Health TrialsbyHealthPanel

AZA Combined With RCHOP in P53-mutated DLBCL.

ConditionsDLBCL - Diffuse Large B Cell LymphomaTP53
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Primary and secondary central DLBCL;

HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine in combination with R-CHOP

    Drug

    Specified dose on specified days: Azacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg/m2 IV d0 Cyclophosphamide (C) 750mg/m2 IV d1 epirubicin (H) 75mg/m2 IV d1 or liposomal adriamycin (D) 25-30mg/m2 IV d1 Vincristine (O) 1.4mg/m2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: ARCHOPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete remission rate (CR)

CR is evaluated according to the Lugano criteria for lymphoma response.

Time frame
Up to 36 months

Secondary outcomes

1

Partial remission rate (PR)

PR is evaluated according to the Lugano criteria for lymphoma response.

Time frame
Up to 36 months
2

Overall response rate (ORR)

Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.

Time frame
Up to 36 months
3

Progression Free Survival (PFS)

The Kaplan-Meier method will be used to estimate the rate of PFS. PFS was defined as the time from the date of treatment initiation until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Xiamen University

Lead sponsor

Jiangsu Provincial People's Hospital

Collaborator

Sun Yat-sen University

Collaborator

Chinese Academy of Medical Sciences

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Source ClinicalTrials.gov
Apply now