Trial · NCT04585893
Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi
NCT04585893, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2025-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi. Trials, record NCT04585893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04585893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Rituximab for Treatment of Multicentric Castleman Disease in Malawi
- NCT number
- NCT04585893
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Multicentric Castleman Disease
- Interventions
- Rituximab, Etoposide
- First posted
- 2020-10-14
- Last updated
- 2026-07-30
- Results first posted
- 2025-09-11
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) | From the start of rituximab-based therapy to 12 weeks. (Up to 13 weeks) | Safety was assessed by the number of participants with non-hematologic Grade ≥3 adverse events (AEs) and treatment-related mortality. AEs were evaluated using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE v5). CTCAE defines AE severity as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), and Grade 5 (death related to AE). |
| Secondary | Characterization of MCD Presentation in Malawi | Baseline - until 21 days | Characterization of Multicentric Castleman disease (MCD) presentation in Malawi will be summarized using baseline demographics and laboratory values. Descriptive statistics will be performed. |
| Secondary | Overall Survival | 90 days, 1 year, and 2 years | Overall survival is the measure of time from the first treatment day to the date of death for any cause. Subjects who have not had an event will be censored at the date of the last assessment documenting the subject was alive. |
| Secondary | Event-free Survival | 90 days, 1 year, and 2 years | Event-free survival is the measure of time after treatment during which no sign of cancer (refractory disease, relapse, non-Hodgkin lymphoma development, or death ) is found. |
| Secondary | Efficacy of Risk-adjusted Treatment | At the end of the treatment, 12 weeks after start of the treatment | The efficacy of risk-adjusted treatment will be defined as the clinical response rate which is the resolution of presenting signs/symptoms that defined the Multicentric Castleman disease (MCD) attack. MCD attack/flare is defined as the presence of each of the following three criteria: 1) Fever (subjective or objective), 2) Lymphadenopathy or hepatosplenomegaly, 3) At least one of the following signs or symptoms attributable to MCD by the local study investigator: a) Weight loss \>5%, b) Malaise, c) Anemia (Hemoglobin \<10 g/dL), and d) Thrombocytopenia (Platelets \<100 x 10\^3/uL). |
| Secondary | Clinical Response Rate | At the end of the treatment, 12 weeks after start of the treatment | Clinical Response Rate will be defined as the percentage of subjects who achieved resolution of presenting signs/symptoms that defined the Multicentric Castleman disease (MCD) attack) without relapse. |
| Secondary | Radiological Response Rate | At the end of the treatment, 12 weeks after start of the treatment | The Radiological Response Rate will be defined as the percentage of subjects without relapse defined using chest radiography, abdominal sonography, and physical exam for gross lymphadenopathy. Response criteria for lymph node response will be Complete response (CR)- the disappearance of all evident disease; Partial response (PR)-at least a 50% decrease in target lesions with no increase in non-target lesions, Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD); PD- the appearance of a new lesion or at least a 50% increase in lesion size. |
| Secondary | Additional Safety | First day of the treatment through 12 weeks (Up to 13 weeks) | Additional Safety will be defined as all Adverse Events occurred. AEs will be evaluated using National Cancer Institute's Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). |
| Secondary | The Rate of Kaposi Sarcoma Exacerbation | Up to 2 years | The rate of Kaposi sarcoma exacerbation will be determined by symptomatic or clinical (dermatologic or visceral organ) exacerbation of the disease. All disease flares will be biopsy confirmed whenever possible. |
| Secondary | Quality of Life- Patient-reported Outcomes Questionnaires | Baseline, week3, end of the treatment, 12 weeks, 6 months after the treatment, 24 months after the treatment, time of relapse. | Quality of Life- patient-reported outcomes (PRO) questionnaires will be assessed by the Patient-Reported Outcomes Measurement Information System Global Health Survey (PROMIS Global-10). The survey includes 10 items about mental and physical health rated on Likert scales ranging from 1 to 5, with higher scores indicative of better health. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) | From the start of rituximab-based therapy to 12 weeks. (Up to 13 weeks) | All participants started the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Characterization of MCD Presentation in Malawi | Baseline - until 21 days | |||
| SECONDARY | Overall Survival | 90 days, 1 year, and 2 years | |||
| SECONDARY | Event-free Survival | 90 days, 1 year, and 2 years | |||
| SECONDARY | Efficacy of Risk-adjusted Treatment | At the end of the treatment, 12 weeks after start of the treatment | |||
| SECONDARY | Clinical Response Rate | At the end of the treatment, 12 weeks after start of the treatment | |||
| SECONDARY | Radiological Response Rate | At the end of the treatment, 12 weeks after start of the treatment | |||
| SECONDARY | Additional Safety | First day of the treatment through 12 weeks (Up to 13 weeks) | |||
| SECONDARY | The Rate of Kaposi Sarcoma Exacerbation | Up to 2 years | |||
| SECONDARY | Quality of Life- Patient-reported Outcomes Questionnaires | Baseline, week3, end of the treatment, 12 weeks, 6 months after the treatment, 24 months after the treatment, time of relapse. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) | High-risk Patients | 0 | Participants | ||
| Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) | Low-risk Patients | 0 | 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 | High-risk Patients | 9 | |
| Overall Study | STARTED | Low-risk Patients | 6 | |
| Overall Study | COMPLETED | High-risk Patients | 8 | |
| Overall Study | COMPLETED | Low-risk Patients | 6 | |
| Overall Study | NOT COMPLETED | High-risk Patients | 1 | |
| Overall Study | NOT COMPLETED | Low-risk Patients | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | High-risk Patients | 8 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Low-risk Patients | 5 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | High-risk Patients | 2 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Low-risk Patients | 0 | 6 | |
| other | Flu like symptoms | General disorders | High-risk Patients | 0 | 9 | |
| other | Flu like symptoms | General disorders | Low-risk Patients | 1 | 6 | |
| other | Non-cardiac chest pain | General disorders | High-risk Patients | 2 | 9 | |
| other | Non-cardiac chest pain | General disorders | Low-risk Patients | 0 | 6 | |
| other | Lung infection | Infections and infestations | High-risk Patients | 4 | 9 | |
| other | Lung infection | Infections and infestations | Low-risk Patients | 0 | 6 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High-risk Patients | 1 | 9 |
| Total, all-cause mortality | Low-risk Patients | 0 | 6 |
| Total, other adverse events | High-risk Patients | 9 | 9 |
| Total, other adverse events | Low-risk Patients | 6 | 6 |
| Total, serious adverse events | High-risk Patients | 1 | 9 |
| Total, serious adverse events | Low-risk Patients | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K01TW011470 | Safety, efficacy, and cost-effectiveness of rituximab for multicentric Castleman disease in Malawi | PAINSCHAB, MATTHEW SCOTT | UNIV OF NORTH CAROLINA CHAPEL HILL | FOGARTY INTERNATIONAL CENTER | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High-risk Patients vs Low-risk Patients: Number of Participant With Non-hematologic Grade ≥3 Adverse Events (AEs) | Trial comparisons |
| High-risk Patients vs Low-risk Patients: deaths from any cause | Trial comparisons |
| High-risk Patients vs Low-risk Patients: 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/NCT04585893
GET https://conductscience.org/api/trials/v1/NCT04585893/events?page=2