Overview

Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
6-Mercaptopurine
Allopurinol
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Leucovorin
Levoleucovorin
Mercaptopurine
Methotrexate
Prednisone
Vincristine
Criteria
1. Any other serious illnesses which would limit survival to <2 years, or psychiatric
condition which would prevent compliance with treatment or informed consent.

2. Uncontrolled or severe cardiovascular disease.

3. History of pancreatitis or overt coagulopathy (prior cerebrovascular accident or
hemorrhage, transient ischemic attack or deep venous thrombosis).

4. Elevations in bilirubin, creatinine, or amylase that may suggest impaired hepatic,
renal, or pancreatic function must be considered as potentially serious obstacles for
safe tolerance of the therapy prescribed in this protocol.

5. Prior use of the agents administered in this protocol for other non-malignant disease
may reduce the likelihood of beneficial outcome, and should also be considered prior
to enrolling patients.

6. Treatment under this protocol would expose an unborn child to significant risks.

Women and men of reproductive potential should agree to use an effective means of
birth control.

7. Unequivocal histologic diagnosis of Acute Lymphoblastic leukemia (ALL), FAB L1-or L2
or Acute Undifferentiated Leukemia (AUL).

8. Age ≥ 15 years

9. Prior Treatment: No prior treatment for leukemia, with three permissible exceptions:

i. emergency leukapheresis; ii. emergency treatment for hyperleukocytosis with
hydroxyurea; iii. cranial RT for CNS leukostasis (one dose only).