CC-99282-NHL-001
Research type
Research Study
Full title
A PHASE I, 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)
IRAS ID
304807
Contact name
Andrew Davies
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2018-003235-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 10 days
Research summary
Non-Hodgkin lymphoma is a heterogeneous group of diseases comprising diverse B-cell and T-cell lymphoma subtypes
Patients undergo a sequence of treatments and eventually the cells become resistant to available medications. There is an urgent need to develop new treatments in NHL as a majority of patients die due to their illness.
This clinical trial will evaluate a new medication developed to combat NHL. This medication has been developed with both information of how the available NHL drugs works, and how cells become resistant to current medications. This medication demonstrates ability to kill NHL cells in disease models tested in the laboratory. The activity of this medicine is sufficiently convincing from these experiments to explore the activity of these drugs in relapsed NHL patients.
This trial is conducted to determine the dose that can be safely tolerated using several different dosing schedules in the treatment of NHL patients. Patients who have NHL and have had a number of previous treatments, and now require further therapy will be eligible for this study. The medication is given in tablet form either alone or in combination with other medications with different schedules.
Occasionally patients will have to stay overnight to enable us to take blood samples. Blood samples will be taken to understand the levels of drugs in the body, effects of drug on NHL as well as rest of the bone marrow. This study will be conducted in hospitals experienced in dealing with NHL patients, as well as performing trials where new drugs are tested in NHL patients.
The study will be open for enrolment between one and 2 years in each of these trial centres. Once a patient signs up for the study on average they could expect to stay on the trial treatment for a period of up to 24 months. During this period standard assessments in the form of CT imaging, blood, urine and bone marrow tests will be taken. Patients will be observed for side effects and appropriate treatments will be given to address them. If the drug does demonstrate good response in a patient, they will be allowed to continue on these tablets until the drug ceases to be effective up to a maximum of 2 years. If the drug is not tolerated by a patient or their NHL continues to grow despite this treatment, they will come off this trial.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0873
Date of REC Opinion
17 Mar 2022
REC opinion
Further Information Favourable Opinion