MDACC Study Summary COGAALL0331

Study Summary
No. COGAALL0331:.......Leukemia; Pediatrics......Cesar Nunez......Pediatrics

Study Summary Title



Study Summary Number:	COGAALL0331

Study Title:	Standard Risk B-precursor Acute Lymphoblastic Leukemia

Physician

New Patient Referral



Name:	Cesar Nunez	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 Pediatrics	Supported By:	The Children's Oncology Group (COG) through the National Cancer Institute

Phase of Study:	Phase III	Return Visit:	Per treatment plan, then for follow-up visits: a) q 4-8 wks during 1st year post therapy b) q 2 mos during 2nd year off-treatment c) q 3 mos during 3rd year off-treatment d) q 6 mos during 4th year off-treatment e) q 6-12 mos during 5th year off-treatment

Treatment Agents:	6-mercaptopurine 6-Thioguanine Asparaginase Cyclophosphamide Cytarabine Daunorubicin Dexamethasone Doxorubicin Leucovorin Methotrexate Pegasparagase Vincristine Sulfate	Home Care:	During certain phases, Dexamethasone, Mercaptopurine, Methotrexate, and Thioguanine may be given at home.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Patients will receive all IV, IT, and IM chemotherapy in the hospital or in the clinic. Additional hospitalizations will be necessary during periods of febrile neutropenia, fever, and possibly for other illnesses.

Description/
Intervention:

The overall goal of this study is to see if researchers can get rid of the
cancer for as long as possible with acceptable side effects.

The goal of Part I of this study is to collect information about your leukemia
and about the effects of the first phase of treatment (called Induction), which
will last about 5-7 weeks, depending on your response to treatment.
Participants (people participating in the study) will receive a standard
treatment plan during Part I of this study. The standard treatment and tests
are described in Section 3 of this consent.

Study Objectives / Outcomes

Primary Objectives
1. Prior to Amendment #2C: To determine whether the substitution of three intensified phases of post-induction treatment for standard phases will improve the event free survival (EFS) of children with SR-average acute lymphoblastic leukemia (ALL).

2. With Amendment #2C: To determine whether the substitution of intensified Consolidation for standard Consolidation will improve the event free survival (EFS) of children with SR-average acute lymphoblastic leukemia (ALL).

Secondary Objectives

1. To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.

2. To determine the critical time periods when future intervention studies to mitigate adverse HRQOL outcomes should occur. (MD Anderson Cancer Center is not participating in the HRQOL ancillary study of this protocol)

3. To correlate Day 29 Minimal Residual Disease (MRD) with EFS and Overall Survival (OS).

4. To correlate early marrow response status with Day 29 MRD status.

5. To improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented BFM.

6. To examine the relative contributions of genetic factors and early treatment response to outcome by comparing the outcome of patients with and without TEL-AML1 fusion or triple trisomy and low levels of MRD at end Induction who are treated with identical therapy on the standard arms of the SR-low and SR-average trials.

Study Status Information



Study Activation / Registration Date:	11/10/2005

IRB Review and Approval Date:	07/20/2005

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	3381

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) Prior to study enrollment, all patients must have been registered via the eRDE system into the COG Cancer Registry (Diagnosis/Registry).

2) Study enrollment must take place within five (5) calendar days of beginning protocol therapy. If enrollment takes place before starting therapy, the date protocol therapy is projected to start must be no later than five (5) calendar days after enrollment. Tests to determine eligibility must be performed within one week prior to enrollment unless otherwise indicated below.

3) Patients must be enrolled on COGAALL03B1 BEFORE TREATMENT BEGINS (with the exception of the first dose of intrathecal chemotherapy or selected cases of steroid pretreatment). PATIENTS THAT BEGIN PROTOCOL THERAPY ON THIS STUDY PRIOR TO ENROLLMENT ON AALL03B1 ARE INELIGIBLE FOR BOTH AALL0331 AND AALL0232.

4) Patients must be > 1 year and < 10 years of age.

5) Initial white blood cell count must be < 50,000/�l.

6) Patients must have newly diagnosed B-precursor ALL.Patients with Down syndrome are also eligible. Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232.

7) Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine.

8) A parent or legal guardian must sign a written informed consent/parental permission for all patients.

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

Exclusion Criteria:

1) Patients < 1 and > / = 10 years of age.

2) Patients with initial WBC > 50,000/�L.

Links

Registration Number: NCT00103285
Study Information on Clinical Trials Registry (clinicaltrials.gov)