MDACC Study Summary COGAALL0232

Study Summary
No. COGAALL0232:.......Leukemia......Michael E. Rytting......Pediatrics

Study Summary Title



Study Summary Number:	COGAALL0232

Study Title:	High Risk B-precursor Acute Lymphoblastic Leukemia ALL

Physician

New Patient Referral



Name:	Michael E. Rytting	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Induction (29 days) - weekly Consolidation (56 days) - 4days/week IM 1 (56 days) - q 10days; (63 days) - q 2 wks & MTX levels DI 1 (56 days) - weekly & QD for ARAC IM 2 (56 days) - q 10days DI 2 (56 days) - weekly & QD for ARAC Maintenance - weekly

Treatment Agents:	6-MP 6-Thioguanine Crisantaspase Cyclophosphamide Cytarabine Daunorubicin Dexamethasone Doxorubicin Leucovorin Methotrexate PEG-L-Asparaginase Prednisone Vincristine	Home Care:	Dexamethasone, PEG Asparaginase, Prednisone, Cytarabine, Mercaptopurine, Thioguanine, and oral Methotrexate may be given at home

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Hospitalizations will lasts about 7 days at initial diagnosis; depending on treatment arm, pts who receive HD MTX may be hospitalized for 2-4 days.

Description/
Intervention:

The overall goal of this study is to see if researchers can improve patient
response to therapy in High Risk ALL without increasing the side effects of
therapy. Researchers want to find out if using dexamethasone instead of
prednisone during the first month of treatment can improve overall survival
rates without causing more side effects. Researchers want to find out if using
high doses of methotrexate (instead of starting at lower doses of methotrexate
and slowly raising the dose level over time) can keep the cancer from returning
without causing more serious side effects. Researchers would also like to see
if how quickly participants respond to initial therapy (reach disease
remission) and if how well they do following treatment can be linked to the
number of leukemia cells in the bone marrow after the first month of treatment.

Study Objectives / Outcomes

1. To improve the outcome of children with high risk acute lymphoblastic leukemia.
2. To determine the relative safety and efficacy of dexamethasone given for 14 days versus prednisone given for 28 days during Induction.
3. To determine the relative safety and efficacy of high dose methotrexate (5 gm/m2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue (Capizzi I) delivered during Interim Maintenance I.
4. To correlate Day 29 Minimal Residual Disease (MRD) with Event Free Survival (EFS) and Overall Survival (OS).
5. To correlate early marrow response status with Day 29 MRD status.
6. To improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented BFM.

Study Status Information



Study Activation / Registration Date:	10/03/2005

IRB Review and Approval Date:	06/15/2005

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	2964

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must be eligible for and enrolled on COGAALL03B1.

2) Patients must be greater than 1 and less than 31 years of age.

3) Patients must have newly diagnosed B-precursor ALL.

4) WBC Criteria: a) Age 1.000-9.999 years: WBC > or = 50,000/�L. b) Age 10.000-30.999 years: Any WBC. c) Prior steroid therapy: Any WBC. d) Testicular disease: Any WBC

5) Intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. (Note: The CNS status must be determined based on a sample obtained prior toadministration of any systemic or intrathecal chemotherapy, except for steroid pretreatment Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.

6) Patients receiving prior steroid therapy (as described in COGAALL03B1) are eligible for study.

7) All patients and/or their parents or legal guardians must sign a written informed consent.

8) All institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

1) Patients who have had prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine.

2) Patients with Down syndrome are ineligible to enroll onto this study.

Links

Registration Number: NCT00075725
Study Information on Clinical Trials Registry (clinicaltrials.gov)