Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
60

Summary

Conditions
  • Ann Arbor Stage II Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage II Grade 1 Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma
  • Bulky Disease
  • Fatigue
  • Splenomegaly
  • Weight Loss
  • Fever
  • Grade 3a Follicular Lymphoma
  • Night Sweats
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 evaluate the efficacy of obinutuzumab combined with lenalidomide in patients with previously untreated follicular lymphoma (FL) (determined by progression-free survival [PFS] at 2 years). SECONDARY OBJECTIVES: I. To evaluate the safety of obinutuzumab in combination with le...

PRIMARY OBJECTIVES: I. To evaluate the efficacy of obinutuzumab combined with lenalidomide in patients with previously untreated follicular lymphoma (FL) (determined by progression-free survival [PFS] at 2 years). SECONDARY OBJECTIVES: I. To evaluate the safety of obinutuzumab in combination with lenalidomide in patients with untreated follicular lymphoma. II. To evaluate the efficacy of obinutuzumab in combination with lenalidomide in subjects with follicular lymphoma as assessed by complete remission (CR) at 30 months, overall response rate (ORR), duration of response (DOR), event free survival (EFS), and overall survival (OS). EXPLORATORY OBJECTIVES: I. To evaluate prognostic and predictive biomarkers relative to treatment outcomes. OUTLINE: Patients receive obinutuzumab intravenously (IV) over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of courses 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or complete remission unconfirmed (CRu) may receive up to an additional 12 courses of lenalidomide. After completion of study treatment, patients are followed up every 6 months for 18 months and then every year for up to 2 years.

Tracking Information

NCT #
NCT02871219
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Loretta J Nastoupil M.D. Anderson Cancer Center