Recurrent Adult Hodgkin's Lymphoma, Refractory Hodgkin Lymphoma
Conditions
Keywords
Refractory Hodgkin lymphoma, Relapsed Hodgkin Lymphoma
Brief summary
A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.
Interventions
DRUGINCB040093 Monotherapy
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
DRUGINCB040093
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
DRUGitacitinib
The dose of itacitinib will be given orally once daily (QD).
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women, aged 18 years or older * Histologically confirmed diagnosis of classical HL * Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens * Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin * Eastern Cooperative Oncology Group (ECOG) 0 to 2
Exclusion criteria
* Laboratory parameters not within the protocol-defined range * Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug. * Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent). * Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy * Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug * History of lymphoma involving the central nervous system * Evidence of active or prior hepatitis infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR) | Measured every 9 weeks from baseline until progression (estimated to be 12 months) | Evaluate the efficacy of INCB040093 as monotherapy and when given in combination with itacitinib by assessing the objective response rate (ORR) determined by an independent review committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting adverse events in the monotherapy group | every 3 weeks for the duration of participation in the study [estimated to be 12 months] | Safety and tolerability of INCB040093 as monotherapy in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events |
| Percentage of participants reporting adverse events in the combination therapy group | every 3 weeks for the duration of participation in the study [estimated to be 12 months] | Safety and tolerability of INCB040093 when given in combination with itacitinib in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events |
| Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria | Week 36 disease evaluation | Complete Response is determined by the independent review committee and based on standard response criteria defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. |
| To evaluate the duration of response (DOR) | Week 36 disease evaluation | Duration of response is defined as the time from the first assessment showing response (CR or PR) determined by the independent review committee to the first documented disease progression determined by the independent review committee or death due to any cause, whichever occurs first. |
| To evaluate the progression-free survival (PFS) | Week 36 disease evaluation | PFS was defined as the time from first dose to the first documented disease progression or relapse as assessed by independent review committee or death from any cause. |
Outcome results
None listed