COG-AALL0331

Phase III Randomized Study of Different Combination Chemotherapy Regimens in Pediatric Patients With Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia./p>

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed 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 cancer.gov site.


Classification of newly diagnosed leukemia

All newly diagnosed ALL patients are enrolled in COG AALL03B1, Classification of Acute Lymphoblastic Leukemia.

At diagnosis of ALL, the oncologists at the local hospital determine an initial risk classification as follows:

(This method of risk classification is known as "NCI/Rome criteria".)

At diagnosis samples of blood/bone marrow aspirate/CFS are taken and studied for cytogenetic/immunophenotype characteristics (see later in the protocol how the results of these tests might effect the treatment.)

SR ALL is treated on AALL0331, as outlined below. HR ALL is treated on AALL0232. The protocols for infant, T-cell, and very high risk will be added to this site when they are available.


AALL0331

Patients are assigned to one of three groups of SR (Standard Risk) level, called SR-low, SR-average, and SR-high. (Historically, the POG 9904 and 9905 trials also defined different levels of average/low risk - activated early 2000s and still active 2005 - while CCG 1991 lumped these lower-risk groups together.) Remember: this trial is for 0-9 year olds, WBC less than 50K at diagnosis, and pre-B ALL. MRD levels direct the treatment to some extent (details below).

SR-low:

SR-average

SR-high (this is not a randomized arm)

A patient must go to a higher risk protocol if they have:


Induction, 4 weeks

(Same induction for low-, average-, and high-risk arms.)

All patients receive:

Day 29: Patients are assessed for response to treatment on by doing a traditional bone marrow assessment (giving the M1, M2, M3 value) and by testing for MRD (minimal residual disease, a more sensitive leukemia test).

Extended induction therapy:

Patients with M1 bone marrow and MRD and less than 1% after extended induction therapy proceed to consolidation therapy as standard-risk-high patients. Patients with M2 or M3 bone marrow after extended induction therapy are removed from the study.

SR-low regimens for consolidation, interim maintenance, and delayed intensification

Patients are randomized to one of two treatment arms. One is the standard arm (LRS Arm), and one has increased asparaginase (4 additional doses) LRAsp Arm).

Standard consolidation therapy

Standard interim maintenance therapy

Standard delayed intensification therapy

Experimental consolidation therapy (additional pegaspargase)

Experimental interim maintenance therapy (additional pegaspargase)

Experimental delayed intensification therapy

Patients receive the same - standard - therapy as in the non-increased-asparaginase arm:


SR-average regimens for consolidation, interim maintenance, and delayed intensification

Patients are randomized to 1 of 4 treatment arms:

Arm I: SR-average

Standard consolidation therapy

Standard interim maintenance therapy

Standard delayed intensification therapy

Arm II: SR-average

Standard consolidation therapy

Augmented interim maintenance therapy

Augmented delayed intensification therapy

Arm III: SR-average

Augmented consolidation therapy

Standard interim maintenance therapy

Standard delayed intensification therapy

Arm IV SR-average

Augmented consolidation therapy

Augmented interim maintenance therapy

Augmented delayed intensification therapy


SR-high

There is no randomization for the high risk group.

Augmented consolidation therapy

Patients with testicular disease at diagnosis also undergo bilateral testicular radiotherapy once daily, 5 days a week, for approximately 2.5 weeks.

Double delayed intensification. The following interim maintenance and delayed intensification is repeated once:

Augmented interim maintenance therapy

Augmented delayed intensification therapy

Patients with CNS3 disease at diagnosis also undergo cranial radiotherapy on days 29-33 and 36-40 during course 2 only.


Maintenance therapy, all arms, all risk levels

Maintenance:

Each course of maintenance proceeds as outlined below. Courses repeat every 84 days for a total of 2 years from the start of interim maintenance therapy for female patients and 3 years from the start of interim maintenance therapy for male patients.


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Last Updated 4/06

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