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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