Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00501826 |
| Other study ID # |
2006-0328 |
| Secondary ID |
NCI-2012-0151820 |
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2007 |
| Est. completion date |
October 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
Farhad Ravandi-Kashani, MD |
| Phone |
713-745-0394 |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 (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.
