ACTIVE_NOT_RECRUITING

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Official Title

A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).

Quick Facts

Study Start:2019-05-20
Study Completion:2028-02-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03930953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
  2. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  1. * Life expectancy ≤ 2 months
  2. * Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
  3. * Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
  4. * Impaired cardiac function or clinically significant cardiac disease

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 109
Scottsdale, Arizona, 85259
United States
Local Institution - 111
Jacksonville, Florida, 32224
United States
Local Institution - 102
Tampa, Florida, 32207
United States
Local Institution - 108
Overland Park, Kansas, 66210
United States
Local Institution - 107
Rochester, Minnesota, 55905
United States
Local Institution - 104
Saint Louis, Missouri, 63110
United States
Local Institution - 103
Hackensack, New Jersey, 07601
United States
Local Institution - 101
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-20
Study Completion Date2028-02-09

Study Record Updates

Study Start Date2019-05-20
Study Completion Date2028-02-09

Terms related to this study

Keywords Provided by Researchers

  • Non-Hodgkin Lymphomas (NHL)
  • Safety
  • Efficacy
  • CC-99282
  • Rituximab
  • Relapsed
  • Refractory
  • Pharmacokinetics
  • Obinutuzumab
  • Tafasitamab
  • Valemetostat
  • Anti-lymphoma agents

Additional Relevant MeSH Terms

  • Lymphoma, Non-Hodgkin