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Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

ConditionCNS Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-80
SponsorRuijin Hospital

About this trial

This study is designed as an open-label, prospective, single-arm, single-center trial aimed at evaluating the efficacy and safety of MTX or Thiotepa combined with Orelabrutinib and standard chemotherapy regimens in the treatment of DLBCL patients with central nervous system involvement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the study and voluntarily sign the informed consent form.

Age: 14-80 years.

Expected survival of more than 3 months, as determined by the investigator.

Pathologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL) of B-cell origin through pathology or flow cytometry.

Disqualifiers

Contraindications to any of the drugs included in the treatment regimen.

History of active liver disease, including viral or other hepatitis or liver cirrhosis (Hepatitis B is defined as HBV-DNA exceeding the upper limit of normal; active Hepatitis C is defined as seropositive for HCV antibodies, but patients with HCV-RNA negative results can be included).

Human immunodeficiency virus (HIV) infection.

Congestive heart failure classified as greater than NYHA Class II by the New York Heart Association; history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib

    Drug

    150 mg qd po. D1-21, 6 cycles, 21 days per cycle For patients continue transplant, maitaining for 1 year follow-up; otherwise maintaining during 2 years of follow-up，unless disease progression or intolerable toxicity occurs.

  • RCHOP+MTX or Thiotepa

    Drug

    rituximab: 375 mg/m2, D0; cyclophosphamide: 750 mg/m2, D1; doxorubicin: 50 mg/m2, D1; vincristine: 1.4 mg/m2, D1; prednisone: 100 mg, D1-5; MTX: 3.5 g/m2, D0; Thiotepa: 40 mg/m2, D3; Induction therapy, 6 cycles, 21 days a cycle

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: MTX or Thiotepa(for MTX-Intolerant Patients) Combined with R-CHOP and Orelabrutinib therapy groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response (CR)

The CR rate is defined as the percentage of participants with CR, on the basis of investigator assessments, according to 2014 Lugano criteria.

Time frame
the end of Cycle 6 (up to approximately 24 weeks)

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.

Time frame
2 years
2

Overall Survival (OS)

Overall survival is defined as the time from the date of first treatment to the date of death from any cause.

Time frame
up to approximately 4 years
3

The Overall Response Rate (ORR)

The ORR is defined as percentage of participants with overall response including complete response (CR) and partial response (PR), on the basis of investigator assessments, according to 2014 Lugano criteria.

Time frame
the end of Cycle 6 (up to approximately 24 weeks)

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: