Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Pfizer
Study ID
NCT00867087
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

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

Interventions

  • inotuzumab ozogamicin (CMC-544) — DRUG
    1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses
  • rituximab — DRUG
    375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Study Details

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Key Dates

First listed
Mar 23, 2009
Start date
Jun 8, 2009
Status verified
Oct 2017
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
64 participants (actual)
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2
    Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).

Primary Outcome Measure

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy [ Time Frame: Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period) ]

Locations (21)

FacilityCityStateZIPSite coordinators
Loyola University Medical Center, Foster G. McGraw Hospital and SatellitesMaywoodIllinois60153-
Tufts Medical CenterBostonMassachusetts02111-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Siteman Cancer CenterCity of Saint PetersMissouri63376-
Barnes-Jewish HospitalSt LouisMissouri63110-1094-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenteRHackensackNew Jersey07601-
John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)HackensackNew Jersey07601-1941-
John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)HackensackNew Jersey07601-2105-
John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)HackensackNew Jersey07601-
John Theurer Cancer Center, Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan - Kettering Cancer CenterNew YorkNew York10065-
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
UT Southwestern Medical CenterDallasTexas75390-
UT Southwestern University Hospital - St. PaulDallasTexas75235-
Zale Lipshy University HospitalDallasTexas75235-
The University of Texas, M. D. Anderson Cancer CenterHoustonTexas77030-4009-
University of Texas, MD Anderson Cancer CenterHoustonTexas77030-
Methodist Healthcare System ofSan AntonioTexas78229-
Pharmaceutical Research CenterMadisonWisconsin53792-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-0001-

Find similar trials in Maywood, IL

By research site
Loyola University Medical Center, Foster G. McGraw Hospital and Satellites· Maywood, ILTufts Medical Center· Boston, MAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MISiteman Cancer Center· City of Saint Peters, MOBarnes-Jewish Hospital· St Louis, MOWashington University School of Medicine· St Louis, MO

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