Veliparib and Temozolomide in Treating Patients With Acute Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
- Alkylating Agent-Related Acute Myeloid Leukemia
- Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
- Chronic Myelomonocytic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Adult Acute Promyelocytic Leukemia With PML-RARA
- Adult B Acute Lymphoblastic Leukemia
- Secondary Acute Myeloid Leukemia
- Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Recurrent Adult Acute Myeloid Leukemia
- Adult T Acute Lymphoblastic Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To define the maximum-tolerated dose (MTD) and recommended phase II dose of ABT-888 (veliparib) administered in combination with temozolomide in patients with acute leukemias. II. To evaluate the feasibility, safety, and toxicity of administering ABT-888 in combination with te...
PRIMARY OBJECTIVES: I. To define the maximum-tolerated dose (MTD) and recommended phase II dose of ABT-888 (veliparib) administered in combination with temozolomide in patients with acute leukemias. II. To evaluate the feasibility, safety, and toxicity of administering ABT-888 in combination with temozolomide in patients with acute leukemias. SECONDARY OBJECTIVES: I. To document response in acute leukemias. II. To observe the pharmacokinetics of both ABT-888 and temozolomide when administered alone and in combination. III. To study the pharmacodynamics to determine the levels of poly(ADP-ribose) (PAR) before and after administration of ABT-888 and temozolomide in patient leukemia blasts, to analyze methyl-guanine methyl-transferase (MGMT) protein levels in primary leukemia blasts, and to quantify the induction of gamma-H2A histone family, member X (y-H2AX) and RAD51 recombinase (RAD51) foci in patient leukemia blasts after treatment. OUTLINE: This is a dose-escalation study of veliparib. Patients receive veliparib orally (PO) once daily (QD) on day 1 and twice daily on days 4-12 and temozolomide PO QD on days 3-9 of course 1. Beginning at least 30 days after the start of treatment, patients receive veliparib PO twice daily (BID) on days 1-8 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission receive 5 more courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Tracking Information
- NCT #
- NCT01139970
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ivana Gojo Johns Hopkins University/Sidney Kimmel Cancer Center
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