Clinical trial · Interventional
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
NCT00073749CI-TRIAL-00036156completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab ozogamicin [CMC-544] | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inotuzumab ozogamicin
- description
- Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
- interventionNames
- Drug: Inotuzumab ozogamicin [CMC-544]
Primary outcomes (4)
- measure
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to 42 days after last dose of study drug (up to Day 225)
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.