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COG-AALL0434

Trial

Clinical Trial Title

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Trial Status

Closed to Enrollment

Start Date

April 16, 2007

Trial Type

Pediatric Cancer (Oncology)

Specific Condition

T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-cell Lymphoblastic Lymphoma (T-NHL)

Description

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Eligibility Criteria

Patients with T-ALL must be enrolled on COG AALL08B1 (Classification Study) prior to enrollment on AALL0434

Patients with T-NHL can enroll directly on AALL0434 (enrollment on COG AALL08B1, Classification Study, is not required)

Age: >1 and <31 years of age

Diagnosis: newly diagnosed T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-Lineage Lymphoblastic Lymphoma (T-NHL) Stage II-IV

No prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine

Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive Nelarabine*

Patients with pre-existing Grade 2 or greater peripheral neurotoxicity determined prior to Induction treatment are not eligible to receive Nelarabine*

Patients with Down syndrome are not eligible for this study

CNS3-Positive T-NHL patients are not eligible for this study

*these restrictions in eligibility are designed to prevent excessive Nelarabine-induced central and peripheral neurotoxicity in at-risk patients; includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years.

Notes

https://clinicaltrials.gov/ct2/show/NCT00408005 

Study status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Principal Investigator Name

Janice Olson, MD

Contact Name

Children's Cancer and Blood Disorders Program

Phone

(503) 276-9300

Last Updated: Wednesday, January 27, 2021 11:41:01 AM