KPT-330 Plus RICE for Relapsed/Refractory Aggressive B-Cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 11, 2015

Primary Completion Date

October 31, 2019

Study Completion Date

October 14, 2021

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

KPT-330

KPT-330 administered orally on days -5 and -3 prior to starting chemotherapy. Once chemotherapy starts, KPT-330 will be administered on days 1, 3, and 5 of each cycle. Dose levels will range from 20 mg to 100mg with a standard 3+3 escalation schema.

DRUG

Rituximab

IV Rituximab 375 mg/m2 on D1

DRUG

Etoposide

IV Etoposide 100 mg/m2 on D1-3

DRUG

Carboplatin

IV Carboplatin AUC 5 on D2

DRUG

Ifosfamide

IV Ifosfamide 5 g/m2 on D2

DRUG

Dexamethasone

20 mg qd on Days -5 and -3. 20 mg qd on Days 1-5

Trial Locations (1)

10021

Weill Cornell Medical College, New York

Sponsors
All Listed Sponsors
collaborator

Karyopharm Therapeutics Inc

INDUSTRY

collaborator

The Leukemia and Lymphoma Society

OTHER

collaborator

FDA Office of Orphan Products Development

FED

lead

Weill Medical College of Cornell University

OTHER