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A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

ConditionFollicular Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years, regardless of gender;

Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;

Deemed by the investigator to have an indication for treatment and require therapy;

ECOG performance status score of 0-2;

Disqualifiers

Women with a positive serum pregnancy test or who are breastfeeding;

Patients with lymphoma involving the central nervous system (CNS);

Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction <50%;

Patients with grade >2 neuropathy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Orelabrutinib

    Drug

    Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.

  • Tafasitamab

    Drug

    Tafasitamab 12 mg/kg administered by intravenous infusion on Days 1, 4, 8, 15, and 22 in Cycle 1; on Days 1, 8, 15, and 22 in Cycles 2-3; and on Days 1 and 15 from Cycle 4 onward during induction therapy.

  • Lenalidomide

    Drug

    Lenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle during induction therapy and 10 mg orally once daily on Days 1-21 of each 28-day cycle during maintenance therapy.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Orelabrutinib Tafasitamab LenalidomideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at the end of cycle 12, assessed according to the Lugano 2014 classification

Time frame
At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)

Secondary outcomes

1

Complete Response (CR) Rate

The complete response (CR) rate is defined as the percentage of participants who achieve a complete response at the end of cycle 12 , as assessed by the investigator according to the Lugano 2014 classification criteria

Time frame
At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
2

Progression-Free Survival (PFS)

The time from the start of treatment to disease progression or death from any cause.

Time frame
Up to approximately 3 years
3

Rate of Progression of Disease within 24 Months (POD24)

Percentage of participants experiencing disease progression within 24 months from the initiation of treatment

Time frame
24 months
4

Incidence and Severity of Adverse Events (AEs)

Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0.

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

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

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

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