Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation

PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 22, 2017

Primary Completion Date

February 11, 2022

Study Completion Date

February 11, 2022

Conditions
Hematopoietic/Lymphoid CancerRichter's Transformation
Interventions
DRUG

Blinatumomab

"Patients will receive blinatumomab as a continuous IV infusion, commencing on day 15 of cycle 1 and day 1 of cycle 2, for 2 courses of 4 weeks each separated by a 2 week .~blinatumomab will be initiated at 9mcg/day from day 15-21, followed by 28 mcg/day from day 22-28. This will be followed by 112 mcg/day from day 29-42. In cycle 2, patients will be admitted for the first 3 days.blinatumomab treatment-free interval."

DRUG

Dexamethasone

Dexamethasone 20 mg by mouth or vein 24 hours prior to and within 1 hour before start of treatment in each treatment cycle. If treatment is interrupted for \>4 hours at any point, Dexamethasone treatment given before re-initiation of therapy. Dexamethasone 8 mg by mouth or vein every 8 hours given for 48 hours at the commencement of the infusion and after each dose increment.

DRUG

Ibrutinib

Ibrutinib treatment will commence on cycle 1, day 1 at 420mg/d. Dose reductions to 280mg/d or 140mg/d are allowed per treating physician discretion, but the reason must be documented in the medical record. Ibrutinib will be given continuously until disease progression or toxicity.

DRUG

Nivolumab

Patients will receive nivolumab for up to a total of 52 weeks. Dosing will be 240mg IV every 2 weeks, commencing on day 1 until 2nd response assessment, then 480mg IV every 4 weeks.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT03121534 - Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation | Biotech Hunter | Biotech Hunter