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A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib (NSC-732517) , Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
65 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCT ID
NCT02143414
Protocol IDs
S1318 (primary)
NCI-2014-01047
SWOG-S1318
Study Sponsor
National Cancer Institute

Summary

This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.

Objectives

PRIMARY OBJECTIVES:

I. To evaluate the 3-year survival rate in elderly patients with newly diagnosed Philadelphia (Ph)-negative acute lymphoblastic leukemia (ALL) treated with blinatumomab followed by POMP (prednisone, vincristine sulfate, methotrexate, and mercaptopurine) maintenance.

II. To evaluate in a preliminary manner (feasibility study) the safety of dasatinib-steroid based induction followed by blinatumomab treatment in combination with dasatinib followed by dasatinib-based maintenance in elderly patients with newly diagnosed Ph-positive ALL.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in these patient populations treated with these regimens.

II. To estimate the rates of complete response (CR), complete remission with incomplete count recovery (CRi) and disease-free survival in Ph-negative patients.

III. To estimate disease-free and overall survival in elderly Ph-positive patients.

IV. To estimate in each cohort the rate of minimal residual disease (MRD) negativity, and the time to achieve MRD negativity (exploratory analysis).

V. To determine whether anti-idiotype antibodies directed against blinatumomab develop with blinatumomab treatment in this study.

OUTLINE: Patients are assigned to 1 of 2 treatment cohorts according to Philadelphia chromosome status.

COHORT I (PHILADELPHIA CHROMOSOME NEGATIVE PATIENTS):

INDUCTION: Patients receive blinatumomab intravenously (IV) continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION: Patients not achieving CR or CRi after Induction, receive blinatumomab IV continuously over 24 hours on days 1-28 in the absence of disease progression or unacceptable toxicity.

POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive prednisone orally (PO) on days 1-5, vincristine sulfate IV on day 1, mercaptopurine PO on days 1-28, and methotrexate PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity.

COHORT II (PHILADELPHIA CHROMOSOME POSITIVE PATIENTS):

INDUCTION: Patients receive dasatinib PO twice daily (BID) on days 1-84 and prednisone PO on days 1-24 with tapering on days 25-32 in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity.

POST-REMISSION: Patients receive blinatumomab IV continuously over 24 hours on days 1-28 and dasatinib PO once daily (QD) on days 1-42. Treatment repeats every 42 days for 3 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive dasatinib PO BID on days 1-28 and prednisone PO on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually until 10 years from initial registration.

Treatment Sites in Georgia

Augusta University Medical Center


1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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