Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically diagnosed follicular lymphoma grade 1-3a
Have no prior systemic treatment for lymphoma
Stage II, III or IV disease
Age ≥18 years
Disqualifiers
Known active central nervous system lymphoma or leptomeningeal disease
Adequately treated localized skin cancer without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk
Trial design
Design model
Single group
Treatments tested in this trial
Obinutuzumab
DrugGiven by IV (vein)
CC-99282
DrugGiven by PO
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: Obinutuzumab+CC-99282Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov