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AzTrials

Diffuse Large B Cell LymphomaPhase 2NCT05428670

The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.

A Phase 2 study testing Zanubrutinib+Rituximab+Lenalidomide and RCHOP/RCDOP in people with Diffuse Large B Cell Lymphoma, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Zanubrutinib+Rituximab+Lenalidomide and RCHOP/RCDOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
15 Jun 2022to 30 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Pathologically confirmed DLBCL
  • Without treatment
  • ≥ 65 years old
  • Measurable lesions on CT or PET-CT before treatment
  • Life expectancy of at least 3 months
  • Voluntary participation with the consent of the patient
  • Heart, kidney, liver and other organ function evaluation were basically normal before treatment

Who cannot join

  • Patients who previously received chemotherapy
  • Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases
  • Laboratory indicators before enrollment (unless caused by lymphoma):
  • Neutrophils < 1.5 × 10^9/L
  • Platelets < 80 × 10^9/L
  • Alanine aminotransferase or aspartate aminotransferase > 2 × ULN
Show all 12Show fewer
  • Alkaline phosphatase or bilirubin > 1.5 × ULN
  • Creatinine > 1.5 × ULN
  • Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation
  • HIV infection
  • If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled
  • Other uncontrolled medical conditions that may interfere with the study

Trial locations and contacts

1 site in 1 country.

Haige Ye, Ph.D contact

+8615967413188

haigeye@wzhospital.cn

China1 site, 1 recruiting

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Xian Shen, Ph. D, +86057755578055, wyyyclinical@126.com

    Recruiting

Other trials in China

About this study

This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.

Read the detailed description

In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions between the RCHOP/RCDOP chemotherapy and the ZR2 regimen. In addition, immune function tests will be performed before treatment and every 2 courses after treatment, including peripheral blood lymphocyte-monocyte ratio, cytokines, immunoglobulins, T and B cells and their quantitative analysis. Patients with ZR2 regimen will undergo gene second-generation sequencing before treatment to compare the gene mutation differences between complete response (CR) and ≤ partial response (PR) in the efficacy of ZR2 regimen, in order to find biomarkers with better efficacy in ZR2 treatment. Moreover, investigators intend to conduct pharmacokinetics/pharmacodynamics (PK/PD) correlation analysis of ZR2 regimen and pharmacoeconomic evaluation of the two regimens.

Being tested
Zanubrutinib+Rituximab+Lenalidomide, RCHOP/RCDOP
Keywords
Diffuse Large B Cell Lymphoma, Zanubrutinib, Elderly patients
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Zanubrutinib+Rituximab+LenalidomideDrug

    Zanubrutinib is a bruton' s tyrosine kinase inhibitor independently developed in China.

  • RCHOP/RCDOPDrug

    RCHOP/RCDOP is the classic treatment of diffuse large B cell lymphoma.

Study groups in NCT05428670
Study groupRoleWhat they receive
Zanubrutinib+Rituximab+LenalidomideExperimentalThe ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Zanubrutinib, 160 mg bid, po, day 2-21; Lenalidomide, 10-20 mg qd, po, day 2-14; Rituximab, 375 mg/m², ivgtt, day 1. Maintenance therapy: Patients who receive complete response or partial response after induction therapy will receive lenalidomide 10-20 mg qd po during 1-21 days in every 28 days, for a maximum of 2 years.
Receives: Drug: Zanubrutinib+Rituximab+Lenalidomide
RCHOP/RCDOPActive comparatorThe RCHOP/RCDOP regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: Rituximab, 375 mg/m², ivgtt, day 1; Cyclophosphamide, 500-750 mg/m², ivgtt, day 2; Doxorubicin, 50 mg/m², ivgtt day 2 (liposomal doxorubicin, 20-30 mg/m², ivgtt day 2 or Epirubicin, 50-60 mg/m², ivgtt day 2); Vincristine, 1.4 mg/m², iv day 2 or vindesine, 3mg/m², iv day 2; Prednisone, 100 mg qd, po day 2-6.
Receives: Drug: RCHOP/RCDOP

What is being measured

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

  1. Complete response rate

    Percentage of participants with complete response is determined on the basis of investigator assessments according to 2014 Lugano criteria.

    Measured: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

Secondary outcomes (8)

  1. Overall survival

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

    Measured: Baseline up to data cut-off (up to approximately 3 years).

  2. Progression free survival

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

    Measured: Baseline up to data cut-off (up to approximately 3 years).

  3. Incidence rate of adverse events

    Percentage of participants with treatment-related adverse events is assessed by CTCAEv4.0.

    Measured: From enrollment to study completion, a maximum of 3 years.

  4. Direct medical costs

    Direct medical costs include personal expenses and medical insurance reimbursement expenses, mainly including examination expenses, disposal expenses, medical expenses, hospitalization expenses, and other expenses.

    Measured: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

  5. EQ-5D scores

    EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is calculated for the pharmacoeconomics analysis to evaluate the quality of life in participants. EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.

    Measured: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).

  6. Maximum plasma concentration

    Maximum plasma concentration (Cmax) is defined as maximum plasma concentration after dose.

    Measured: The Cmax of zanubrutinib is determined at 2h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Cmax of lenalidomide is determined at 1h postdose on day 2 of Cycle 2 (each cycle is 21 days).

  7. Area under the plasma concentration-time curve

    Area under the plasma concentration-time curve (AUC) is defined as the area under the curve from time zero to time of last quantifiable plasma concentration after dose.

    Measured: The AUC of zanubrutinib is determined at predose (0h), 2h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the AUC of lenalidomide is determined at predose (0h), 1h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).

  8. Steady-state trough concentration

    Steady-state trough concentration (Css,min) is defined as minimum plasma concentration after dose.

    Measured: The Css,min of zanubrutinib is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Css,min of lenalidomide is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).

Timeline

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

  1. First posted23 Jun 2022
  2. Study start15 Jun 2022 (estimated)
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 Jun 2025 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05428670
Sponsor's protocol ID
HaigeYe
Status last verified
Jun 2022
First submitted
2 Jun 2022
Last updated
23 Jun 2022
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 Zanubrutinib+Rituximab+Lenalidomide and RCHOP/RCDOP in people with Diffuse Large B Cell Lymphoma, run by First Affiliated Hospital of Wenzhou Medical University 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. 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?

Results are not available in the source record.

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

Contact Haige Ye, Ph.D (+8615967413188, haigeye@wzhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).). 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 NCT05428670.

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 23 Jun 2022.

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