Phase 1
N=79
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Bottom Line
View on ClinicalTrials.gov: NCT00073749 ↗Enrolled (actual)
79
Serious AEs
32.9%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 29; 49; 11; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Inotuzumab ozogamicin [CMC-544] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
29; 49; 11; 15 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity |
24; 42 | — |
| PRIMARY Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts) |
1.8 | — |
| PRIMARY Number of Participants With Dose-limiting Toxicity (DLT) |
0; 0; 2; 1; 2; 0 | — |
| SECONDARY Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) |
103; 311 | — |
| SECONDARY Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts) |
49.5; 254 | — |
| SECONDARY Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts) |
274; NA | — |
| SECONDARY Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts) |
194; 1147 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts) |
1; 2; 3; 0; 8; 5 | — |
| SECONDARY Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts) |
80.00; 233.0 | — |
| SECONDARY Time-to-Tumor Progression: Part 2 (Expanded Cohorts) |
105; 339 | — |
Summary
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
Eligibility Criteria
Inclusion Criteria
- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
- At the expanded cohort, part 2 of the study, subjects must have one of the following:
- Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
- Diffuse large B-cell lymphoma
- Age 18 years or older
Exclusion Criteria
- Candidate for potentially curative therapies in the opinion of the investigator
- Chronic lymphocytic leukemia
- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
Data sourced from ClinicalTrials.gov (NCT00073749). 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.