Trial · NCT02222688
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT02222688, Phase 1, Completed, Thomas Kipps; results first posted 2020-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia. Trials, record NCT02222688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02222688
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
- NCT number
- NCT02222688
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Thomas Kipps
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- cirmtuzumab
- First posted
- 2014-08-21
- Last updated
- 2020-08-13
- Results first posted
- 2020-08-13
- Limitations and caveats
Some patients enrolled in extension study (#NCT02860676)\& cut-off date for AE observation may be date patient was first treated on extension, therefor AE Timeframe period difficult to reconcile. 0 deaths observed during study observation period.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) or Biologically Active Dose of Cirmtuzumab | 1 year | The MTD is defined as the highest dose studied at which no more than one in six patients experience a dose-limiting toxicity (DLT) during the DLT observation period. The biologically active dose will be determined at a dose below or equal to the MTD upon review of the the study data; the final determination will also consider any cumulative or delayed toxicity. |
| Primary | Rate of Dose Limiting Toxicities (DLTs) | The DLT observation period is 56 days from the start of the first infusion for the intra-patient dosing cohorts and 28 days after the start of the first infusion for subsequent dosing cohorts | The occurrence of any of the following adverse events considered to be possibly, probably, or definitely related to cirmtuzumab within the DLT observation period (56 days from the first infusion for cohorts with intrapatient dose escalation, and 28 days of the start investigational treatment for cohorts without intrapatient dose escalation): 1. Grade 3 or greater non-hematologic toxicity with the exception of Grade 3 infusion reaction. 2. Grade 4 neutropenia lasting more than 5 days despite appropriate medical management. 3. Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion. 4. Grade 3 or greater febrile neutropenia (temperature ≥ 38.5ºC). 5. Grade 4 anemia unexplained by underlying disease. 6. Any AE requiring a dose delay of greater than 14 days. 7. Patients with baseline cytopenias or starting blood counts in the grade 2 range are evaluable for hematologic DLT. |
| Secondary | Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs. | From the start of investigational treatment to completion of follow-up, an average of 33 weeks | Treatment emergent adverse events (description, timing, CTCAE grade, severity, seriousness, and relatedness) |
| Secondary | Clinical Activity Determined by the International Working Group in CLL (iwCLL) Criteria | From baseline visit to response assessment visit at 56 days after final cirmtuzumab infusion, an average of 52 days | Clinical response \[stable disease (SD) or progressive disease (PD)\] defined by iwCLL criteria including clinical, hematological, and bone marrow features for a period of at least 2 months from completion of therapy |
| Secondary | Progression Free Survival as Determined by iwCLL Criteria | From start of treatment until objective tumor progression or death | The duration of time from the start of study treatment until objective tumor progression or death |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) or Biologically Active Dose of Cirmtuzumab | 1 year | mg/kg | NUMBER | |
| PRIMARY | Rate of Dose Limiting Toxicities (DLTs) | The DLT observation period is 56 days from the start of the first infusion for the intra-patient dosing cohorts and 28 days after the start of the first infusion for subsequent dosing cohorts | Occurrence of DLTs | NUMBER | |
| SECONDARY | Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs. | From the start of investigational treatment to completion of follow-up, an average of 33 weeks | Treatment emergent AEs | NUMBER | |
| SECONDARY | Clinical Activity Determined by the International Working Group in CLL (iwCLL) Criteria | From baseline visit to response assessment visit at 56 days after final cirmtuzumab infusion, an average of 52 days | Evaluable subjects or those who completed 4 cycles of cirmtuzumab | participants | NUMBER |
| SECONDARY | Progression Free Survival as Determined by iwCLL Criteria | From start of treatment until objective tumor progression or death | Weeks | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) or Biologically Active Dose of Cirmtuzumab | All Participants | 20 | mg/kg | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 0.015 - 0.03 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 0.5 - 1.0 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 2.0 - 4.0 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 8 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 16 mg/kg | 0 | Occurrence of DLTs | ||
| Rate of Dose Limiting Toxicities (DLTs) | Cirmtuzumab 20 mg/kg | 0 | Occurrence of DLTs | ||
| Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs. | Cirmtuzumab 0.015 - 0.03 mg/kg | 20 | Treatment emergent AEs | ||
| Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs. | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 37 | Treatment emergent AEs |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cirmtuzumab 0.015 - 0.03 mg/kg | 4 | |
| Overall Study | STARTED | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 3 | |
| Overall Study | STARTED | Cirmtuzumab 0.5 - 1.0 mg/kg | 3 | |
| Overall Study | STARTED | Cimrtuzumab 2.0 - 4.0 mg/kg | 5 | |
| Overall Study | STARTED | Cirmtuzumab 8 mg/kg | 3 | |
| Overall Study | STARTED | Cirmtuzumab 16 mg/kg | 3 | |
| Overall Study | STARTED | Cirmtuzumab 20 mg/kg | 6 | |
| Overall Study | COMPLETED | Cirmtuzumab 0.015 - 0.03 mg/kg | 3 | |
| Overall Study | COMPLETED | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 3 | |
| Overall Study | COMPLETED | Cirmtuzumab 0.5 - 1.0 mg/kg | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events595
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 0.015 - 0.03 mg/kg | 4 | 4 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 3 | 3 | 12 |
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 0.5 - 1.0 mg/kg | 3 | 3 | 9 |
| other | Anemia | Blood and lymphatic system disorders | Cimrtuzumab 2.0 - 4.0 mg/kg | 3 | 5 | 9 |
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 8 mg/kg | 3 | 3 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 16 mg/kg | 3 | 3 | 14 |
| other | Anemia | Blood and lymphatic system disorders | Cirmtuzumab 20 mg/kg | 4 | 6 | 10 |
| other | Atrial fibrillation | Cardiac disorders | Cirmtuzumab 0.015 - 0.03 mg/kg | 0 | 4 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 0 | 3 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Cirmtuzumab 0.5 - 1.0 mg/kg | 0 | 3 | 0 |
1 to 10 of 595Source ClinicalTrials.gov
See all 595 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cirmtuzumab 0.015 - 0.03 mg/kg | 0 | 4 |
| Total, all-cause mortality | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 0 | 3 |
| Total, all-cause mortality | Cirmtuzumab 0.5 - 1.0 mg/kg | 0 | 3 |
| Total, all-cause mortality | Cimrtuzumab 2.0 - 4.0 mg/kg | 0 | 5 |
| Total, all-cause mortality | Cirmtuzumab 8 mg/kg | 0 | 3 |
| Total, all-cause mortality | Cirmtuzumab 16 mg/kg | 0 | 3 |
| Total, all-cause mortality | Cirmtuzumab 20 mg/kg | 0 | 6 |
| Total, other adverse events | Cirmtuzumab 0.015 - 0.03 mg/kg | 4 | 4 |
| Total, other adverse events | Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | 3 | 3 |
| Total, other adverse events | Cirmtuzumab 0.5 - 1.0 mg/kg | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29859176 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02222688
GET https://conductscience.org/api/trials/v1/NCT02222688/results?page=2