Trial Search Results

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

We hope to learn how effective and safe the investigational drug IPI-145 is when given together with one of two other drugs, obinutuzumab and rituximab, to patients with follicular lymphoma (FL).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Verastem, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Duvelisib
  • Drug: Rituximab
  • Drug: Obinutuzumab

Phase:

Phase 1/Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting