Trial · NCT00587457
A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia
NCT00587457, Phase 1, Terminated, MedImmune LLC; results first posted 2017-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia. Trials, record NCT00587457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00587457
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia
- NCT number
- NCT00587457
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Leukemia, Lymphoma, Chronic Lymphocytic, Leukemia, Prolymphocytic Leukemia, Small, Lymphocytic Lymphoma, Moxetumomab Pasudotox
- Interventions
- CAT-8015 5 mcg/kg, CAT-8015 10 mcg/kg, CAT-8015 20 mcg/kg
- First posted
- 2008-01-07
- Last updated
- 2017-07-06
- Results first posted
- 2017-04-12
- Limitations and caveats
- The study was terminated early due to unavailability of investigational product.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration until 30 days after the last dose of study drug | An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox. Treatment-emergent were events between administration of investigational product and Day 28 that were absent before treatment or that worsened relative to pretreatment state. |
| Primary | Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration until 30 days after the last dose of study drug | The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. |
| Primary | Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration until 30 days after the last dose of study drug | AEs observed in participants with clinically significant ECG abnormalities were assessed. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration until 30 days after the last dose of study drug | An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes. |
| Primary | Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR) | Up to 2 years of post-treatment follow-up | Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria. |
| Primary | Best Overall Objective Tumor Response | Up to 2 years of post-treatment follow-up | Antitumor activity was assessed by best overall objective tumor response. |
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox | Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 | The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox. |
| Primary | Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox | Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 | The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox. |
| Secondary | Number of Participants With Positive Neutralizing Antibodies | Up to end of treatment (4-6 weeks after the last dose) | Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (\>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method. |
| Secondary | Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression | End of treatment (4-6 weeks after the last dose) | Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration until 30 days after the last dose of study drug | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration until 30 days after the last dose of study drug | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs) | From start of study drug administration until 30 days after the last dose of study drug | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration until 30 days after the last dose of study drug | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR) | Up to 2 years of post-treatment follow-up | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Best Overall Objective Tumor Response | Up to 2 years of post-treatment follow-up | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox | Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 | Safety population included all participants who received any treatment of moxetumomab pasudotox. Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. | hour | MEDIAN |
| PRIMARY | Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox | Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3 | Safety population included all participants who received any treatment of moxetumomab pasudotox. Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. | nanogram per milliliter | MEDIAN |
| SECONDARY | Number of Participants With Positive Neutralizing Antibodies | Up to end of treatment (4-6 weeks after the last dose) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression | End of treatment (4-6 weeks after the last dose) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group171
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | TEAEs | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | TESAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | TESAEs | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | TESAEs | 3 | Participants | |
| Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | Pyrexia | 1 | 0.56 | Participants |
| Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | Pyrexia | 0 | 0.70 | Participants |
| Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Pyrexia | 1 | 0.29 | Participants |
| Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | Sinus tachycardia | 1 | Participants |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 3 | |
| Overall Study | STARTED | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 3 | |
| Overall Study | STARTED | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 5 | |
| Overall Study | COMPLETED | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 0 | |
| Overall Study | COMPLETED | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 0 | |
| Overall Study | COMPLETED | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 0 | |
| Overall Study | NOT COMPLETED | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 3 | |
| Overall Study | NOT COMPLETED | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 3 | |
| Overall Study | NOT COMPLETED | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 5 |
Source ClinicalTrials.gov
Adverse events240
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 | Neutropenia | Blood and lymphatic system disorders | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 1 | 3 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 0 | 3 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 0 | 5 | 0 |
| other | Sinus tachycardia | Cardiac disorders | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 1 | 3 | 1 |
| other | Sinus tachycardia | Cardiac disorders | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 0 | 3 | 0 |
| other | Sinus tachycardia | Cardiac disorders | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 0 | 5 | 0 |
| other | Hypothyroidism | Endocrine disorders | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 0 | 3 | 0 |
| other | Hypothyroidism | Endocrine disorders | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 1 | 3 | 1 |
| other | Hypothyroidism | Endocrine disorders | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 0 | 5 | 0 |
| other | Vision blurred | Eye disorders | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 0 | 3 | 0 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | ||
| Total, all-cause mortality | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | ||
| Total, all-cause mortality | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | ||
| Total, other adverse events | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 3 | 3 |
| Total, other adverse events | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 3 | 3 |
| Total, other adverse events | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 5 | 5 |
| Total, serious adverse events | CAT-8015 5 Microgram Per Kilogram (mcg/kg) | 1 | 3 |
| Total, serious adverse events | CAT-8015 10 Microgram Per Kilogram (mcg/kg) | 2 | 3 |
| Total, serious adverse events | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | 3 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00587457
GET https://conductscience.org/api/trials/v1/NCT00587457/results?page=2