Phase III Randomized Comparison of Intravenous vs Oral MP During Consolidation and of PRED vs DM during Induction, Consolidation, and Maintenance in Children with Good-Prognosis and Intermediate-Prognosis ALL Receiving Standard Chemotherapy
Note: this outline was patched together from the NCI online protocol and input from parents of kids with ALL. It is summarized here for our convenience, so that we can quickly compare our protocols. We do not guarantee the accuracy of this outline - it is not an official document. You can contact your child's oncologist and ask for the complete protocol document if you are interested in the details of your child's protocol.
Note: the cancer.gov listing of this protocol includes a bibliography of articles about this trial.
Protocol initiated: This trial was the predecessor of CCG 1952; we know that it was accepting patients 7/95 and it ran about 2 years.
# patients: 576
4 arms of treatment:
Rationale behind including delint:
CCG-104 used standard chemotherapy ("standard therapy" at that point in time did not include delint for favorable prognosis) in children with favorable prognosis ALL, has a long term survival without evidence of leukemia of approximately 60%.
The subsequent study, CCG-1881, compared the addition of a phase known as "delayed intensification" (delint) to this standard therapy in hopes of improving the outcome. Although the final results of this study are not yet available, it is believed that the use of a delayed intensification should be considered as standard therapy for ALL.
CCG-105 utilized delayed intensification for children with intermediate prognosis ALL and obtained a long term survival without evidence of leukemia of approximately 75%. Thus all patients enrolled in this study will receive a delayed intensification phase.
Rationale behind testing dexamethasone-prednisone:
Other uncontrolled studies in ALL suggested improved survival by treating patients with IV MP and PO prednisone. Because the following variations were not done in controlled studies:
it is unknown if the favorable results obtained were from random chance or because of the treatment used.
Not much different from CCG 1952, which followed this study. CCG 1952 uses dexamethasone and prednisone at time. 6-MP is given orally in the newer study. CCG 1952 also given ara C SQ or IV, not only IT as in the CCG 1922 study. Why CCG 1952 uses 2 delints instead of one: I have not yet found an answer. Note that CCG 1961, concurrent to CCG 1952 but for higher risk, uses only 1 delint on 2 arms of the study.
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Last Updated 3/06
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