Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
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| ClinicalTrials.gov Identifier: NCT00501826 |
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Recruitment Status :
Recruiting
First Posted : July 16, 2007
Last Update Posted : January 13, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma | Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Hydrochloride Drug: Mercaptopurine Drug: Methotrexate Drug: Nelarabine Drug: Pegaspargase Drug: Prednisone Drug: Venetoclax Drug: Vincristine Sulfate | Phase 2 |
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 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma |
| Actual Study Start Date : | July 11, 2007 |
| Estimated Primary Completion Date : | October 31, 2023 |
| Estimated Study Completion Date : | October 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (nelarabine and combination chemotherapy)
See Detailed Description
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Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine Given IV
Other Names:
Drug: Dexamethasone Given IV or PO
Other Names:
Drug: Doxorubicin Hydrochloride Given IV
Other Names:
Drug: Mercaptopurine Given PO
Other Names:
Drug: Methotrexate Given IV and PO
Other Names:
Drug: Nelarabine Given IV
Other Names:
Drug: Pegaspargase Given IV
Other Names:
Drug: Prednisone Given PO
Other Names:
Drug: Venetoclax Given PO
Other Names:
Drug: Vincristine Sulfate Given IV
Other Names:
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- Complete remission rate [ Time Frame: 3 years ]The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.
- Duration of remission [ Time Frame: Up to 9 years ]Duration of remission will be evaluated.
- Progression-free survival [ Time Frame: 3 years ]Progression-free survival will be estimated.
- Overall survival [ Time Frame: 3 years ]Overall survival will be estimated.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501826
| Contact: Farhad Ravandi-Kashani, MD | 713-745-0394 |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Farhad Ravandi-Kashani 713-745-0394 | |
| Principal Investigator: Farhad Ravandi-Kashani | |
| Principal Investigator: | Farhad Ravandi-Kashani | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501826 |
| Other Study ID Numbers: |
2006-0328 NCI-2012-01518 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2006-0328 ( Other Identifier: M D Anderson Cancer Center ) |
| First Posted: | July 16, 2007 Key Record Dates |
| Last Update Posted: | January 13, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine 6-methoxypurine arabinoside Dexamethasone |
Dexamethasone acetate Prednisone Cortisone Cyclophosphamide Doxorubicin Liposomal doxorubicin Methotrexate Vincristine Venetoclax Asparaginase Mercaptopurine Pegaspargase BB 1101 Immunosuppressive Agents Immunologic Factors |