Phase III Randomized Study of Methotrexate With or Without Delayed Intensification in Patients With Low-Risk Acute Lymphoblastic Leukemia.
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.
POG 9904 NCI PDQ (takes you to the cancer.gov site)
POG institutions enter all patients on POG 9900, which is kind of a holding protocol for patients. All patients, regardless of risk assessment, enroll in this trial at diagnosis and are on it through induction (4 weeks). POG 9900 delineates administrative methods and how data is gathered (among other things). At the end of 4 weeks - "induction", the lab reports on the leukemia cells obtained at dx are available, and other factors such as slow- or rapid-response are known. At that time, risk level is assessed and pre-B ALL patients over 1 year old are put on:
Induction therapy itself is different depending on the institution's risk classification guidelines. For the above 3 trials, induction intensity for the above 3 trials is determined by age, WBC, CNS or testicular disease. Standard risk patients get a 3-drug induction; patients in the high risk group receive 4-drug induction.
Other protocols which begin with 9900 but may have different inductions are:
An interesting point: parents do not have to decide whether or not to enroll in a clinical trial until day 28.
Treatment for low risk ALL, defined as presenting features of:
and must have one of the following present:
Note: Parents do not have to enroll their child on the protocol until day 29 (within 72 hours of day 29), the last day of induction therapy (the child must be in remission to enroll in the trial).
All patients receive induction therapy as per POG 9900. (weeks 1-4)
3-drug induction (vinc, asp, dex) (please double check this outline on the COG or the cancer.gov site)
Patients are then stratified according to genetics for consolidation therapy (see next heading):
All patients are randomized to long or short MT infusion. Also, all of the trisomy 4/10 alone patients do not have delayed intensification ("delint"); but half of the tel/aml patients will have a delint.
Another way of saying this: They feel confident that trisomy 4/10 doesn't require more intensive therapy, but still want to know if long/short MT infusion makes a difference. They think that tel/aml might be prognostically just like trisomy 4/10, but are not sure whether or not a more intensive therapy, or delayed intensification, will benefit this subgroup, so they are randomizing this subgroup to no delint or a single delint. The delint group will also be randomized to long/short MT infusion to check that too (Arms III and IV).
Stratum 1: trisomy 4/10 but not TEL/AML1 - begins week 5, lasts to week 24, "consolidation therapy":
Patients in both arms I and II also receive:
Stratum 2: TEL/AML1 (might have trisomy 4/10 too) - begins week 5
Delint arms (delint with long or short MT infusion) - delint is 8 weeks long
Patients in both arms III and IV also receive :
All patients receive continuation therapy beginning on week 25 for arms I and II and week 33 for arms III and IV and continuing to week 130 for all arms.
Arms I and II
Arms III and IV
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
A total 902 patients will be accrued for this study within 3.22 years.
(back to ALL Trials page)
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Last Updated 4/06
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