Course II)
The following standard chemotherapy drugs will be given during the next 2 months of therapy:
Cyclophosphamide will be given on day 1 and again on day 29.
Cytarabine (known as Ara-C) will be given on days 1-4, 8-11, 29-32, and 36-39.
6-Mercaptopurine on days 1-14 and 29-42, at least one hour after the evening meal.
Vincristine on days 15, 22, 43, and 50.
Intrathecal Methotrexate will be given into the spinal fluid by lumbar puncture (known as an intrathecal injection) on days 1, 8, 15, and 22 of this course.
Pegylated L-asparaginase will be given on days 15 and 43.

Interim Maintenance Therapy (Course III)
As soon as participant has recovered sufficiently from Course II, the following standard chemotherapy drugs will be given without delay during the next cycle of therapy:
Vincristine will be given on days 1, 11, 21, 31, and 41.
Intravenous Methotrexate will be given on days 1, 11, 21, 31, and 41. The dose will be gradually increased each time until participant has a some side-effect such as a decrease in blood counts.
Intrathecal Methotrexate will be given together with hydrocortisone into the spinal fluid by lumbar puncture (known as an intrathecal injection), on days 1 and 31.
Pegylated L-asparaginase will be given on days 2 and 22.

Delayed Intensification Therapy (Course IV)
Doxorubicin will be given once per week for 3 weeks on days 1, 8, and 15.
Vincristine will be given once a week for 3 weeks on days 1, 8

Participant Eligibility

-Newly diagnosed patients with either B-precursor or T-precursor acute lymphoblastic leukemia (WHO criteria).
-Patients age ≥ 16 years and < 40 years.
-Patients with no prior therapy except for limited treatment with corticosteroids or hydroxyurea and
a single dose of intrathecal cytarabine.