18 and older, any sex, with 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.
Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHLPrimary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to \[≤\]1.5 cm in their greatest transverse diameter \[GTD\] for nodes more than \[\>\]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as \>50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
66.7
55.32 – 76.76
Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes \>1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as \>50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
70.8
58.93 – 80.95
Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes \>1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
30.9
21.07 – 42.11
Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes \>1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
34.7
23.88 – 46.86
Duration of Response in Participants With Indolent NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New le
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
24.8
10.9 – NA
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHLSecondary· 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50%
6 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
0.82
0.68 – 0.90
12 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
0.65
0.50 – 0.77
24 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
0.53
0.38 – 0.66
Duration of Response in Participants With Follicular NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50%
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
24.8
12.9 – NA
Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHLSecondary· 6, 12 and 24 months
Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not 'Not Done' or 'Unknown'. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50%
6 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
0.85
0.71 – 0.92
12 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
0.67
0.51 – 0.79
24 Month Probability of Maintaining a Response
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
0.57
0.40 – 0.70
Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) \>1.5 cm (any axis); ≥50% increase in SPD of \>1 node; or ≥50% increase in lo
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
12.7
8.9 – 26.9
Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHLSecondary· 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) \>1.5 cm (any axis); ≥50% increase in SPD of \>1 node; or ≥50% increase in lo
6 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
65.1
53.3 – 74.6
12 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
52.0
40.0 – 62.7
24 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - Total (All NHL Types)
41.3
29.8 – 52.5
Kaplan-Meier Estimate of the PFS in Participants With Follicular NHLSecondary· Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) \>1.5
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
14.7
11.0 – NA
Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHLSecondary· 6, 12 and 24 months
Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) \>1.5
6 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
69.3
56.8 – 78.8
12 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
56.3
43.4 – 67.3
24 Months
Group
Value
95% CI
Inotuzumab Ozogamicin - NHL Type (Follicular)
46.1
33.5 – 57.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Collected from time of informed consent up to a minimum of 28 days after last dose of study drug. Adverse event (AE) summaries below are inclusive of AEs from first dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Inotuzumab Ozogamicin - NHL Type (Follicular)
Serious: 12/72 (17%)
Deaths: —
Inotuzumab Ozogamicin - NHL Type (Marginal Zone)
Serious: 2/4 (50%)
Deaths: —
Inotuzumab Ozogamicin - NHL Type (Small Lymphocytic)
Serious: 1/5 (20%)
Deaths: —
Serious adverse events (27 terms)
Reaction
System
Inotuzumab Ozogamicin - NH…
Inotuzumab Ozogamicin - NH…
Inotuzumab Ozogamicin - NH…
Pyrexia
General disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
—
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00724971 — Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
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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: 31 October 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/NCT00868608.