A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

Trial ID or NCT#

NCT02391545

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Hans-Christoph Becker, MD, FSABI, FSCCT
Radiologist
Clinical Professor, Radiology
Neel K. Gupta
Neel K. Gupta
Hematologist-Oncologist
Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061