Trial · NCT03043105
TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
NCT03043105, Phase 2, Unknown, Peking Union Medical College Hospital; results first posted 2020-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial. Trials, record NCT03043105. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03043105
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
- NCT number
- NCT03043105
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Peking Union Medical College Hospital
- Conditions
- Multicentric Castleman Disease
- Interventions
- Thalidomide, cyclophosphamide and prednisone
- First posted
- 2017-02-03
- Last updated
- 2020-04-16
- Results first posted
- 2020-04-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Durable Tumor and Symptomatic Response | From baseline to the time point when a patient achieves treatment response for 24 weeks. | Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months. |
| Secondary | Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained \>1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD. |
| Secondary | Overall Survival | From date of randomization until the date of death from any cause, assessed up to 36 months. | Overall survival, defined as the time to patients' death, is measured. |
| Secondary | Change in SF-36 Score | From baseline to 24 weeks after treatment. | SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks. |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade) | From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy. | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included) |
| Secondary | Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade) | From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy. | Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Durable Tumor and Symptomatic Response | From baseline to the time point when a patient achieves treatment response for 24 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | months | MEAN | |
| SECONDARY | Overall Survival | From date of randomization until the date of death from any cause, assessed up to 36 months. | months | MEAN | |
| SECONDARY | Change in SF-36 Score | From baseline to 24 weeks after treatment. | Each patient is assessed by SF-36 scoring system, which contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade) | From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade) | From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Durable Tumor and Symptomatic Response | TCP Treatment Group | 12 | Participants | ||
| Progression-free Survival | TCP Treatment Group | 23.32 | 95% Confidence Interval 17.22 to 29.42 | months | |
| Overall Survival | TCP Treatment Group | 32.16 | 95% Confidence Interval 28.08 to 36.24 | months | |
| Change in SF-36 Score | TCP Treatment Group | physical functioning | 15.1 | Standard Deviation 6.78 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | role physical | 26.7 | Standard Deviation 10.53 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | role emotional | 19.6 | Standard Deviation 10.18 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | vitality | 11.1 | Standard Deviation 5.75 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | mental health | 8.5 | Standard Deviation 5.50 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | social functioning | 13.6 | Standard Deviation 6.70 | score on a scale |
| Change in SF-36 Score | TCP Treatment Group | bodily pain | 15.8 | Standard Deviation 6.19 | score on a scale |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TCP Treatment Group | 25 | |
| Overall Study | COMPLETED | TCP Treatment Group | 25 | |
| Overall Study | NOT COMPLETED | TCP Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events3
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 | constipation | Gastrointestinal disorders | TCP Treatment Group | 10 | 25 | 10 |
| serious | Pulmonary infection | Respiratory, thoracic and mediastinal disorders | TCP Treatment Group | 1 | 25 | 1 |
| serious | Skin rash | Skin and subcutaneous tissue disorders | TCP Treatment Group | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TCP Treatment Group | 3 | 25 |
| Total, other adverse events | TCP Treatment Group | 10 | 25 |
| Total, serious adverse events | TCP Treatment Group | 2 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30760451 | DERIVED |
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/NCT03043105
GET https://conductscience.org/api/trials/v1/NCT03043105/registered