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Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma


Description

This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.PRIMARY OBJECTIVES: I. To determine the complete remission (CR) rate and progression-free survival following treatment with hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (hyper-CVAD) in combination with nelarabine in previously untreated patients with T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma. II. To determine the safety and overall survival of previously untreated pat

Trial Eligibility

Inclusion Criteria: * Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =\< 2 courses are also eligible * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 * Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN) * Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable Exclusion Criteria: * Pregnant or nursing women

Study Info

Organization

M.D. Anderson Cancer Center


Primary Outcome

Complete remission rate


Outcome Timeframe 3 years

NCTID NCT00501826

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2007-07-11

Completion Date 2026-10-31

Enrollment Target 160

Interventions

DRUG Cyclophosphamide

DRUG Cytarabine

DRUG Dexamethasone

DRUG Doxorubicin Hydrochloride

DRUG Mercaptopurine

DRUG Methotrexate

DRUG Nelarabine

DRUG Pegaspargase

DRUG Prednisone

DRUG Venetoclax

DRUG Vincristine Sulfate

Locations Recruiting

M D Anderson Cancer Center

United States, Texas, Houston


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