AzTrials
AzTrials

Mantle Cell LymphomaPhase 2NCT06656221

A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

A Phase 2 study testing Obinutuzumab, Glofitamab and Bortezomib in people with Mantle Cell Lymphoma, run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell lymphoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Obinutuzumab, Glofitamab and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
No sites listed yet
Study dates
1 Dec 2024to 1 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Age ≥ 18 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
  • Participants with MCL
  • Meets any of the following high-risk criteria: blastoid/pleomorphic morphology; high Ki-67 (≥ 30%); TP53 aberration; del(17p); complex karyotype; MIPI score ≥ 6.2; early progression after first-line treatment (<24 months); presence of other high-risk genetic mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1)
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
Show all 11Show fewer
  • At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan
  • No bone marrow involvement: ANC ≥ 1.0 × 10^9/L; bone marrow involvement: ANC ≥ 0.5 × 10^9/L
  • No bone marrow involvement: PLT ≥ 75 × 10^9/L; bone marrow involvement: PLT ≥ 25 × 10^9/L
  • No bone marrow involvement: Hgb ≥ 8 g/dL; bone marrow involvement: Hgb ≥ 7 g/dL
  • Adequate renal function, defined as measured or estimated creatinine clearance ≥ 30 mL/min

Who cannot join

  • Contraindication to any of the individual components of Glofit-Orela-Borte
  • Known active infection at the time of enrollment
  • Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology): Patients with occult or prior HBV infection (defined as negative HbsAg and positive hepatitis B core antibody [HbcAb]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy
  • Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing): Patients who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA
  • History of other malignancies that could affect compliance with the protocol or interpretation of results
  • Active autoimmune disease requiring treatment
  • Primary or secondary CNS lymphoma at the time of recruitment
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications

About this study

The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell lymphoma

Being tested
Obinutuzumab, Glofitamab, Bortezomib, Orelabrutinib
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2

  • GlofitamabDrug

    Glofitamab is given intravenously at a dose of 2.5mg on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg on Day 1 of Cycles 2-6

  • BortezomibDrug

    Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.

  • OrelabrutinibDrug

    Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.

Study groups in NCT06656221
Study groupRoleWhat they receive
Glofitamab-Orelabrutinib-BortezomibExperimentalParticipants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12. Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12. Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12. The duration of one cycle is 21 days.
Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Bortezomib; Drug: Orelabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response (CR) Rate

    CR rate, defined as the proportion of patients with a best overall response of CR at any time during the study, as determined by the investigator using 2014 Lugano Response Criteria

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR, defined as the proportion of patients with a best overall response of CR or PR at any time during the study, as determined by the investigator using 2014 Lugano Response Criteria.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. Duration of Complete Response (DoCR)

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

    Measured: Up to 2 years

  4. Progression-Free Survival (PFS)

    PFS, defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator using 2014 Lugano Response Criteria.

    Measured: Up to 2 years

  5. Overall Survival (OS)

    OS, defined as the time from the first study treatment to the date of death from any cause.

    Measured: Up to 2 years

  6. Incidence and severity of adverse events

    Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 grading scale, except CRS that shall be graded using ASTCT CRS grading criteria 2019

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656221
Sponsor's protocol ID
Glo-MCL
Status last verified
Nov 2024
First submitted
23 Oct 2024
Last updated
19 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab, Glofitamab and Bortezomib in people with Mantle Cell Lymphoma, run by Ruijin Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR) Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in