Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma

Part of paid clinical trials in Terre Haute, Indiana.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00633594
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1 Same for DL-1.
  • Bortezomib — DRUG
    DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11 Same for DL-1.
  • Lenalidomide — DRUG
    DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest

Study Details

This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).

Key Dates

Start date
Jun 30, 2008
Status verified
Dec 2016
Primary completion
Apr 30, 2015
Completion
Nov 30, 2016

Study Design

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

Arms

  • Experimental: rituximab/bortezomib/lenalidomide
    Patients in Phase I \& II to receive treatment with rituximab, bortezomib and lenalidomide in 21-day cycles up to 6 cycles. Phase I: Cohorts of 3 patients will be enrolled at escalating dose levels to determine the maximum tolerated dose (MTD). Doses may be de-escalated if necessary. Phase II: patients will be treated with the MTD determined in Phase I.

Primary Outcome Measure

Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants [ Time Frame: Collected from day of first dose to the end of the first treatment cycle, up to 21 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
Providence Medical GroupTerre HauteIndiana47802-
RHHP/ Hope Cancer CenterTerre HauteIndiana47802-
St. Louis Cancer CareChesterfieldMissouri63017-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology Care Inc.CincinnatiOhio45242-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Terre Haute, IN

By research site
Providence Medical Group· Terre Haute, INRHHP/ Hope Cancer Center· Terre Haute, INSt. Louis Cancer Care· Chesterfield, MOHematology-Oncology Associates of Northern NJ· Morristown, NJOncology Hematology Care Inc.· Cincinnati, OHChattanooga Oncology Hematology Associates· Chattanooga, TN

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