NCT00299494 is a Phase 1, PHASE2 clinical trial of inotuzumab ozogamicin in B-Cell Lymphoma, sponsored by Pfizer.

Who is sponsoring NCT00299494?

NCT00299494 is sponsored by Pfizer.

What drugs are being tested in NCT00299494?

Interventions in NCT00299494: inotuzumab ozogamicin, inotuzumab ozogamicin, inotuzumab ozogamicin, Rituximab.

What condition does NCT00299494 study?

NCT00299494 studies B-Cell Lymphoma.

Is NCT00299494 still recruiting?

NCT00299494 is currently completed. Last updated 8 March 2018.

Are results published for NCT00299494?

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

Last reviewed 2018-03-08 · How we verify

NCT00299494

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

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

Completed Phase 1, PHASE2 Results posted Last updated 8 March 2018

What this trial tests

Phase 1, PHASE2 trial testing inotuzumab ozogamicin in B-Cell Lymphoma in 119 participants. Completed in 2 June 2014.

Timeline

4 May 2006

Primary endpoint
19 May 2014

2 June 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	119
Start date	4 May 2006
Primary completion	19 May 2014
Estimated completion	2 June 2014
Sites	38 locations across France, Hong Kong, Italy, Netherlands, Belgium, United Kingdom, Germany, Poland

Drugs / interventions tested

inotuzumab ozogamicin — full drug profile →
inotuzumab ozogamicin — full drug profile →
inotuzumab ozogamicin — full drug profile →
Rituximab — full drug profile →

Conditions studied

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

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with B-Cell Lymphoma. 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.

Maximum Tolerated Dose (MTD) of Inotuzumab Ozogamicin in Combination With Rituximab (375 mg/m^2 ) Primary · First 28-day cycle

Inotuzumab ozogamicin was dose escalated (3 to 6 evaluable participants enrolled per dose cohort) during the first 28 days after the first administration of inotuzumab ozogamicin + rituximab. Enrollment at the next dose level or enrollment of additional subjects into a cohort proceeded according to the following criteria: 0 dose-limiting toxicity (DLT) by Day 28 of first dose move to higher dose, 1 participant reporting DLT but no others in cohort by Day 28 of first dose move to higher dose, greater than 2 participants reporting DLT by Day 28 of first dose stop and prior dose level considered

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN + RITUXIMAB 375 MG/M^2	1.8

Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) Primary · Protocol reporting period of from informed consent to at least 28 days after the last dose. This outcome measure time frame: From the first dose of study drug to up to 56 days after the last dose of either study drug.

A TEAE is any event that occurred after the first dose of study drug up to 56 days post the last dose of study drug (either rituximab or inotuzumab ozogamicin).

% participants with a TEAE

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	100
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	100
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	100
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	100
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	100
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	100

% participants with serious TEAE

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	20.0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	14.3
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	26.5
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	30.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	16.7

% participants with Grade 3 or 4 TEAE

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	80.0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	66.7
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	71.4
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	67.6
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	75.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	63.3

% participants with Grade 5 TEAE

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	20.0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	2.5
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	6.7

% participants for study drug discontinuation

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	33.3
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	28.6
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	61.8
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	50.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	33.3

% participants with dose reduction due to TEAE

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	14.3
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	14.7
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	10.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	0

% participants for study drug stopped temporarily

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	20.0
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	0
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	42.9
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	44.1
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	40.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	10.0

Percentage of Participants With Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR) Secondary · Approximately every 2 (during treatment) or 3 (during follow-up) to 6 months for up to 5 years from 1st dose

CR: a. Complete disappearance of all detectable clinical and radiographic evidence of disease, disease-related symptoms, and normalization of NHL assignable biochemical abnormalities ; b. lymph nodes and nodal masses must have regressed to normal size; c. Spleen regressed in size and not palpable on physical exam, size of other organs enlarged due to disease decreased in size; d. Repeat bone marrow infiltrate clear. CRu: CR but allows for a. Residual lymph node mass \>1.5 cm in greatest transverse diameter has regressed by more than 75% in diameter. Individual nodes that were previously conflu

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	40	5.3 – 85.3
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	100	29.2 – 100
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	57.1	18.4 – 90.1
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	94.1	80.3 – 99.3
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	72.5	56.1 – 85.4
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	20	7.7 – 38.6

Kaplan-Meier Estimates of Progression Free Survival (PFS) Secondary · From the date of first dose of test article until the first date on which disease progression or death was documented or new anticancer start, any of which could be reported up to 5 years post last dose

The Kaplan-Meier method was used to determine PFS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \>= 50% in the size of previously involved sites, c. \>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \>= 50% increase from nadir in the product diameter of any previously identified abnormal node for PRs or nonresponders, e. Enlarging spl

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	1.7	0.3 – NA
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	21.2 – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	1.7 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	NA	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	17.1	6.8 – 56.6
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	1.8	1.0 – 3.9

Kaplan-Meier Estimates of the Probability of Being Progression Free at 6 Months Secondary · From the first dose to 6 months after first dose

Progression Free Survival is defined as the time interval from the first dose of test article until the first date on which relapsed disease, progression, initiation of new anti-cancer treatment due to persistent/refractory disease, or death was documented, censored at the last tumor evaluation.

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2	0.4	0.1 – 0.8
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	1.0	NA – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0.6	0.2 – 0.8
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	1.0	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	0.7	0.5 – 0.8
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	0.2	0.1 – 0.4

Kaplan-Meier Estimates of Overall Survival (OS) Secondary · From the first dose up to 5 years post last dose

OS was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	7.4	0.5 – NA
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	21.7 – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	16.9	5.3 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	NA	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	58.3	34.8 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	8.4	3.7 – 40.4

Kaplan-Meier Estimates of the Probability of Survival at 6 Months Secondary · From the first dose to 6 months after first dose.

Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact. The Kaplan-Meier method was used to determine OS. 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0.6	0.1 – 0.9
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	1.0	NA – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0.7	0.3 – 0.9
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	1.0	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	0.9	0.8 – 1.0
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	0.6	0.4 – 0.7

Kaplan-Meier Estimates of Time to Tumor Progression (TTP) Secondary · From the date of first dose of test article until the first date on which disease progression or death was documented, any of which could be reported up to 5 years post last dose.

TTP is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \>= 50% in the size of previously involved sites, c. \>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \>= 50% increase from nadir in the product diameter of any previo

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	1.7	0.3 – NA
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	21.2 – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	1.7 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	NA	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	45.1	15.2 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	1.7	1.0 – 5.1

Kaplan-Meier Estimates of the Probability of Being Event Free at 6 Months Secondary · From enrollment to up to 6 months from 1st dose.

Time-to-Tumor Progression (TTP): is defined as the interval from the first dose of the test article until the first date on which relapsed disease or progression, or death secondary to progression is documented, censored at the last disease assessment. Relapsed or Progressive Disease (PD) requires the following: a. Appearance of any new lesions, b. Increase by \>=50% in the size of previously involved sites, c. \>= 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node, d. \>= 50% increase from nadir in the pr

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0.4	0.1 – 0.8
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	1.0	NA – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	0.7	0.3 – 0.9
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	1.0	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	0.7	0.5 – 0.9
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	0.3	0.1 – 0.4

Duration of Response (CR+CRu+PR) Secondary · Time from date measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the first date relapsed disease or date of death (whichever occurs first) is objectively documented.

Time from date measurement criteria met for CR, CRu, or PR (whichever occurred first) until first date relapsed disease/date of death. CR: Complete disappearance of all detectable clinical, radiographic evidence of disease, disease-related symptoms, normalization of NHL assignable biochemical abnormalities; lymph nodes, nodal masses regressed to normal size; spleen size regressed, not palpable on physical exam, size of other organs enlarged due to disease. CRu: CR but allows for: residual lymph node mass \>1.5 cm in greatest transverse diameter that regressed \>75% in product diameter. Individ

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN 0.8 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	14.4 – NA
INOTUZUMAB OZOGAMICIN 1.3 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	17.7 – NA
INOTUZUMAB OZOGAMICIN 1.8 MG/M^2 + RITUXIMAB 375 MG/M^2	NA	3.0 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (FOLLICULAR)	NA	NA – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (DLBCL)	43.2	16.4 – NA
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2 (REFRACTORY)	3.9	2.3 – NA

Area Under the Serum Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 30 and Day 58 Secondary · Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85

Serum concentration of inotuzumab ozogamicin on Dosing Days 30 and 58 were measured. AUCinf of inotuzumab ozogamicin was reported. AUCinf: AUClast (area under the serum concentration-time profile for inotuzumab ozogamicin from time zero to the time of the last quantifiable concentration) +(Clast \[last quantifiable concentration\]/kel \[elimination rate constant\]) where Clast is the predicted serum concentration of inotuzumab ozogamicin at the last quantifiable timepoint estimated from the log-linear regression analysis. Study Days Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57

Dosing Day 30

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2	36030	± 34

Dosing Day 58

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2	40550	± 28

AUClast of Inotuzumab Ozogamicin in Participants Receiving Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 on Dosing Day 1, Day 30 and Day 58 Secondary · Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85

Serum concentration of inotuzumab ozogamicin on Dosing Days 1, 30 and 58 were measured. AUC of inotuzumab ozogamicin was reported. AUClast is area under the serum concentration-time profile from time zero to the time of the Clast, using Linear/Log trapezoidal method. Study Days Cycle 1, Days 1 (0 hour), 2 (0, 1, 4 hours), 4, 8, 10, 15, and 29; Cycle 2, Days 30 (0, 1, 4 hours), 32, 36, 38, 43, 50, and 57; and Cycle 3, Days 58 (0, 1, 4 hours), 60, 64, 66, 71, 78, and 85 correspond to Dosing Day 1 for Cycle 1; Dosing Day 30 for Cycle 2; and Dosing Day 58 for Cycle 3.

Dosing Day 1

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2	6157	± 190

Dosing Day 30

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2	9664	± 76191

Dosing Day 58

Group	Value	95% CI
INOTUZUMAB OZOGAMICIN MTD + RITUXIMAB 375 MG/M^2	17320	± 225

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded and reported from the time a participant signed the Informed Consent Form (ICF) until at least 28 days after last dose of study treatment. Summarized data reflects incidents from 1st dose to up to 56 days post last dose.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Inotuzumab Ozogamicin 0.8 mg/m^2+ Rituximab 375 mg/m^2

Serious: 1/5 (20%)

Deaths: —

Inotuzumab Ozogamicin 1.3 mg/m^2+ Rituximab 375 mg/m^2

Serious: 0/3 (0%)

Deaths: —

Inotuzumab Ozogamicin 1.8 mg/m^2+ Rituximab 375 mg/m^2

Serious: 1/7 (14%)

Deaths: —

Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Follicular

Serious: 9/34 (26%)

Deaths: —

Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 DLBCL

Serious: 12/40 (30%)

Deaths: —

Inotuzumab Ozogamicin MTD + Rituximab 375 mg/m^2 Refractory

Serious: 5/30 (17%)

Deaths: —

Serious adverse events (54 terms)

Reaction	System	Inotuzumab Ozogamicin 0.8 …	Inotuzumab Ozogamicin 1.3 …	Inotuzumab Ozogamicin 1.8 …	Inotuzumab Ozogamicin MTD …	Inotuzumab Ozogamicin MTD …	Inotuzumab Ozogamicin MTD …
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Haemorrhage	Vascular disorders	—	—	—	—	—	—
Shock	Vascular disorders	—	—	—	—	—	—
Barrett's oesophagus	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Duodenal ulcer	Gastrointestinal disorders	—	—	—	—	—	—
Duodenitis	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal perforation	Gastrointestinal disorders	—	—	—	—	—	—
Intestinal ischaemia	Gastrointestinal disorders	—	—	—	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—
Visceroptosis	Gastrointestinal disorders	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—

Other adverse events (156 terms — click to expand)

Reaction	System	Inotuzumab Ozogamicin 0.8 …	Inotuzumab Ozogamicin 1.3 …	Inotuzumab Ozogamicin 1.8 …	Inotuzumab Ozogamicin MTD …	Inotuzumab Ozogamicin MTD …	Inotuzumab Ozogamicin MTD …
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Memory impairment	Nervous system disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—

Most-reported serious reactions: Nausea, Vomiting, Dizziness, Neutropenia, Thrombocytopenia, Neck pain, Pain in extremity, Cancer pain.

Data from ClinicalTrials.gov NCT00299494 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab.
Fayad L, Offner F, Smith MR, Verhoef G, et al · · 2013 · cited 120× · PMID 23295790 · DOI 10.1200/jco.2012.42.7211
Advances in targeted therapy for malignant lymphoma.
Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
Antibody-drug conjugates in clinical trials for lymphoid malignancies and multiple myeloma.
Yu B, Liu D. · · 2019 · cited 70× · PMID 31500657 · DOI 10.1186/s13045-019-0786-6
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
Antibody-drug conjugates for the treatment of lymphoma: clinical advances and latest progress.
Chu Y, Zhou X, Wang X. · · 2021 · cited 48× · PMID 34090506 · DOI 10.1186/s13045-021-01097-z
The promising role of antibody drug conjugate in cancer therapy: Combining targeting ability with cytotoxicity effectively.
Li WQ, Guo HF, Li LY, Zhang YF, et al · · 2021 · cited 36× · PMID 34165267 · DOI 10.1002/cam4.4052
Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806
Antibody-drug conjugates for lymphoma patients: preclinical and clinical evidences.
Barreca M, Lang N, Tarantelli C, Spriano F, et al · · 2022 · cited 23× · PMID 36654819 · DOI 10.37349/etat.2022.00112

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

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Currently open trials in the same condition.

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NCT05757700 — Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Lymphoma · Phase 1 · active not recruiting
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NCT05281809 — Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia · Phase 2 · recruiting

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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 NCT00299494 (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 March 2018

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/NCT00299494.

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NCT00299494

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (54 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of inotuzumab ozogamicin

Other recruiting trials for B-Cell Lymphoma

Other Pfizer trials

Verify against primary sources