Health TrialsbyHealthPanel

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

ConditionsFollicular LymphomaRelapsed and Refractory Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed grade 1, 2, or 3A FL;

Patients received prior anti-lymphoma treatment;

At least one evaluable lesion according to 2014 Lugano criteria;

Age 18 years or older;

Disqualifiers

Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;

Histological transformation of follicular lymphoma;

Known central nervous system lymphoma;

Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib and Rituximab

    Drug

    Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.

  • Orelabrutinib

    Drug

    Orelabrutinib 150mg po qd

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Orelabrutinib plus Rituximab followed by Maintenance with OrelabrutinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response rate

Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
2 years

Secondary outcomes

1

Complete remission rate

Complete remission rate will be determined on the basis of investigator

Time frame
2 years
2

Progression Free Survival

The time from the start of treatment to the progression of the tumor or death (due to any cause).

Time frame
4 years
3

Overall Survival

The time from the start of treatment to time of death (due to any cause).

Time frame
4 years
4

Duration of Response

The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).

Time frame
4 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
Apply now