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Phase 1, Phase 2Not yet recruitingPriority 3 · Moderate priorityNCT07535710

Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is testing Aclarubicin, Cyclophosphamide, and other medications for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 60 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Aclarubicin (DRUG): Cycle 1-6: Phase I starting dose 20mg/m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results Cycle 7-10: Phase I starting dose 20mg/ m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results | Cyclophosphamide (DRUG): Cycle 1-6 750 mg/m\^2, D1, QD, ivgtt Cycle 7-10 750 mg/m\^2, D1, QD, ivgtt | Vincristine (DRUG): Cycle 1-6 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv Cycle 7-10 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv | Prednisone (DRUG): Cycle 1-6 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po Cycle 7-10 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po

Drugs / treatments
Aclarubicin, Cyclophosphamide, Vincristine, Prednisone
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1, Phase 2
Status
Not yet recruiting
Design
Non-randomized, open-label
Enrollment target
37 patients
Primary endpoint
Maximum tolerated dose (MTD); Recommended Phase 2 Dose (RP2D); Objective response rate (ORR)
Ages
60 Years to —
Start date
2026-03-30
Est. completion
2028-12-31

Locations

0 US sites · 2 total

No US sites currently listed.

Contact

Sponsor
Shanghai Jiao Tong University School of Medicine (OTHER)
Contact
Jiong Hu | hj10709@rjh.com.cn | 86-13764313546

Tags

CTCLRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma

NCT07535710

Phase: Phase 1, Phase 2 | Status: Not yet recruiting | Priority: Medium

Plain-language summary

This Phase 1, Phase 2 trial is testing Aclarubicin, Cyclophosphamide, and other medications for people whose cutaneous T-cell lymphoma (skin lymphoma) has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join

  • Age 60 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

Aclarubicin (DRUG): Cycle 1-6: Phase I starting dose 20mg/m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results Cycle 7-10: Phase I starting dose 20mg/ m\^2/D, D1-2 (dose group 1), D1-3 (dose group 2), D1-4 (dose group 3), QD, ivgtt The Phase II dose was determined based on the Phase I results | Cyclophosphamide (DRUG): Cycle 1-6 750 mg/m\^2, D1, QD, ivgtt Cycle 7-10 750 mg/m\^2, D1, QD, ivgtt | Vincristine (DRUG): Cycle 1-6 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv Cycle 7-10 1.4 mg/m\^2, D1 (maximum 2mg/d), QD, iv | Prednisone (DRUG): Cycle 1-6 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po Cycle 7-10 60 mg/m\^2, D1-5 (maximum 100mg/d), QD, Po

Drugs / treatments: Aclarubicin, Cyclophosphamide, Vincristine, Prednisone

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 37 patients

Primary endpoint: Maximum tolerated dose (MTD); Recommended Phase 2 Dose (RP2D); Objective response rate (ORR)

Ages: 60 Years to —

Start date: 2026-03-30 | Est. completion: 2028-12-31

Locations

0 US sites · 2 total

Contact

Jiong Hu | hj10709@rjh.com.cn | 86-13764313546

Sponsor: Shanghai Jiao Tong University School of Medicine (OTHER)

Tags

CTCL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07535710

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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