Trial Outcomes & Findings for TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial (NCT NCT03043105)
NCT ID: NCT03043105
Last Updated: 2020-04-16
Results Overview
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.
UNKNOWN
PHASE2
25 participants
From baseline to the time point when a patient achieves treatment response for 24 weeks.
2020-04-16
Participant Flow
Participant milestones
| Measure |
TCP Treatment Group
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Baseline characteristics by cohort
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
n=5 Participants
|
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Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
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25 Participants
n=5 Participants
|
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Region of Enrollment
China
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25 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Number of Patients With Durable Tumor and Symptomatic Response
|
12 Participants
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SECONDARY outcome
Timeframe: 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 monthsProgression-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.
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Progression-free Survival
|
23.32 months
Interval 17.22 to 29.42
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Overall Survival
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32.16 months
Interval 28.08 to 36.24
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SECONDARY outcome
Timeframe: From baseline to 24 weeks after treatment.Population: 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.
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.
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Change in SF-36 Score
role emotional
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19.6 score on a scale
Standard Deviation 10.18
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|
Change in SF-36 Score
physical functioning
|
15.1 score on a scale
Standard Deviation 6.78
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|
Change in SF-36 Score
role physical
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26.7 score on a scale
Standard Deviation 10.53
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|
Change in SF-36 Score
vitality
|
11.1 score on a scale
Standard Deviation 5.75
|
|
Change in SF-36 Score
mental health
|
8.5 score on a scale
Standard Deviation 5.50
|
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Change in SF-36 Score
social functioning
|
13.6 score on a scale
Standard Deviation 6.70
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Change in SF-36 Score
bodily pain
|
15.8 score on a scale
Standard Deviation 6.19
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Change in SF-36 Score
general health
|
9.1 score on a scale
Standard Deviation 4.78
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SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)
|
10 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
TCP Treatment Group
n=25 Participants
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade)
|
2 Participants
|
Adverse Events
TCP Treatment Group
Serious adverse events
| Measure |
TCP Treatment Group
n=25 participants at risk
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Pulmonary infection
|
4.0%
1/25 • Number of events 1 • Safety data were collected until 30 days after the last dose of study drugs, except for secondary primary malignancies (which were assessed throughout the duration of follow-up, up to 4 years). Secondary primary malignancies were assessed throughout the duration of follow-up, up to 3 years.
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Skin and subcutaneous tissue disorders
Skin rash
|
4.0%
1/25 • Number of events 1 • Safety data were collected until 30 days after the last dose of study drugs, except for secondary primary malignancies (which were assessed throughout the duration of follow-up, up to 4 years). Secondary primary malignancies were assessed throughout the duration of follow-up, up to 3 years.
|
Other adverse events
| Measure |
TCP Treatment Group
n=25 participants at risk
The newly-diagnosed symptomatic MCD patients received thalidomide, cyclophosphamide and prednisone (TCP ) treatment. The accurate dose of TCP regimen is listed as follows.
* Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
* Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
* Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year.
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|---|---|
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Gastrointestinal disorders
constipation
|
40.0%
10/25 • Number of events 10 • Safety data were collected until 30 days after the last dose of study drugs, except for secondary primary malignancies (which were assessed throughout the duration of follow-up, up to 4 years). Secondary primary malignancies were assessed throughout the duration of follow-up, up to 3 years.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place