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

Secura Bio

Status and phase: Terminated; Phase 2; Phase 1

Conditions: CD20+ Follicular Lymphoma

Treatments: Drug: Duvelisib; Drug: Obinutuzumab; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391545

IPI-145-19

2014-005459-13 (EudraCT Number)

Details and patient eligibility

About

A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

Full description

This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.

The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Duvelisib and Rituximab

Experimental group

Description:

Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.

Treatment:

Drug: Rituximab

Drug: Duvelisib

Duvelisib and Obinutuzumab

Experimental group

Description:

Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.

Treatment:

Drug: Obinutuzumab

Drug: Duvelisib