Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501826
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2007-07-12
Brief Title:
Combination Chemotherapy and Nelarabine in Treating Patients with T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 methotrexatecytarabine 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 methotrexatecytarabine 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
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 methotrexatecytarabine 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 methotrexatecytarabine 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-0328 | OTHER | M D Anderson Cancer Center | None |
| NCI-2012-01518 | REGISTRY | None | None |