Recruiting
Phase 2

Combination Chemotherapy & Nelarabine

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00501826

Conditions

T Acute Lymphoblastic Leukemia

T Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Cytarabine

Dexamethasone

Doxorubicin Hydrochloride

Mercaptopurine

Study Details

Brief 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.

Conditions

T Acute Lymphoblastic Leukemia

T Lymphoblastic Lymphoma

Study ID

NCT00501826

Start date

Jul 11, 2007

Status verified date

Jul, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (nelarabine and combination chemotherapy)

See Detailed Description

Interventions

Cyclophosphamide

Given IV

Cytarabine

Given IV

Dexamethasone

Given IV or PO

Doxorubicin Hydrochloride

Given IV

Mercaptopurine

Given PO

Methotrexate

Given IV and PO

Nelarabine

Given IV

Pegaspargase

Given IV

Prednisone

Given PO

Venetoclax

Given PO

Vincristine Sulfate

Given IV

Primary outcome measure

  • Complete remission rate [ Time Frame: 3 years ]
  • Duration of remission [ Time Frame: Up to 9 years ]
  • Progression-free survival [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Farhad Ravandi-Kashani, MD

713-745-0394

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Farhad Ravandi-Kashani

713-745-0394

Principal Investigator:

Farhad Ravandi-Kashani

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.