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

NCT02471911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-04-12

No results posted yet for this study

Summary

This study evaluates the addition of selinexor (KPT-330) to RICE chemotherapy in the treatment of relapsed and refractory aggressive B-Cell Lymphoma, with the goal of improved response rates (as compared to RICE chemotherapy alone).

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

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • FDA Office of Orphan Products Development

    collaborator FED

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Peter Martin, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2019-10-31
Completion
2021-10-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471911 on ClinicalTrials.gov