Clinical Trial COGAALL1131
Title
A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND #73789, NSC# 606869) in the Very High Risk Stratum
Principal Investigator(s)
Details
- Protocol No. COGAALL1131
- Open Date: 04/05/2012
- Staging: Phase III
- Age Group: Both Child and Adult
- Scope: National
- Objective: - To determine if the administration of post-Induction age adjusted ITT on an MBFM-IMHDM backbone will improve 5-year DFS of children with HR-ALL compared to age adjusted IT MTX. - To determine, in a randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) or the clofarabine + cyclophosphamide + etoposide combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control Arm). - To determine, in a randomized fashion, if the cyclophosphamide + etoposide + clofarabine containing combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to the cyclophosphamide + etoposide combination regimen (Experimental Arm 1).
- Disease Sites: Leukemia; Pediatric Leukemia
- Therapies: Chemotherapy - cytotoxic; Radiotherapy
- Drugs: 6-thioguanine (6-TG); Clofarabine; Cyclophosphamide (CTX); Cytarabine (ARA-C); Dexamethasone; Dosorubicin; Doxorubicin; Etoposide; Hydrocortisone; Levoleucovorin; Mercaptopurine; Methotrexate; Pegaspargase (Oncaspar); Prednisone; Vincristine
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01406756
- Secondary Protocol No: Not Specified
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 1 Year to 30 Years |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
• Patients must have newly diagnosed B-precursor acute lymphoblastic leukemia (ALL); patients with Down syndrome (DS) are also eligible
• Patients must have one of the following:
• NCI high-risk ALL or NCI standard-risk ALL with central nervous system (CNS), testicular leukemia, and/or steroid pre-treatment, and be enrolled in COG AALL08B1; patients that begin therapy on this study (AALL1131) prior to enrollment on COG AALL08B1 are ineligible
• NCI standard-risk ALL, be enrolled in COG AALL08B1 or COG AALL0932 and completed AALL0932 induction treatment and been classified as high-risk or very high-risk
• Patients with BCR-ABL1 (Philadelphia chromosome positive) are not eligible for post-induction therapy on this study; non-DS patients may be eligible to enroll in COG AALL0622 or successor COG Ph+ ALL trial by day 15 induction
• DS HR-ALL patients with induction failure or BCR-ABL1 are not eligible for post-induction
• No VHR-ALL patients with significant hepatic dysfunction at the time of post-induction randomization defined as:
• Direct bilirubin > 1.5 times upper limit of normal (ULN) for age
• SGPT (ALT) ≥ 3 times ULN for age
• Lipase > 2.0 times ULN for age
• Patients cannot have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
PATIENT CHARACTERISTICS:
• White blood cell count (WBC) criteria:
• Age 1-9.99 years: WBC ≥ 50 000/μL
• Age 10-30.99 years: Any WBC
• Age 1-30.99 years: Any WBC with:
• Testicular leukemia
• CNS leukemia (CNS3)
• Steroid pretreatment
• No very high-risk (VHR) acute lymphoblastic leukemia (ALL) patients with hepatitis B or C infection or history of cirrhosis at the time of post-induction randomization
• Negative pregnancy test
• Patients of childbearing potential must agree to use an effective birth control method
• Female patients who are lactating must agree to stop breast-feeding
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of acute lymphoblastic leukemia (ALL) or any cancer diagnosed previously, with the exception of steroids and intrathecal cytarabine for the current diagnosis of ALL
• Patients receiving prior steroid therapy may be eligible
• No concurrent intensity-modulated radiotherapy
Learn More
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