Clinical Trial: Cancer, Leukemia and Lymphoma

AALL1131: Acute Lymphoblastic Leukemia (ALL) - high-risk (PRO00000497)

Full Name

AALL1131: 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


This trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk, acute lymphoblastic leukemia (ALL). At diagnosis, patients will initially enroll on the AALL08B1 classification study and either the COG standard (AALL0932) or high-risk (AALL1131 this study) B-precurser ALL trials, on which they will receive a conventional 3- or 4- drug Induction according to NCI-risk group. At the end of Induction, patients will be risk classified as High Risk or Very High Risk for post-Induction therapy. Participants classified as high risk will randomly be assigned to receive post-induction therapy with intrathecal methotrexate (given through the spinal fluid) (Arm A [standard]), or they will receive standard therapy and triple intrathecal therapy (methotrexate, hydrocortisone, and cytarabine). Very high risk participants will be randomly assigned to receive 1 of 3 treatment plans: 1) the usual modified Berlin Frankfurt Munster (MBFM) drugs; 2) therapy containing cyclophosphamide and etoposide (Experimental Arm 1); or 3) therapy containing the study drug plus cyclophosphamide and etoposide (Experimental Arm 2). In addition, there are optional osteonecrosis, magnetic resonance imaging and neurocognitive sub-studies. 

***Please note that at this time the very high risk arm is temporarily closed to enrollment (as of 9/13/2012).



Inclusion Criteria

Must be at least 1 year old, but younger than 31 years of age

Must be enrolled on AALL08B1 prior to enrollment on this study (AALL1131)

Newly diagnosed with B-precursor ALL; Patients with Down Syndrome are also eligible

Cannot have received an prior cytotoxic chemotherapy

Cannot be pregnant or breastfeeding

Must agree to use an effective birth control method