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Diffuse Large B Cell LymphomaPhase 2NCT03949062

Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

A Phase 2 study testing Ibrutinib, Lenalidomide and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。 Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Ibrutinib, Lenalidomide and Rituximab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
13 Mar 2019to May 2022
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Pathologically confirmed diffuse large B cell lymphoma, treatment naive
  • Age > 75 years
  • Ineligible for standard chemotherapy
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • At least 3 months life expectation
  • Informed consented
  • No previous use of study drug

Who cannot join

  • Has accepted Chemotherapy before
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
  • Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
  • HIV infection
  • If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
  • Other uncontrollable medical condition that may that may interfere the participation of the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma

This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。

Read the detailed description

This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.

Keywords
iR2
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.

  • IbrutinibDrug

    Also called Imbruvica

    Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles

  • LenalidomideDrug

    Also called Relvimid

    Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles

  • RituximabDrug

    Also called Rituxan

    Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles

Study groups in NCT03949062
Study groupRoleWhat they receive
iR2ExperimentalParticipants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
Receives: Drug: Ibrutinib; Drug: Lenalidomide; Drug: Rituximab

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 was determined on the basis of investigator assessments according to 2014 Lugano criteria

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

Secondary outcomes (4)

  1. Overall response rate

    Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria

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

  2. Progression free survival

    Progression-free survival was defined as the time from the date of diagnosis 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 4 years)

  3. Overall survival

    Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up to data cut-off (up to approximately 4 years)

Timeline

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

  1. First posted14 May 2019
  2. Study start13 Mar 2019
  3. Primary completionMar 2021 (estimated)
  4. Study completionMay 2022 (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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949062
Sponsor's protocol ID
NHL-iR2
Status last verified
Feb 2021
First submitted
10 May 2019
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu PP, Shi ZY, Qian Y, Cheng S, Zhu Y, Jiang L, Li JF, Fang H, Huang HY, Yi HM, Ouyang BS, Wang L, Zhao WL. Ibrutinib, rituximab, and lenalidomide in unfit or frail patients aged 75 years or older with de novo diffuse large B-cell lymphoma: a phase 2, single-arm study. Lancet Healthy Longev. 2022 Jul;3(7):e481-e490. doi: 10.1016/S2666-7568(22)00123-4.

    PubMed 36102758

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib, Lenalidomide and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital 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 7 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 17 Feb 2021. 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?

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 rate (time frame: At the end of 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 NCT03949062, which also lists 1 linked publication.

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 17 Feb 2021.

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