Trial · NCT07535710
Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma
NCT07535710, Phase 1, Phase 2, Not yet recruiting, Shanghai Jiao Tong University School of Medicine
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma. Trials, record NCT07535710. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07535710
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma
- NCT number
- NCT07535710
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Conditions
- Cutaneous T-Cell Lymphoma Refractory, Cutaneous T-Cell Lymphoma, Relapsed, Sezary Syndrome, Cutaneous T Cell Lymphoma (CTCL)
- Interventions
- Aclarubicin, Cyclophosphamide, Vincristine, Prednisone
- First posted
- 2026-04-17
- Last updated
- 2026-04-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | 28 days after first dose of aclarubicin | MTD for aclarubicin (primary outcome measure of phase I) |
| Primary | Recommended Phase 2 Dose (RP2D) | 28 days after first dose of aclarubicin | RP2D for aclarubicin (primary outcome measure of phase I) |
| Primary | Objective response rate (ORR) | At the end of induction cycle 6 (each cycle is about 28 days) | Proportion of patients who achieved complete remission (CR) or partial remission (PR) after treatment (primary outcome measure of phase II) |
| Secondary | Objective response rate (ORR) | At the end of induction cycle 6 (each cycle is about 28 days) | Proportion of patients who achieved complete remission (CR) or partial remission (PR) after treatment (secondary outcome measure of phase I) |
| Secondary | Progression Free Survival | All enrolled patients were followed up for at least 12 months or had an event | Time from enrollment to confirmation of disease progression or death from any cause (secondary outcome measure of phase II) |
| Secondary | Time to Next Treatment (TTNT) | All enrolled patients were followed up for at least 12 months or had an event | The interval from commencement of one treatment to initiation of the next line of therapy (secondary outcome measure of phase II) |
| Secondary | Adverse Events | From enrollment to 28 days after the end of treatment | Adverse Events (CTCAE v6.0), Vital Signs and Physical Examination, ECOG, Clinical Laboratory Tests, Electrocardiogram (ECG), Echocardiography, Cardiac Enzyme Profile |
| Secondary | Change in quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status score | From enrollment to 28 days after the end of treatment | Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status score ranges from 0 to 100, with higher scores indicating better quality of life. Scores will be calculated according to the EORTC scoring manual and summarized as change from baseline. |
| Secondary | Cancer-related fatigue as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score | From enrollment to 28 days after the end of treatment | Cancer-related fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Scores are reported as T-scores standardized to a reference population, with higher scores indicating greater fatigue (worse outcome). Changes from baseline will be summarized. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07535710
GET https://conductscience.org/api/trials/v1/NCT07535710/registered