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Marginal Zone LymphomaPhase 2NCT05846750

Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma

A Phase 2 study testing Obinutuzumab and lenalidomide in people with Marginal Zone Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone Lymphoma
What is being tested?
Obinutuzumab and lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
1 Nov 2022to 31 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Histologically confirmed MZL. have a definite diagnosis of MZL
  • Prior treatment with at least one line of systemic lymphoma including prior immunotherapy or chemoimmunotherapy
  • At least one bi-dimensionally measurable nodal lesion (> 1.5 cm in greatest diameter on CT scan or MRI) OR at least one bi-dimensionally measurable extranodal lesion (> 1.0 cm in greatest diameter on CT scan or MRI)
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  • Need for systemic therapy as assessed by the investigator
  • Life expectancy ≥ 3 months
  • Adequate blood function (except for abnormalities considered by the investigator to be due to the underlying disease of lymphoma), defined as follows:
  • Hemoglobin ≥ 7 g/dL; Absolute neutrophil count ≥ 1.0 × 109/L; Platelet count ≥ 50 x 109/L
  • Normal laboratory values:
  • Creatinine clearance ≥ 30 mL/min; Glutathione transaminase(AST) or glutathione aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 2 × ULN (≤ 3 × ULN in patients with Gilbert's syndrome)
  • For men who are not surgically sterile: Agree to use barrier contraception during treatment and for at least 3 months after the last dose of obinutuzumab or lenalidomide or as required by institutional guidelines, whichever is longer. In addition, male patients must agree to have their partner use an alternative method of contraception (e.g., oral contraceptive, intrauterine device, barrier method, or spermicide)
  • For women who are not surgically sterile: use two appropriate methods of contraception, such as oral contraceptives, intrauterine device, or barrier methods, in combination with spermicide for at least 28 days prior to agreeing to start of study medication, during treatment and for at least 12 months after the last dose of either obinutuzumab or lenalidomide, or as required by institutional guidelines, whichever is longer -

Who cannot join

  • Patients who are refractory or resistant to lenalidomide or obinutuzumab, refractory is defined as no response (PR or CR) after the start of treatment, or relapse within 6 months (≤ 2 cycles of prior lenalidomide or obinutuzumab and no exclusion of treatment change for non-refractory reasons)
  • History of serious allergic or anaphylactic reactions to monoclonal antibody therapy
  • Known hypersensitivity to any of the study drugs
  • Known sensitivity to murine products
  • Previous ≥ Grade 3 allergic reactions/Hypersensitivity to thalidomide
  • History of erythema multiforme, Grade 3 rash, or blisters following prior immunomodulatory derivative therapy
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  • Histologically transformed, highly malignant or diffuse large B-cell lymphoma
  • Central nervous system or meningeal involvement by lymphoma
  • Contraindications for the investigational medical product included in the study treatment regimen
  • Positive test for chronic hepatitis B infection (defined as positive HBsAg serology)
  • Hepatitis C positive (hepatitis C virus antibody serology)
  • HIV or Human T-Lymphocytic Leukemia Virus 1 (HTLV1) positive
  • Evidence of any serious, uncontrolled co-morbidities that affect compliance with the protocol or interpretation of results, including but not limited to significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina), or significant pulmonary disease (including history of obstructive pulmonary disease or bronchospasm)
  • Infection caused by known active bacteria, viruses, fungi, or other microorganisms (other than fungal infection of the nail bed), or any major infection requiring intravenous antibiotics or hospitalization (completion of the entire course of antibiotics, except for neoplastic fever) within 4 weeks prior to enrollment
  • Prior malignancy other than lymphoma, unless the subject has a disease-free survival of ≥ 5 years
  • Pregnant or lactating women.
  • Have ≥ Grade 2 neuropathy
  • Participation in another clinical trial using a pharmacological intervention during the trial or within 28 days prior to Cycle 1
  • Corticosteroids within 4 weeks of enrollment, unless administered at a dose equivalent to ≤ 30 mg/day prednisone (within 4 weeks)
  • Past history of progressive multifocal leukoencephalopathy (PML)
  • Live vaccines within 28 days of treatment start
  • History of solid organ transplantation
  • Presence of any serious illness or abnormality in the clinical laboratory test results that, in the opinion of the investigator, would make the patient unable to safely participate and complete this study, or affect protocol compliance or interpretation of results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

shuhua Yi, Dr contact

86-22-23909106

yishuhua@ihcams.ac.cn

Lugui Qiu, Dr contact

86-22-23909172

qiulg@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tian, 300020

    Rui Lyu, 86-22-23909106

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab(GA101) in Combination With Lenalidomide in Relapsed and Refractory(R/R) Marginal Zone Lymphoma (MZL)

This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL).

Read the detailed description

Marginal zone lymphoma (MZL) is incurable, and the vast majority of patients with MZL eventually face disease relapse or progression.

There is no standard second-line treatment for relapsed/refractory MZL, and the synergistic effect of obinutuzumab and lenalidomide has been demonstrated in other indolent lymphomas.

The aim of this trial is to investigate the efficacy and safety of the combination of obinutuzumab (GA101) and lenalidomide in the treatment of R/R marginal zone lymphoma in order to find a safe and effective option for this type of disease.

Keywords
Obinutuzumab, Lenalidomide
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • ObinutuzumabDrug

    Also called GA101

    Induction (6 cycles, every 28 days/cycle): 1000 mg each time, administered on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 ( 8 total infusions)；

    Maintenance(12 cycles, every 2 months/cycle): 12 infusions of 1000 mg every 2 months for 2 years or until disease progression

  • lenalidomideDrug

    Induction( 6 cycles, every 28 days/cycle): 20 mg/day, oral, Dosing on Days 2-22, every 28 days/cycle of Cycles 1-6；

    Maintenance(12 cycles, every 28 days/cycle):10 mg on Days 2-22 of each 28-day cycle, 12 cycles for 1 year or until disease progression

Study groups in NCT05846750
Study groupRoleWhat they receive
Obinutuzumab and lenalidomideExperimentalPatients will be treated with obinutuzumab and lenalidomide for 6 cycles as induction, and the patients who achieve at least a partial response after 6 cycles of induction therapy will be eligible to enter the maintenance phase for 2 years
Receives: Drug: Obinutuzumab; Drug: lenalidomide

What is being measured

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

  1. Overall Remission Rate(ORR)

    Disease response evaluation after 6 cycles will be used to determine the overall remission rate

    Measured: 24 weeks

Secondary outcomes (4)

  1. 2-year Progression Free Survival (PFS24):

    Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    Measured: up to 4.5 years

  2. 2-year Event-Free Survival (EFS24)

    Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.

    Measured: up to 4.5 years

  3. Complete Response Rate (CR)

    Disease response evaluation after 6 cycles will be used to determine the overall remission rate

    Measured: 24 weeks

  4. Overall survival (OS)

    Overall survival will be measured from the date of inclusion to the date of death from any cause.

    Alive patients will be censored at their last date known to be alive

    Measured: up to 4.5 years

Timeline

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

  1. First posted6 May 2023
  2. Study start1 Nov 2022
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 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
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846750
Sponsor's protocol ID
BDHMZL2023
Status last verified
Mar 2023
First submitted
27 Apr 2023
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
Yes
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 and lenalidomide in people with Marginal Zone Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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 14 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact shuhua Yi, Dr (86-22-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Remission Rate(ORR) (time frame: 24 weeks). 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 NCT05846750.

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 Jul 2023.

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