CCG 1991

Phase III Randomized Study of Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification in Children With 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.

This trial on the clinicaltrials.gov site.

This trial on the cancer.gov site.


Treatment for standard risk ALL, defined as presenting features of at least one of the following:

Note the following stipulations:

Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed; CNS or testicular leukemia allowed

Specific Aims:

Also:


Protocol Outline

Patients

are randomized to one of four treatment arms.

Patients with CNS disease at diagnosis are assigned to treatment arm II and undergo cranial irradiation.

Patients with any of the following unfavorable bone marrow features and/or unfavorable cytogenetic features are assigned to the augmented treatment regimen by day 21 of induction chemotherapy or at the beginning of consolidation chemotherapy:

Unfavorable marrow status is defined as:

OR

Unfavorable cytogenetics:

Projected Accrual: A total of 2,173 randomized patients will be accrued for this study within 3.5 years.


4 Weeks Induction (All patients receive standard induction chemotherapy)

(Note: Patients without CNS disease at diagnosis receive methotrexate (MTX) IT on days 7 and 28. Patients with CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28.)

(Notes: Patients who have achieved M1 marrow status by day 28 of induction therapy and have favorable bone marrow status and cytogenetics receive induction chemotherapy for an additional 14 days and then proceed to standard consolidation therapy once blood counts have recovered. Patients with M3 bone marrow status at day 28 of induction therapy are taken off the protocol. All other patients are assigned to the augmented treatment regimen. These are the "Unfavorable marrow status" patients referred to above.)

4 Weeks Consolidation

Patients without CNS disease at diagnosis receive

Patients with CNS disease at diagnosis receive

Patients with testicular disease receive bilateral testicular radiotherapy 5 days a week for 1 week and then for 3 consecutive days during the next week.


Arm I (standard arm - oral MTX, single delint)

Interim maintenance I (7 weeks)

Delayed intensification (7 weeks)

Interim maintenance II (7 weeks)

Maintenance


Arm II (standard + two delayed intensifications)

Interim maintenance I (7 weeks)

Delayed intensification I (7 weeks)

Interim maintenance II (7 weeks)

Delayed intensification II (7 weeks)

Interim maintenance II (7 weeks)

Maintenance


Arm III (escalating doses of MTX IV w/o leucovorin rescue)

Interim maintenance I (7 weeks)

Delayed intensification (7 weeks)

Interim maintenance II (7 weeks)

Maintenance


Arm IV (escalating doses of MTX IV w/o leucovorin rescue, 2 delayed intensifications)

Interim maintenance I (7 weeks)

Delayed intensification I (7 weeks)

Interim maintenance II (7 weeks)

Delayed intensification II (7 weeks)

Maintenance


Augmented Treatment

Patients receive induction chemotherapy:

Patients without CNS disease at diagnosis receive MTX IT on days 21 and 35. Patients with CNS disease at diagnosis receive MTX IT on days 21 and 28.

Consolidation therapy

Patients without CNS disease at diagnosis receive MTX IT on days 7, 14, and 21. Patients with CNS disease at diagnosis receive MTX IT on day 7 and cranial irradiation as in the randomized treatment section. Patients with testicular leukemia receive radiotherapy as in the randomized treatment section.

Interim maintenance I

Delayed intensification I chemotherapy

Interim maintenance II chemotherapy

Delayed intensification II chemotherapy

Maintenance


Follow-up:

Patients are followed every 4-8 weeks for one year, every 3 months for one year, every 6 months for one year, and then annually thereafter.

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Last Updated 4/06

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