Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT ID: NCT00501826
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2007-07-11
2026-10-31
Brief Summary
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Detailed Description
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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 patients with T-cell ALL and T-cell lymphoblastic lymphoma.
III. To determine the safety and efficacy of adding pegaspargase to the regimen.
IV. To determine the safety and efficacy of adding venetoclax to the regimen.
OUTLINE:
COURSES 1, 3, 5, and 7 (hyper-CVAD): Patients receive cyclophosphamide intravenously (IV) over 3 hours twice daily (BID) on day 1-3, doxorubicin IV over 24 hours on day 4, vincristine IV over 15-30 minutes on days 4 and 11, and dexamethasone IV or orally (PO) once daily (QD) on days 1-4 and 11-14.
COURSES 2, 4, 6, and 8 (methotrexate/cytarabine): Patients receive methotrexate IV over 24 hours on day 1 and cytarabine IV over 2 hours BID on days 2 and 3.
Patients also receive venetoclax PO QD on days 1-14 of each course. Courses of hyper-CVAD and methotrexate/cytarabine repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also receive nelarabine IV over 2 hours once daily (QD) for 5 days and pegaspargase IV over 2 hours on day 5 after completion of course 4 and after the completion of course 5 in the absence of disease progression or unacceptable toxicity.
MAINTENANCE COURSES 1-5, 8-17, and 20-30 (mercaptopurine, vincristine, methotrexate, and prednisone \[POMP\]): Patients receive mercaptopurine PO thrice daily (TID), methotrexate PO once weekly, vincristine sulfate IV on day 1, prednisone PO QD on days 1-5, and venetoclax PO QD on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
INTENSIFICATION COURSES 6 and 7: Patients receive nelarabine IV QD over 2 hours on days 1-5 and pegaspargase IV over 2 hours on day 5. Patients also receive venetoclax PO QD on days 1-14. Courses repeat every 21-35 days in the absence of disease progression or unacceptable toxicity.
INTENSIFICATION COURSES 18 and 19: Patients receive methotrexate IV over 2 hours on day 1, pegaspargase IV over 2 hours on day 2, and venetoclax PO QD on days 1-14 in the absence of disease progression or unacceptable toxicity.
POMP maintenance therapy continues for 30 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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Treatment (nelarabine and combination chemotherapy)
See Detailed Description
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Farhad Ravandi-Kashani
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Farhad Ravandi-Kashani, MD
Role: CONTACT
Facility Contacts
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Farhad Ravandi-Kashani
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2012-01518
Identifier Type: REGISTRY
Identifier Source: secondary_id
2006-0328
Identifier Type: OTHER
Identifier Source: secondary_id
2006-0328
Identifier Type: -
Identifier Source: org_study_id
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