A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia
City of Hope Medical Center
Summary
This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which 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. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.
Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability of combining venetoclax with the C10403 regimen backbone during induction and consolidation in newly diagnosed adults with B cell acute lymphoblastic leukemia (ALL). II. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose/schedule (RP2D) of venetoclax in combination with the C10403 regimen. SECONDARY OBJECTIVES: I. To estimate complete response (CR) after induction. II. To estimate composite CR (CR or CR with incomplete hematologic recovery \[CRi\] or CR with partial hematologic recovery \[CRh\]) after…
Eligibility
- Age range
- 18–54 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Age between 18 and 54 years * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Histologically confirmed B-cell ALL according to World Health Organization criteria * Note: Lymphoblastic leukemia is included as long as there is bone marrow involvement * Newly diagnosed disease with \>= 5% blasts in the marrow * White blood cell count less than 25 x 10\^9/L prior to initiation of venetoclax. Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prio…
Interventions
- DrugCyclophosphamide
Given IV
- DrugCytarabine
Given SC, IV or IT
- DrugDaunorubicin Hydrochloride
Given IV
- DrugMercaptopurine
Given PO
- DrugMethotrexate
Given IT
- DrugPegaspargase
Given IM or IV
- DrugPrednisone
Given PO
Location
- City of Hope Medical CenterDuarte, California