Health TrialsbyHealthPanel

Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas

ConditionsRelapsed Peripheral T-Cell LymphomasRefractory Peripheral T-Cell Lymphomas
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing

About this trial

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;

Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;

Patient is willing and able to adhere to the study visit schedule and other protocol requirements;

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;

Pregnant or lactating women

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacytidine plus CAOLD regimen

    Drug

    Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Azacytidine plus CAOLD regimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR was defined as the proportion of patients who achieved CR or PR as their best response

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 2 year
2

Progression Free Survival (PFS)

PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
Apply now