RecruitingPhase 2NCT00501826

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

160 participants

Start Date

Jul 11, 2007

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria5

  • 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 Criteria1

  • Pregnant or nursing women

Interventions

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IV

DRUGDexamethasone

Given IV or PO

DRUGDoxorubicin Hydrochloride

Given IV

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IV and PO

DRUGNelarabine

Given IV

DRUGPegaspargase

Given IV

DRUGPrednisone

Given PO

DRUGVenetoclax

Given PO

DRUGVincristine Sulfate

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT00501826


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