Recruitment

Recruitment Status
Completed
Estimated Enrollment
250

Inclusion Criteria

Patient has Ann Arbor stage III or IV disease.
Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
...
Patient has Ann Arbor stage III or IV disease.
Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
greater than 1.5 cm in the longest dimension or
Patient is male or female older than 18 years.
between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis

Exclusion Criteria

Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose
Patient has known central nervous system involvement.
...
Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose
Patient has known central nervous system involvement.
Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
All doses of corticoid therapy for treatment of NHL
Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.

Summary

Conditions
Lymphoma, Follicular
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patient has Ann Arbor stage III or IV disease.
Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
...
Patient has Ann Arbor stage III or IV disease.
Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
greater than 1.5 cm in the longest dimension or
Patient is male or female older than 18 years.
between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis

Exclusion Criteria

Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose
Patient has known central nervous system involvement.
...
Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose
Patient has known central nervous system involvement.
Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
All doses of corticoid therapy for treatment of NHL
Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.

Tracking Information

NCT #
NCT02162771
Collaborators
Not Provided
Investigators
Not Provided