ACTIVE_NOT_RECRUITING

A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

Talk to us

Conditions

Relapsed/Refractory B-cell Non-Hodgkin LymphomaLymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cellnon-Hodgkin lymphoma (NHL)Follicular lymphoma (FL)Marginal zone lymphoma (MZL)Mantle cell lymphoma (MCL)Burkitt lymphoma (BL)Primary central nervous system lymphoma (PCNSL)Diffuse large B-cell lymphoma (DLBCL)CAR T-cell therapyDiffuse large B-cell lymphoma - Richter Transformation (DLBCL-RT)small lymphocytic leukemia (SLL)chronic lymphocytic leukemia (CLL)

Quick Navigation

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

This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use. This study will be carried out in 2 phases: * The first phase is to see which doses of GLPG5101 work best with the least number of side effects. * In the second phase, participants will receive the selected dose(s) based on the results in the first phase.

Official Title

A Phase I/II, Multicenter Study Evaluating the Feasibility, Safety, and Efficacy of Point-of-care Manufactured GLPG5101 (19CP02) in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Quick Facts

Study Start:2022-03-09
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06561425

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. * Histologically confirmed diagnosis of one of the following NHL subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, MCL, BL, PCNSL, DLBCL-RT, High Grade B-cell Lymphoma (HGBL), CLL/SLL
  2. * Relapsed or refractory disease
  3. * Presence of at least one measurable lesion according to the Lugano classification (except for PCNSL subjects ineligible for ASCT after induction therapy, Cohort 6b; and except for CLL/SLL subjects without a measurable lesion or a PET positive lesion will be eligible if they have splenomegaly (spleen size \>13 cm) and bone marrow infiltration with lymphoma)
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Participants with ECOG 2 must have serum albumin ≥ 3.4 gram/deciliter)
  5. * Adequate bone marrow function
  6. * Adequate renal, hepatic and pulmonary function
  7. * Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of conditioning chemotherapy
  8. * Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception and agree to remain on a highly effective method of contraception from the time of signing the informed consent form until at least 12 months after GLPG5101 infusion. Subjects must agree to not donate eggs or sperm during this period.
  1. * Selected prior treatments as defined in the protocol
  2. * History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years. (exceptions per protocol)
  3. * Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
  4. * Active central nervous system (CNS) involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study (exceptions per protocol)
  5. * Clinically significant cardiac disease
  6. * Primary immunodeficiency
  7. * Stroke or seizure within 6 months of screening
  8. * History of autoimmune disease requiring systemic immunosuppression or disease modifying treatment within 28 days before screening
  9. * Infection with human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C virus
  10. * Systemic fungal, bacterial, viral, or other infection that is not controlled

Contacts and Locations

Principal Investigator

Galapagos Study Director
STUDY_DIRECTOR
Galapagos NV

Study Locations (Sites)

Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Galapagos NV

  • Galapagos Study Director, STUDY_DIRECTOR, Galapagos NV

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 Date2022-03-09
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2022-03-09
Study Completion Date2029-07-01

Terms related to this study

Keywords Provided by Researchers

  • non-Hodgkin lymphoma (NHL)
  • Follicular lymphoma (FL)
  • Marginal zone lymphoma (MZL)
  • Mantle cell lymphoma (MCL)
  • Burkitt lymphoma (BL)
  • Primary central nervous system lymphoma (PCNSL)
  • Diffuse large B-cell lymphoma (DLBCL)
  • CAR T-cell therapy
  • Diffuse large B-cell lymphoma - Richter Transformation (DLBCL-RT)
  • small lymphocytic leukemia (SLL)
  • chronic lymphocytic leukemia (CLL)

Additional Relevant MeSH Terms

  • Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
  • Lymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cell