Transformed LymphomaPhase 2NCT06743945
POLA-R-CHP in the First-line Treatment of Transformed DLBCL
A Phase 2 study testing POLA-R-CHP in people with Transformed Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transformed Lymphoma
- What is being tested?
- POLA-R-CHP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to Dec 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 -80 years old;
- Histologically confirmed transformed DLBCL;
- ECOG 0-2;
- Signed informed consent form.
- Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 90g/L(unless caused by underlying disease, as judged by the investigator, such as extensive bone marrow involvement, or hypersplenism secondary to lymphoma splenic involvement); b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography.
Who cannot join
- Individuals who are allergic to human or mouse monoclonal antibodies, or known sensitivity or allergic reaction to murine products;
- Previous organ transplantation;
- Prior treatment of any condition (e.g., cancer, rheumatoid arthritis) with cytotoxic drugs within 5 years at the time of screening or prior use of any anti-CD20 antibodies;
- Evidence of uncontrolled significant comorbidities that may affect the patient's compliance with the study protocol or affect the interpretation of the study results, including significant cardiovascular disease (such as New York College of Cardiology Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) or pulmonary disease (including history of obstructive pulmonary disease and bronchospasm);
- Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
- Known active bacterial, viral, fungal, mycobacterial, parasitic or other infections (except for fungal infections in nail beds) at the time of study enrollment or major infections within 2 weeks before the start of the first course of treatment;
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- Previous radiotherapy in the mediastinum/pericardial region;
- Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive hepatitis B surface antigen or hepatitis B core total antibody) can be included in this study. The above patients must voluntarily undergo regular HBV-DNA testing and receive appropriate antiviral treatment according to regulations.
- For patients with positive hepatitis C virus (HCV) antibody serological test, only when polymerase chain reaction (PCR) shows negative HCV-RNA can participate in this study.
- Patients with active HIV and syphilis infections;
- Pregnant or lactating women;
- The researcher determined that patients are not suitable to participate in this study.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yizhen Liu, 021-64175590 ext. 85100, aliuyz@126.com
About this study
Official title: A Prospective, Multicenter, Phase II Study of POLA-R-CHP in the First-line Treatment of Transformed DLBCL
This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.
Read the detailed description
Patients with transformed DLBCL lack standard treatment. We intend to conduct a prospective, multicenter, phase II study in order to evaluate efficacy and safety of POLA-R-CHP as first-line treatment of patients with transformed DLBCL.
- Conditions
- Transformed Lymphoma
- Being tested
- POLA-R-CHP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLA-R-CHPDrug
Also called polatuzumab vedotin and R-CHP
Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | POLA-R-CHP Receives: Drug: POLA-R-CHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS) assessed by imaging examination
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Measured: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Secondary outcomes (4)
complete remission rate assessed by imaging examination
the ratio of numbers of patients with complete response after 6 treatment cycles to all the participants
Measured: up to 6 months
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Measured: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival rate
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Measured: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Through study completion, 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.
- First posted20 Dec 2024
- Study start17 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transformed LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhen Liu, Fudan University
- Investigators
- Yizhen Liu, M.D., Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743945
- Sponsor's protocol ID
- iNHL-05
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2024
- Last updated
- 25 Feb 2025
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase II Study of POLA-R-CHP in the First-line Treatment of Transformed DLBCL
- ClinicalTrials.gov ID
- NCT06743945
- Acronym / sponsor ID
- iNHL-05
- Conditions
- Transformed Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Dec 2024 (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 study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.
Detailed description
Patients with transformed DLBCL lack standard treatment. We intend to conduct a prospective, multicenter, phase II study in order to evaluate efficacy and safety of POLA-R-CHP as first-line treatment of patients with transformed DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: POLA-R-CHPPOLA-R-CHP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 -80 years old;
- Histologically confirmed transformed DLBCL;
- ECOG 0-2;
- Signed informed consent form.
- Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 90g/L(unless caused by underlying disease, as judged by the investigator, such as extensive bone marrow involvement, or hypersplenism secondary to lymphoma splenic involvement); b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography.
Key exclusion criteria (12 listed)
- Individuals who are allergic to human or mouse monoclonal antibodies, or known sensitivity or allergic reaction to murine products;
- Previous organ transplantation;
- Prior treatment of any condition (e.g., cancer, rheumatoid arthritis) with cytotoxic drugs within 5 years at the time of screening or prior use of any anti-CD20 antibodies;
- Evidence of uncontrolled significant comorbidities that may affect the patient's compliance with the study protocol or affect the interpretation of the study results, including significant cardiovascular disease (such as New York College of Cardiology Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) or pulmonary disease (including history of obstructive pulmonary disease and bronchospasm);
- Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
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 |
|---|---|---|
| POLA-R-CHPAlso: polatuzumab vedotin and R-CHPPola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin | Drug | Experimental group |
Primary outcome
2-year progression-free survival (PFS) assessed by imaging examination
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
4 secondary outcomes
complete remission rate assessed by imaging examination
Time frame: up to 6 months
2-year event-free survival (EFS)
Time frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival rate
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, up to 2 years
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 25 Feb 2025.
- 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.
Yizhen Liu, M.D., Ph.D. principal investigator
Fudan University
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 POLA-R-CHP in people with Transformed Lymphoma, run by Fudan 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 5 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. 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 Yizhen Liu, M.D., Ph.D. (021-64175590, aliuyz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) assessed by imaging examination (time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years). 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 25 Feb 2025.