Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent Marginal Zone Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Recurrent Grade 3a Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Grade 1 Follicular Lymphoma
  • Refractory Grade 2 Follicular Lymphoma
  • Refractory Grade 3a Follicular 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 OBJECTIVE: I. To evaluate the end of induction (EOI) complete response rate (CR) for treatment with the regimen of rituximab and hyaluronidase human + polatuzumab vedotin + venetoclax (RSC + Pola + Ven) in relapsed/refractory mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. To evaluate t...

PRIMARY OBJECTIVE: I. To evaluate the end of induction (EOI) complete response rate (CR) for treatment with the regimen of rituximab and hyaluronidase human + polatuzumab vedotin + venetoclax (RSC + Pola + Ven) in relapsed/refractory mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. To evaluate the EOI overall response rate (ORR) for the combination of RSC + Pola + Ven in relapsed/refractory MCL. II. To evaluate the best response (CR, partial response [PR]) in patients who continue on to maintenance therapy and evaluate the improvement in the depth of response. III. To evaluate the progression free survival (PFS) and overall survival (OS) for the combination of RSC + Pola + Ven) in relapsed/ refractory MCL. IV. To compare the ORR, CR, PFS, and OS in ibrutinib refractory compared to ibrutinib naive patients. V. To evaluate regimen-related toxicity for patients treated with RSC + Pola + Ven. CORRELATIVE RESEARCH OBJECTIVES: I. To evaluate changes in minimal residual disease (MRD) status in both responding and non-responding patients at EOI and end of maintenance and compared to baseline as well as correlate MRD status with PFS and OS. II. To evaluate changes in systemic immune profiles and T cell activation induced by treatment with RituxSC (RSC) + Pola + Ven. III. To evaluate the prognostic importance of high risk cytogenetic alterations, and other risk stratification scores in patients with relapsed/refractory MCL receiving RituxSC + Pola + Ven. OUTLINE: INDUCTION: Patients receive rituximab intravenously (IV) on day 1 of cycle 1 and rituximab and hyaluronidase human subcutaneously (SC) over 5 minutes on day 1 of cycles 2-6. Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 and venetoclax orally (PO) daily on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive venetoclax PO daily and rituximab and hyaluronidase human SC over 5 minutes every 60 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 90 days for up to 5 years.

Tracking Information

NCT #
NCT04659044
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Catherine S Diefenbach Academic and Community Cancer Research United