A Study of Enasidenib in People With T-Cell Lymphoma
ConditionT-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The researchers are doing this study to find out whether enasidenib is a safe treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The researchers will look at the safety of enasidenib when it is given alone or in combination with the drug rituximab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years at time of consent
Has freely given written informed consent to participate in the study
Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR). For R/R patients, disease must have relapsed or progressed after at least one systemic therapy, diagnostic tumor samples have at least 5% tumor.
Age ≥18 years at time of enrollment
Disqualifiers
Performance status, as assessed in the ECOG grading system, ≤2
Laboratory criteria (use of GCSF and/or blood product transfusions to reach eligibility criteria must be discussed with the MSK PI on a case-by-case basis): i) Absolute neutrophil count ≥1.0 K/μL or ≥0.5 K/μL if due to lymphoma ii) Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma iii) Calculated creatinine clearance ≥30 mL/min by the Modification of Diet in Renal Disease (MDRD) glomerular filtration rate iv) Total bilirubin ≤1.5x upper limit of normal (ULN) or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; AST and ALT ≤ 3x ULN; ≤ 5x ULN if due to lymphoma involvement
Revised International Working Group Classification for systemic lymphoma(13)
Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
Trial design
Design model
Single group
Treatments tested in this trial
Enasidenib
DrugEnasidenib 100 mg daily on 28-day cycles.
Rituximab
DrugIV rituximab 375 mg/m² weekly for the first month, and monthly thereafter on 28-day cycles, for a total of four months of rituximab.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Enasidenib and rituximabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
response rate
a 20% response rate is undesirable and 45% is desirable
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Bristol-Myers Squibb
Collaborator
The Leukemia and Lymphoma Society
Collaborator
Source ClinicalTrials.gov