Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Completed · Not applicable

Conditions studied: T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia

In brief

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia

Key facts

Study ID: NCT00016302
Run by: National Cancer Institute (NCI)
People needed: 100
Starts: 2001-04-01
Last updated by the study team: 2013-01-16

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
High-risk disease, defined as meeting at least 1 of the following criteria:
WBC at least 50,000/mm\^3
Age 10 years or over
Patients with WBC at least 25,000/mm\^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
Concurrent registration to POG 9900 within the past 8 days required
Performance status - Karnofsky 50-100% (over 10 years of age)
Performance status - Lansky 50-100% (10 years of age and under)
See Disease Characteristics
Bilirubin no greater than 1.5 mg/dL
SGPT less than 5 times normal
Creatinine normal
Creatinine clearance or glomerular filtration rate at least 60 mL/min
No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
Not pregnant or nursing
Fertile patients must use effective contraception
No prior biologic therapy
No more than 72 hours since prior intrathecal cytarabine
No other prior chemotherapy
Prior steroids allowed
No chronic steroid treatment for another disease
Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed

Where it is running

Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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