Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
28

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
Type
Interventional
Phase
Phase 2
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 examine the potential efficacy of DA-EPOCH as front-line therapy for adults with acute lymphoblastic leukemia/lymphoma (ALL). SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of this regimen. II. To evaluate the progression-free (PFS) and overall survival (OS...

PRIMARY OBJECTIVES: I. To examine the potential efficacy of DA-EPOCH as front-line therapy for adults with acute lymphoblastic leukemia/lymphoma (ALL). SECONDARY OBJECTIVES: I. To evaluate the safety and feasibility of this regimen. II. To evaluate the progression-free (PFS) and overall survival (OS) of patients after receiving DA-EPOCH for newly-diagnosed ALL. III. To explore for novel genetic/genomic biomarkers of prognosis and response to treatment in adults with ALL. IV. To compare outcomes predicted by the presence or absence of minimal residual disease (MRD) as determined by either multiparameter flow cytometry (MFC) or high-throughput sequencing (HTS). OUTLINE: Patients receive etoposide intravenously (IV) over 96 hours, doxorubicin IV over 96 hours, and vincristine sulfate IV over 96 hours on days 1-4. Patients also receive cyclophosphamide IV over 1 hour on day 5 and prednisone orally (PO) twice a day (BID) on days 1-5. Patients with disease features that predict sensitivity to ABL kinase inhibitors (e.g., Philadelphia Chromosome positive (Ph+) [i.e., t(9;22)]; rearrangements involving PDGFRA, PDGFRB, ABL2, or other genetic lesions that activate kinase receptor signaling): imatinib mesylate or dasatinib PO once per day (QD) on days 1-14. The decision to add imatinib or dasatinib will be left to the treating physician and will be based on the available scientific literature to support the sensitivity of genomic alterations to these TKIs. Patients who are CD20+ also receive rituximab IV on day 1 or day 5. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and every 6 months for 3 years.

Tracking Information

NCT #
NCT03023046
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ryan D. Cassaday Fred Hutch/University of Washington Cancer Consortium