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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT02471911
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KPT-330 — DRUG
    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.
  • Rituximab — DRUG
    IV Rituximab 375 mg/m2 on D1
  • Etoposide — DRUG
    IV Etoposide 100 mg/m2 on D1-3
  • Carboplatin — DRUG
    IV Carboplatin AUC 5 on D2
  • Ifosfamide — DRUG
    IV Ifosfamide 5 g/m2 on D2
  • Dexamethasone — DRUG
    20 mg qd on Days -5 and -3. 20 mg qd on Days 1-5

Study Details

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).

Key Dates

Start date
Dec 11, 2015
Status verified
Apr 2022
Primary completion
Oct 31, 2019
Completion
Oct 14, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All subjects
    All subjects will receive KPT-330 (selinexor) on days -5 and -3 starting one week before RICE chemotherapy is started. Once chemotherapy starts, selinexor will be given on days 1, 3, and 5 of each chemotherapy cycle. RICE chemotherapy will consist of Rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone.

Primary Outcome Measure

Maximum Tolerated Dosage (MTD) of Selinexor/KPT-330 when combined with RICE chemo in a relapsed/refractory aggressive b-cell lymphoma setting. [ Time Frame: approximately 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10021-

Find similar trials in New York, NY

By research site
Weill Cornell Medical College· New York, NY

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