CD20+ Follicular Lymphoma Clinical Trial
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)
| Verified date | September 2023 |
| Source | SecuraBio |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
| Status | Terminated |
| Enrollment | 55 |
| Est. completion date | May 2017 |
| Est. primary completion date | January 17, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| SecuraBio |
United States, Belgium, France, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 | 28 days from first dose of study treatment | ||
| Primary | Complete Response Rate (CRR)- Part 2 | Up to 2 years from the first dose of study treatment | ||
| Secondary | Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values | Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3. | Up to 30 days after the last dose of study treatment | |
| Secondary | Overall Response Rate (ORR) | Up to 2 years from the first dose of study treatment | ||
| Secondary | Duration of Response (DOR) | The median DOR was non-estimable. | Up to 2 years from the first dose of study treatment | |
| Secondary | Overall Survival (OS) | Up to 2 years from the first dose of study treatment | ||
| Secondary | Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite) | Plasma concentrations of Duvelisib and IPI-656 (metabolite) | Every 4 weeks for 16 weeks |