Phase 2
N=81
Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00868608 ↗Enrolled (actual)
81
Serious AEs
18.5%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL — 66.7 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Inotuzumab Ozogamicin (CMC-544) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL |
66.7 | — |
| SECONDARY Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL |
70.8 | — |
| SECONDARY Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL |
30.9 | — |
| SECONDARY Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL |
34.7 | — |
| SECONDARY Duration of Response in Participants With Indolent NHL |
24.8 | — |
| SECONDARY Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL |
0.82; 0.65; 0.53 | — |
| SECONDARY Duration of Response in Participants With Follicular NHL |
24.8 | — |
| SECONDARY Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL |
0.85; 0.67; 0.57 | — |
| SECONDARY Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL |
12.7 | — |
| SECONDARY 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 NHL |
65.1; 52.0; 41.3 | — |
| SECONDARY Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL |
14.7 | — |
| SECONDARY 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 NHL |
69.3; 56.3; 46.1 | — |
| SECONDARY Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL |
NA | — |
| SECONDARY Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL |
0.89; 0.80; 0.73 | — |
| SECONDARY Kaplan-Meier Estimate of the OS in Participants With Follicular NHL |
NA | — |
| SECONDARY Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL |
0.91; 0.83; 0.78 | — |
| SECONDARY Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax) |
3.51; 5.00; 6.41; 7.83 | — |
| SECONDARY Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) |
96.3; 18.5; 77.8; 58.0; 33.3; 48.1 | — |
| SECONDARY Percentage of Participants With QTc Interval Corrected Using Fridericia's Formula (QTcF) by Category (Safety Population) |
83.1; 14.3; 2.6; 0; 98.7; 79.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
- Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
- Measurable disease with adequate bone marrow function, renal and hepatic function
Exclusion Criteria
- History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
- Prior allogeneic hematopoietic stem cell transplant (HSCT).
- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
Data sourced from ClinicalTrials.gov (NCT00868608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.