Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT02446236
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Dose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21
  • Ibrutinib — DRUG
    560 mg PO daily
  • Rituximab — DRUG
    375 mg/m2 IV Day 1

Study Details

This is a dose-escalation to determine the MTD and/or RPII for combinations of ibrutinib (PCI-32765) plus lenalidomide/rituximab in patients with relapsed/refractory mantle cell lymphoma.

Key Dates

Start date
Jun 18, 2015
Status verified
Mar 2026
Primary completion
Jan 3, 2017
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Dose Escalation Study
    Ibrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21

Primary Outcome Measure

Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events [ Time Frame: 28 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

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The Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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