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A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia

NCT02733042 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-11-18

Study results available
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Summary

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

Conditions

  • Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

DRUG

Durvalumab

Administered as an IV infusion (250 mL) over approximately 1 hour in duration

DRUG

Lenalidomide

Administered orally

DRUG

Rituximab

Administered by intravenous infusion

DRUG

Ibrutinib

Administered orally

DRUG

Bendamustine

Administered as a 30-minute intravenous infusion

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2019-03-06
Completion
2022-08-21

Countries

  • United States
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733042 on ClinicalTrials.gov