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
Neel K. Gupta

Clinical Associate Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology

Lauren Maeda
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

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