NCT00562965 is a Phase 3 clinical trial of inotuzumab ozogamicin in Lymphoma, Follicular, sponsored by Pfizer.

Who is sponsoring NCT00562965?

NCT00562965 is sponsored by Pfizer.

What drugs are being tested in NCT00562965?

Interventions in NCT00562965: inotuzumab ozogamicin, rituximab, rituximab, cyclophosphamide, vincristine, prednisone/prednisolone, mitoxantrone, fludarabine, dexamethasone.

What condition does NCT00562965 study?

NCT00562965 studies Lymphoma, Follicular.

Is NCT00562965 still recruiting?

NCT00562965 is currently terminated. Last updated 8 December 2017.

Are results published for NCT00562965?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-12-08 · How we verify

NCT00562965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgkin's Lymphoma

Terminated Phase 3 Results posted Last updated 8 December 2017

What this trial tests

Phase 3 trial testing inotuzumab ozogamicin in Lymphoma, Follicular in 29 participants. Terminated before completion.

Timeline

1 November 2007

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	29
Start date	1 November 2007
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	39 locations across United States, Argentina, Belgium, Canada, Hong Kong, India, Italy, Mexico

Drugs / interventions tested

inotuzumab ozogamicin — full drug profile →
rituximab
rituximab
cyclophosphamide (cyclophosphamide) — full drug profile →
vincristine
prednisone/prednisolone
mitoxantrone (MITOXANTRONE) — full drug profile →
fludarabine (FLUDARABINE) — full drug profile →
dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Lymphoma, Follicular — all drugs for Lymphoma, Follicular →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Follicular. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression-Free Survival (PFS)
Time frame: Baseline until disease progression or death or up to 1 year after last dose of study drug
PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44.

Sponsor's own description

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2010.
Reichert JM. · · 2010 · cited 68× · PMID 20065640 · DOI 10.4161/mabs.2.1.10677
Advances in the treatment of hematologic malignancies using immunoconjugates.
Palanca-Wessels MC, Press OW. · · 2014 · cited 36× · PMID 24578502 · DOI 10.1182/blood-2013-10-492223
Novel antibody-based proteins for cancer immunotherapy.
Fuenmayor J, Montaño RF. · · 2011 · cited 5× · PMID 24212958 · DOI 10.3390/cancers3033370

Verify or expand the search:

Other trials of inotuzumab ozogamicin

Trials testing the same drug.

NCT05687032 — A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia · Phase 4 · completed
NCT01925131 — S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemi · Phase 1 · completed
NCT01564784 — A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Ac · Phase 3 · completed
NCT00299494 — Study Evaluating Inotuzumab Ozogamicin [CMC-544] Administered In Combination With Rituximab In Subjects With Non-Hodgkin · Phase 1, PHASE2 · completed

Other recruiting trials for Lymphoma, Follicular

Currently open trials in the same condition.

NCT06608147 — MOLyF : Bone Marrow and Follicular Lymphoma · NA · recruiting
NCT06425302 — A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diag · Phase 2 · active not recruiting
NCT06213636 — Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL). · Phase 1, PHASE2 · recruiting
NCT05410418 — Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma · Phase 2 · active not recruiting
NCT05228158 — A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00562965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 8 December 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00562965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing