Health TrialsbyHealthPanel

Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

ConditionEnteropathy Associated T Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Current use (or inability to discontinue use) of strong CYP3A inducers (within at least 3 weeks) or strong inhibitors (within at least 1 week) prior to the first dose;

Prior use of JAK or STAT3 inhibitors;

Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue these medications within 1 week prior to the first dose);

Vaccination with live vaccines within 28 days prior to the first dose (except for attenuated influenza vaccines);

Trial design

Design model

Single group

Treatments tested in this trial

  • Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)

    Drug

    Induction Treatment: Golidocitinib:150mg QD Cyclophosphamide:750mg/m2，d1 vincristine:1.4mg/m2，d1(max 2mg) doxorubicin:50mg/m2，d1 Prednisone:60mg/m2 (max 100mg)，d1-d5 Every 21 days

  • Golidocitinib

    Drug

    Maintenance Treatment: Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT.

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: Go-CHOPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response Rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
At the end of Cycle 6 (each cycle is 21days)

Secondary outcomes

1

Progression-free survival

Progression-free survival was defined as the time from the date of randomization 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
Baseline up to data cut-off(up to approximately 3 years)
2

Objective Response Rate

Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
At the end of Cycle 6 (each cycle is 21days)
3

Duration of Response

Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.

Time frame
Baseline up to data cut-off(up to approximately 3 years)
4

Overall survival

Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
Baseline up to data cut-off(up to approximately 3 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: