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

Conditions

• CD20+ Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Duvelisib — DRUG
  PI3K Inhibitor
• Rituximab — DRUG
  monoclonal antibody
• Obinutuzumab — DRUG
  monoclonal antibody

Study Details

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

Key Dates

Start date

Dec 31, 2014

Status verified

Sep 2023

Primary completion

Jan 17, 2017

Completion

May 31, 2017

Study Design

Enrollment

55 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Duvelisib and Rituximab
  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.
• Experimental: Duvelisib and Obinutuzumab
  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.

Primary Outcome Measure

Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 [ Time Frame: 28 days from first dose of study treatment ]

Locations (5)