Diffuse Large B Cell LymphomaPhase 2NCT06176729
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
A Phase 2 study testing Polatuzumab Vedotin, Rituximab, Lenalidomide in people with Diffuse Large B Cell Lymphoma, run by Yan Zhang, MD at 1 site in China.
Trial summary
This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Polatuzumab Vedotin, Rituximab, Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 24 Oct 2027
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The patient volunteered to participate in the study and signed the Informed Consent
- Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
- Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
- Adequate organ function and adequate bone marrow reserve
Who cannot join
- Coexisting malignancy other than lymphoma
- Active HBV infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wei Wang, MD, +8613810131294, wangweipumc@163.com
About this study
Official title: A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).
Read the detailed description
In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.
The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Polatuzumab Vedotin, Rituximab, Lenalidomide
- 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.
Polatuzumab Vedotin, Rituximab, LenalidomideDrug
polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Pola-R2 regimen Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days Receives: Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
proportion of patients achieving complete remission
Measured: evaluated every 3 months，up to 24 months
Secondary outcomes (4)
overall remission rate
proportion of patients achieving at least partial remission
Measured: evaluated every 3 months，up to 24 months
2 year progression-free survival rate
time from treatment to the time of disease progression or death of any reason
Measured: 2 years after last patient included
2 year overall survival rate
time from treatment to the time of death of any reason
Measured: 2 years after last patient included
any adverse event occurred during this study
safety
Measured: 2 years after last patient included
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start24 Oct 2023
- Primary completion24 Oct 2025 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Zhang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University First Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Yan Zhang, MD, Peking Union Medical College Hospital
- Investigators
- Yan Zhang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176729
- Sponsor's protocol ID
- 2022-PUMCH-A-194
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
- ClinicalTrials.gov ID
- NCT06176729
- Acronym / sponsor ID
- 2022-PUMCH-A-194
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yan Zhang, MDUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University First Hospital, Chinese PLA General Hospital
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 24 Oct 2025 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).
Detailed description
In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.
The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Polatuzumab Vedotin, Rituximab, LenalidomidePola-R2 regimen Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- The patient volunteered to participate in the study and signed the Informed Consent
- Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
- Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
- Adequate organ function and adequate bone marrow reserve
Key exclusion criteria (3 listed)
- Coexisting malignancy other than lymphoma
- Active HBV infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab Vedotin, Rituximab, Lenalidomidepolatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days | Drug | Experimental arm |
Primary outcome
complete remission rate
Time frame: evaluated every 3 months，up to 24 months
proportion of patients achieving complete remission
4 secondary outcomes
overall remission rate
Time frame: evaluated every 3 months，up to 24 months
2 year progression-free survival rate
Time frame: 2 years after last patient included
2 year overall survival rate
Time frame: 2 years after last patient included
any adverse event occurred during this study
Time frame: 2 years after last patient included
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Zhang, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab Vedotin, Rituximab, Lenalidomide in people with Diffuse Large B Cell Lymphoma, run by Yan Zhang, MD 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 4 inclusion and 3 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 20 Dec 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 Wei Wang, MD (+86 13810131294, wangweipumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: evaluated every 3 months，up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.