Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin's Lymphoma (NHL)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT00299494
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • inotuzumab ozogamicin — DRUG
    IV, 1.8 mg/m2, q4w
  • inotuzumab ozogamicin — DRUG
    IV, 1.8 mg/m2, q4w
  • inotuzumab ozogamicin — DRUG
    IV, 1.8 mg/m2, q4w
  • Rituximab — DRUG
    rituximab 375 mg/m\^2 via IV infusion on Day 1

Study Details

The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Key Dates

Start date
May 4, 2006
Status verified
Feb 2018
Primary completion
May 19, 2014
Completion
Jun 2, 2014

Study Design

Enrollment
119 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (FOLLICULAR)
    Follicular
  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (DLBCL)
    Diffuse Large B-cell Lymphoma
  • Experimental: INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB (REFRACTORY)
    Refractory Aggressive NHL

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 ) [ Time Frame: First 28-day cycle ]

Locations (19)

FacilityCityStateZIPSite coordinators
IDS PharmacyBirminghamAlabama35249-
University of Alabama at Birmingham-BirminghamAlabama35249 - 3300-
University of Alabama at Birmingham-BirminghamAlabama35294-
California Cancer Care, Inc.GreenbraeCalifornia94904-
University of California Medical CenterSan FranciscoCalifornia94143-
California Cancer CareSan MateoCalifornia94402-
Emory ClinicAtlantaGeorgia30322-
Emory University HospitalAtlantaGeorgia30322-
Emory University Investigational Drug ServiceAtlantaGeorgia30322-
Northwestern Medical Faculty FoundationChicagoIllinois60611-
Nevada Cancer Institute-Las VegasNevada89135-
Rosewell Park Cancer InstituteBuffaloNew York14263-
Gabrail Cancer CenterCantonOhio44718-
Cleveland ClinicClevelandOhio44195-
University Hospitals of ClevelandClevelandOhio44106-
Gabrail Cancer CenterDoverOhio44622-
UHHS - WestlakeWestlakeOhio44145-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Birmingham, AL

By research site
IDS Pharmacy· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, ALCalifornia Cancer Care, Inc.· Greenbrae, CAUniversity of California Medical Center· San Francisco, CACalifornia Cancer Care· San Mateo, CAEmory Clinic· Atlanta, GA

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