Trial · NCT00586924
A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
NCT00586924, Phase 1, Completed, MedImmune LLC; results first posted 2019-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia. Trials, record NCT00586924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00586924
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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 in Patients With Hairy Cell Leukemia
- NCT number
- NCT00586924
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 49 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Hairy Cell Leukemia
- Interventions
Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), Moxetumomab Pasudotox (CAT 8015), CAT 8015 (Moxetumomab Pasudotox), Moxetumomab Pasudotox (CAT 8015)
- First posted
- 2008-01-07
- Last updated
- 2019-04-02
- Results first posted
- 2019-04-02
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days) | Adverse events are suspected of causal relationship to drug and are \>=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any \>= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following \>= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting \<2 months, G 3 hypoalbuminemia lasting \<7 days occurred in absence of CLS. |
| 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 (approximately 8 years) | The TEAEs are defined as adverse events (AEs) 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. |
| 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 (approximately 8 years) | Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension. |
| 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 (approximately 8 years) | Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree. |
| 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 (approximately 8 years) | 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. |
| Primary | Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks. |
| Primary | Number of Participants With Complete Response (CR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | The CR is defined by: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as exhibited by: Neutrophils \>= 1,500/microliter (mcL), Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gram per deciliter (gm/dL) without transfusions or growth factors for at least 4 weeks. |
| Primary | Number of Participants With Partial Response (PR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Partial response requires all of the following: \>=50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, \>=50% reduction in lymphadenopathy, \>=50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam, Neutrophils \>= 1,500/mcL or 50% improvement over baseline without growth factors for at least 4 weeks, Platelets \>=100,000/mcL or 50% improvement over baseline, and Hemoglobin \>= 11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. For participants who are transfusion-dependent at baseline, a hemoglobin of \>= 9.0 g/dL without transfusions or growth factors for at least 4 weeks. |
| Primary | Number of Participants With Stable Disease (SD) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Stable disease was characterized by not meeting the criteria for CR, PR or PD. |
| Primary | Number of Participants With Progressive Disease (PD) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Progressive disease is defined by at least one of the following compared to pretreatment:\>= 25% increase in the sum of the products of the greatest perpendicular dimensions of at least two lymph nodes on two consecutive examinations at least 2 weeks apart (at least 1 node must be \>= 2 cm) or appearance of new palpable lymph nodes, \>=25% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, or appearance of new palpable hepatomegaly or splenomegaly that was not previously present, \>=50% increase in the absolute number of circulating lymphocytes, \>=25% decrease in hemoglobin (must be \< 11g/dL), platelets (must be \< 100,000/mcL), or absolute neutrophil count (must be \< 1500/mcL) unless these are judged to be effects of treatment. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
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 Dose Limiting Toxicities (DLTs) | Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days) | Evaluable population for DLT included all participants who received any treatment of moxetumomab pasudotox, completed at least Cycle 2 Day 10, or discontinued treatment due to a DLT on or before Cycle 2 Day 10. | Participants | COUNT_OF_PARTICIPANTS |
| 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 (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| 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 (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| 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 (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| 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 (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Complete Response (CR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Partial Response (PR) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Stable Disease (SD) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Progressive Disease (PD) | From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years) | Safety population included all participants who received any treatment of moxetumomab pasudotox. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group455
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 Dose Limiting Toxicities (DLTs) | 5 mcg/kg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | 10 mcg/kg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | 20 mcg/kg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | 30 mcg/kg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | 40 mcg/kg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | 50 mcg/kg | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 5 mcg/kg | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 10 mcg/kg | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 20 mcg/kg | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 30 mcg/kg | TEAEs | 3 | Participants |
1 to 10 of 455Source ClinicalTrials.gov
See all 455 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5 mcg/kg | 3 | |
| Overall Study | STARTED | 10 mcg/kg | 3 | |
| Overall Study | STARTED | 20 mcg/kg | 3 | |
| Overall Study | STARTED | 30 mcg/kg | 3 | |
| Overall Study | STARTED | 40 mcg/kg | 4 | |
| Overall Study | STARTED | 50 mcg/kg | 33 | |
| Overall Study | COMPLETED | 5 mcg/kg | 0 | |
| Overall Study | COMPLETED | 10 mcg/kg | 0 | |
| Overall Study | COMPLETED | 20 mcg/kg | 0 | |
| Overall Study | COMPLETED | 30 mcg/kg | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events510
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 | Febrile neutropenia | Blood and lymphatic system disorders | 5 mcg/kg | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 10 mcg/kg | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 20 mcg/kg | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 30 mcg/kg | 0 | 3 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 40 mcg/kg | 0 | 4 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | 50 mcg/kg | 2 | 33 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | 5 mcg/kg | 2 | 3 | 4 |
| other | Lymphopenia | Blood and lymphatic system disorders | 10 mcg/kg | 0 | 3 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | 20 mcg/kg | 2 | 3 | 3 |
| other | Lymphopenia | Blood and lymphatic system disorders | 30 mcg/kg | 0 | 3 | 0 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5 mcg/kg | ||
| Total, all-cause mortality | 10 mcg/kg | ||
| Total, all-cause mortality | 20 mcg/kg | ||
| Total, all-cause mortality | 30 mcg/kg | ||
| Total, all-cause mortality | 40 mcg/kg | ||
| Total, all-cause mortality | 50 mcg/kg | ||
| Total, other adverse events | 5 mcg/kg | 3 | 3 |
| Total, other adverse events | 10 mcg/kg | 3 | 3 |
| Total, other adverse events | 20 mcg/kg | 3 | 3 |
| Total, other adverse events | 30 mcg/kg | 3 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00586924
GET https://conductscience.org/api/trials/v1/NCT00586924/registered?page=2