Study:
Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma
Rationale:
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.
Purpose:
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.
Study Status: Recruiting
Recruiting:
Tanya M. Tekautz 866-223-8100
| Condition |
Intervention |
Phase |
Contiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Stage II Childhood Lymphoblastic Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Childhood Lymphoblastic Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Childhood Lymphoblastic Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia |
Drug: doxorubicin hydrochloride
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: prednisone
Drug: pegaspargase
Drug: methotrexate
Drug: leucovorin calcium
Drug: cyclophosphamide
Drug: mercaptopurine
Drug: nelarabine
Drug: asparaginase
Drug: dexamethasone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
Other: laboratory biomarker analysis |
Phase 3 |
Verified by
National Cancer Institute (NCI)
March, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00408005
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Stuart Winter., Principal Investigator