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A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Not Recruiting
Trial ID: NCT02391545
Purpose
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or
Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
Official Title
A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Stanford Investigator(s)
Hans-Christoph Becker, MD, FSABI, FSCCT
Clinical Professor, Radiology
Neel K. Gupta
Clinical Associate Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Eligibility
Inclusion Criteria:
- Diagnosis of CD20+, follicular lymphoma that has not been treated
- CD20-immunophenotyping of tumor to document B-cell follicular lymphoma
- Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease
- Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF
criteria)
- At least one measurable lesion that is > 1.5 cm in at least one dimension
- Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to
Karnofsky Performance Status [KPS] >=60%)
Exclusion Criteria:
- Received systemic treatment for lymphoma such as chemotherapy, immunotherapy,
radiotherapy, investigational agents, or radioimmunotherapy.
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade
3B follicular lymphoma
- Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine
protein, or known hypersensitivity to any of the study drugs
- Prior allogeneic hematopoietic stem cell transplant
- Prior, current or chronic hepatitis B or hepatitis C infection
- Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1
(HTLV-1) infection
Intervention(s):
drug: Rituximab
drug: Obinutuzumab
drug: Duvelisib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061