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Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma

ConditionsMCLRelapsed or Refractory Mantle Cell Lymphoma (MCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor.

Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy.

Glofitamab will be administered intravenously and lenalidomide will be self-administered orally.

Obinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET/CT according to Lugano criteria during study enrolment.

The primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Signed Informed Consent Forms

Age: >= 18 to 80 years

Eastern Cooperative Oncology Group =< 2

Diagnosis of MCL established by histologic assessment

Disqualifiers

• Already enrolled in other Ongoing interventional or non-interventional R/R MCL clinical trials;

Currently receiving immunosuppressive treatment for other diseases;

Previous treatment with lenalidomide;

Combined with other malignant tumors within 3 years;

Trial design

Design model

Single group

Treatments tested in this trial

  • Glofitamab

    Drug

    Glofitamab is a human IgG1-bispecific antibody targeting CD20 expressed on the surface of B cells and CD3ɛ chain expressed on the surface of T cells.

  • Lenalidomide

    Drug

    Lenalidomide is an agent with immunomodulatory and anti-angiogenic properties which confer multiple antitumor effects.

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTKiExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction.

to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction, defined as the percent of patients who achieve a best complete response (CR) or partial response (PR) according to the 2014 Lugano response criteria for non-Hodgkin lymphoma at the end of induction.

Time frame
24 months

Secondary outcomes

1

Objective Response Rate (ORR)

ORR, defined as the proportion of patients with overall response rate at C6 and the end of induction, as determined by the investigator using 2014 Lugano Response Criteria.

Time frame
up to 24 months
2

complete response rate (CRR)

CRR, defined as the proportion of patients with complete response rate（CRR）at C6 and the end of induction, and a best overall response of CR at any time during the studas determined by the investigator using 2014 Lugano Response Criteria.

Time frame
Up to 24 months
3

Duration of Response (DoR)

DoR, defined as the time from the first occurrence of a documented objective response (PR or CR) to disease progression or death from any cause (whichever occurs first) according to the 2014 Lugano Response Criteria, as determined by the investigator.

Time frame
Up to 48 months
4

Duration of Complete Response (DoCR)

DoCR, defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first according to the 2014 Lugano Response Criteria, as determined by the investigator.

Time frame
Up to 48 months

Other outcomes

1

To evaluate the safety profiles of Glofitamab combined with lenalidomide in the treatment of high-risk mantle cell lymphoma

List the number and frequency of hematological and non-hematological toxicity (NCI CTCAE v5.0) and calculate the incidence rate.

Time frame
48 months

Sponsors and contacts

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

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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