Trial · NCT03805932
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
NCT03805932, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia. Trials, record NCT03805932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03805932
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
- NCT number
- NCT03805932
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hairy Cell Leukemia
- Interventions
- Moxetumomab Pasudotox-tdfk, Rituximab, Ruxience, Dexamethasone, Acetaminophen, Diphenhydramine, Famotidine, Aspirin
- First posted
- 2019-01-16
- Last updated
- 2026-06-29
- Results first posted
- 2023-11-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Safe Dose of Moxetumomab Pasudotox-tdfk | 4 weeks | Recommended safe dose of moxetumomab pasudotox-tdfk is defined as the treatment of 10 participants with no more than 2 experiencing a dose-limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Primary | Recommended Safe Dose of Rituximab/Ruxience | 4 weeks | Recommended safe dose of rituximab/Ruxience is defined as the treatment of 10 participants with no more than 2 experiencing a dose-limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Secondary | Number of Participants Whose Cancer Shrinks or Disappears After Treatment | 28-42 days after day 1 of the last treatment. | Number of participants whose cancer shrinks or disappears after treatment defined as minimal residual disease. MRD is no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate. |
| Secondary | Number of Participants Who Are Minimal Residual Disease (MRD)-Free | 28-42 days after day 1 of the last treatment. | MRD-free is defined as participants with no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate. |
| Secondary | Duration of Response (DOR) | 28-42 days after day 1 of the last treatment. | DOR is defined as the time of initial response until documented tumor progression. Response was assessed by the and is defined as an increase in symptoms or \>25% decline in hematologic parameters related to disease, based on the judgement of the principal investigator. ≥50% increase in sum of products of perpendicular diameters of evaluable (\> 2cm) lymphadenopathy or appearance of new evaluable lymph nodes \> 2 cm short axis. |
| Other | Number of Participants With a Dose-limiting Toxicity (DLT) | From the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose | Dose limiting toxicity (DLT) is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Safe Dose of Moxetumomab Pasudotox-tdfk | 4 weeks | mcg/kg | NUMBER | |
| PRIMARY | Recommended Safe Dose of Rituximab/Ruxience | 4 weeks | mcg/kg | NUMBER | |
| SECONDARY | Number of Participants Whose Cancer Shrinks or Disappears After Treatment | 28-42 days after day 1 of the last treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Are Minimal Residual Disease (MRD)-Free | 28-42 days after day 1 of the last treatment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response (DOR) | 28-42 days after day 1 of the last treatment. | |||
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-limiting Toxicity (DLT) | From the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Safe Dose of Moxetumomab Pasudotox-tdfk | All Participants | 40 | mcg/kg | ||
| Recommended Safe Dose of Rituximab/Ruxience | All Participants | 40 | mcg/kg | ||
| Number of Participants Whose Cancer Shrinks or Disappears After Treatment | Moxetumomab - Dose Escalation 30 mcg/kg | 2 | Participants | ||
| Number of Participants Whose Cancer Shrinks or Disappears After Treatment | Moxetumomab - Dose Expansion 40 mcg/kg | 11 | Participants | ||
| Number of Participants Who Are Minimal Residual Disease (MRD)-Free | Moxetumomab - Dose Escalation 30 mcg/kg | 2 | Participants | ||
| Number of Participants Who Are Minimal Residual Disease (MRD)-Free | Moxetumomab - Dose Expansion 40 mcg/kg | 11 | Participants | ||
| Number of Participants With a Dose-limiting Toxicity (DLT) | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | Participants | ||
| Number of Participants With a Dose-limiting Toxicity (DLT) | Moxetumomab - Dose Expansion 40 mcg/kg | 0 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Moxetumomab - Dose Escalation 30 mcg/kg | 3 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Moxetumomab - Dose Expansion 40 mcg/kg | 15 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxetumomab - Dose Escalation 30 mcg/kg | 3 | |
| Overall Study | STARTED | Moxetumomab - Dose Expansion 40 mcg/kg | 15 | |
| Overall Study | COMPLETED | Moxetumomab - Dose Escalation 30 mcg/kg | 3 | |
| Overall Study | COMPLETED | Moxetumomab - Dose Expansion 40 mcg/kg | 15 | |
| Overall Study | NOT COMPLETED | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | |
| Overall Study | NOT COMPLETED | Moxetumomab - Dose Expansion 40 mcg/kg | 0 |
Source ClinicalTrials.gov
Adverse events204
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 | Abdominal distension | Gastrointestinal disorders | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Moxetumomab - Dose Expansion 40 mcg/kg | 1 | 15 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Moxetumomab - Dose Expansion 40 mcg/kg | 2 | 15 | 4 |
| other | Alanine aminotransferase increased | Investigations | Moxetumomab - Dose Escalation 30 mcg/kg | 1 | 3 | 5 |
| other | Alanine aminotransferase increased | Investigations | Moxetumomab - Dose Expansion 40 mcg/kg | 10 | 15 | 24 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Moxetumomab - Dose Escalation 30 mcg/kg | 1 | 3 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Moxetumomab - Dose Expansion 40 mcg/kg | 1 | 15 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | 3 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Moxetumomab - Dose Expansion 40 mcg/kg | 1 | 15 | 1 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxetumomab - Dose Escalation 30 mcg/kg | 1 | 3 |
| Total, all-cause mortality | Moxetumomab - Dose Expansion 40 mcg/kg | 0 | 15 |
| Total, other adverse events | Moxetumomab - Dose Escalation 30 mcg/kg | 3 | 3 |
| Total, other adverse events | Moxetumomab - Dose Expansion 40 mcg/kg | 15 | 15 |
| Total, serious adverse events | Moxetumomab - Dose Escalation 30 mcg/kg | 0 | 3 |
| Total, serious adverse events | Moxetumomab - Dose Expansion 40 mcg/kg | 2 | 15 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants Whose Cancer Shrinks or Disappears After Treatment | Trial comparisons |
| Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants With a Dose-limiting Toxicity (DLT) | Trial comparisons |
Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: deaths from any cause | Trial comparisons |
| Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: Number of Participants Who Are Minimal Residual Disease (MRD)-Free | Trial comparisons |
| Moxetumomab - Dose Escalation 30 mcg/kg vs Moxetumomab - Dose Expansion 40 mcg/kg: serious adverse events | Trial comparisons |
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/NCT03805932
GET https://conductscience.org/api/trials/v1/NCT03805932/events?page=2