NCT00724971 is a Phase 1 clinical trial of Inotuzumab Ozogamicin (CMC-544) in Lymphoma, B-Cell, sponsored by Pfizer.

Who is sponsoring NCT00724971?

NCT00724971 is sponsored by Pfizer.

What drugs are being tested in NCT00724971?

Interventions in NCT00724971: Inotuzumab Ozogamicin (CMC-544), Rituximab (Rituxan).

What condition does NCT00724971 study?

NCT00724971 studies Lymphoma, B-Cell.

Is NCT00724971 still recruiting?

NCT00724971 is currently completed. Last updated 15 March 2019.

Are results published for NCT00724971?

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

Last reviewed 2019-03-15 · How we verify

NCT00724971

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

Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

Completed Phase 1 Results posted Last updated 15 March 2019

What this trial tests

Phase 1 trial testing Inotuzumab Ozogamicin (CMC-544) in Lymphoma, B-Cell in 10 participants. Completed in 10 March 2010.

Timeline

4 July 2008

Primary endpoint
10 March 2010

10 March 2010

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	4 July 2008
Primary completion	10 March 2010
Estimated completion	10 March 2010
Sites	4 locations across Japan

Drugs / interventions tested

Inotuzumab Ozogamicin (CMC-544) — full drug profile →
Rituximab (Rituxan)

Conditions studied

Lymphoma, B-Cell — all drugs for Lymphoma, B-Cell →

Sponsor

Pfizer — full company profile →

Who can join

Adults 20 to 75, any sex, with Lymphoma, B-Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose-limiting Toxicities (DLT) Primary · Up to 28 days

A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting \>=7 days, 4) Grade 4 thrombocytopenia lasting \>=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade \<=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose \>2 weeks

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	2

Number of Participants With Objective Response: Evaluable Population Secondary · Up to 8 cycles (1 cycle = 28 days)

Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or \>75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or \>=50% decrease in the SPD.

Complete response (CR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	6

Complete response unconfirmed (CRu)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	1

Partial response (PR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0

Objective Response (CR+CRu+PR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	7

Number of Participants With Objective Response: Intent-to-treat (ITT) Population Secondary · Up to 8 cycles (1 cycle = 28 days)

Complete response (CR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	6

Complete response unconfirmed (CRu)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	1

Partial response (PR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	1

Objective Response (CR+CRu+PR)

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	8

Progression-Free Survival (PFS) Secondary · Up to 591 days

The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by \>=50% in the size.

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	NA	NA – NA

Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544) Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies.

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	559	± 136

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	822	± 152

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	958	± 64.0

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	67.7	± 14.9

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	80.2	± 11.3

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	96.6	± 2.89

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	839	± 157

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	1110	± 88.9

Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544 Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

The time measured for the serum concentration to decrease by one half.

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	18.77	± 1.09

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	29.08	± 21.79

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	51.70	± 20.59

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	61.23	± 34.84

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	96.44	± 31.31

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	167.87	± 72.85

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	67.14	± 31.84

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	101.59	± 34.08

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544 Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

AUClast= Area under the serum concentration versus time curve from time zero (pre-dose) to time of last measured concentration.

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	12300	± 6200

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	27000	± 7450

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	50100	± 6390

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	2850	± 1400

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	6490	± 2250

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	10700	± 4750

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	38400	± 16300

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	84900	± 23400

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544 Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

AUC∞ = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	22300	± 2850

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	34800	± 12200

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	54800	± 7070

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	4060	± 1100

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	7460	± 2540

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	12700	± 5400

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	47700	± 14300

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	92300	± 26300

Clearance (CL) of CMC-544, Total Calicheamicin, and G544 Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

The rate at which a drug is metabolized or eliminated by normal biological processes.

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.120	± 0.0185

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.0782	± 0.0192

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.0499	± 0.0012

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.746	± 0.212

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.424	± 0.133

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.249	± 0.0686

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.0662	± 0.0236

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0.0331	± 0.0077

Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544 Secondary · Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544

The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

CMC-544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	2.33	± 0.0763

CMC-544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	2.26	± 1.74

CMC-544: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	3.02	± 1.23

Total Calicheamicin: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	47.6	± 11.3

Total Calicheamicin: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	45.6	± 7.04

Total Calicheamicin: Cycle 3

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	47.8	± 6.62

G544: Cycle 1

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	3.95	± 0.921

G544: Cycle 2

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	3.39	± 0.515

Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544) Secondary · Up to 8 Cycles (1 cycle = 28 days)

Antibody responses to CMC-544

Screening

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	1

End of Treatment

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0

Number of Participants With Positive Serum Antibody to Rituximab Secondary · Up to 8 Cycles (1 cycle = 28 days)

Antibody responses to rituximab

Screening

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0

End of Treatment

Group	Value	95% CI
CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2	0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2

Serious: 0/10 (0%)

Deaths: —

Other adverse events (82 terms — click to expand)

Reaction	System	CMC-544 1.8 mg/m^2 + Ritux…
Thrombocytopenia	Blood and lymphatic system disorders	—
Aspartate aminotransferase increased	Investigations	—
Leukopenia	Blood and lymphatic system disorders	—
Nausea	Gastrointestinal disorders	—
Alanine aminotransferase increased	Investigations	—
Neutropenia	Blood and lymphatic system disorders	—
Lymphopenia	Blood and lymphatic system disorders	—
Blood lactate dehydrogenase increased	Investigations	—
Fatigue	General disorders	—
Blood alkaline phosphatase increased	Investigations	—
Decreased appetite	Metabolism and nutrition disorders	—
Hyperbilirubinaemia	Hepatobiliary disorders	—
Headache	Nervous system disorders	—
Stomatitis	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Nasopharyngitis	Infections and infestations	—
Gamma-glutamyltransferase increased	Investigations	—
Haemoglobin decreased	Investigations	—
Constipation	Gastrointestinal disorders	—
Chills	General disorders	—
Malaise	General disorders	—
Blood glucose increased	Investigations	—
C-reactive protein increased	Investigations	—
Hypophosphataemia	Metabolism and nutrition disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Anaemia	Blood and lymphatic system disorders	—
Erythropenia	Blood and lymphatic system disorders	—
Lymphocytosis	Blood and lymphatic system disorders	—
Monocytosis	Blood and lymphatic system disorders	—
Arrhythmia	Cardiac disorders	—
Palpitations	Cardiac disorders	—
Tinnitus	Ear and labyrinth disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Abdominal distension	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT00724971 adverse events section.

Sponsor's own description

To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

Publications & conference data

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

Inotuzumab: from preclinical development to success in B-cell acute lymphoblastic leukemia.
Wynne J, Wright D, Stock W. · · 2019 · cited 50× · PMID 30622147 · DOI 10.1182/bloodadvances.2018026211
Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma.
Ogura M, Hatake K, Ando K, Tobinai K, et al · · 2012 · cited 50× · PMID 22335424 · DOI 10.1111/j.1349-7006.2012.02241.x

Verify or expand the search:

Other trials of Inotuzumab Ozogamicin (CMC-544)

Trials testing the same drug.

NCT00868608 — Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma · Phase 2 · completed

Other recruiting trials for Lymphoma, B-Cell

Currently open trials in the same condition.

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Other Pfizer trials

Trials by the same sponsor.

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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 NCT00724971 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 15 March 2019

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/NCT00724971.

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

NCT00724971

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Inotuzumab Ozogamicin (CMC-544)

Other recruiting trials for Lymphoma, B-Cell

Other Pfizer trials

Verify against primary sources