Diffuse Large B-Cell LymphomaPhase 2NCT06441097
Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Ruijin Hospital.
Trial summary
The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Polatuzumab vedotin, Rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- Previously untreated participants with CD20-positive DLBCL
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
- After 1 cycle of Pola-R-CHP, ctDNA decreased by < 3.0 LFC
Show all 12Show fewer
- Life expectancy ≥ 6 months
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:
- Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment
- ANC ≥ 1.0 x 10^9/L
- PLT ≥ 75 x 10^9/L
Who cannot join
- Contraindication to any of the individual components of Pola-RCHP or Acalabrutinib/Lenalidomide/ Decitabine
- Prior solid organ transplantation or SCT
- Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible
- Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
Show all 35Show fewer
- Participants receiving adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for ≥ 2 years prior to enrollment are eligible
- Participants with any other malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
- Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
- History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 4 weeks before the start of Cycle 1
- Active autoimmune disease which is not well controlled by therapy
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible
- Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- Participants with active autoimmune disease with dermatologic manifestations are eligible for the study
- Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded
- Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
- ANC < 1.0 x 10^9/L
- PLT < 75 x 10^9/L
- Serum AST and ALT ≥ 2.5 x ULN
- Total bilirubin ≥ 1.5 x ULN
- Serum creatinine clearance < 30 mL/min (using Cockcroft-Gault formula)
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
- Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
- Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- Participants with a history of progressive multifocal leukoencephalopathy
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of Pola-RCHP-X
- Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
- 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 vedotinDrug
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
RituximabDrug
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO will be administered as per the schedule specified in the respective arm.
AcalabrutinibDrug
Acalabrutinib PO will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DecitabineDrug
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Pola-RCHP-X | Experimental | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive Acalabrutinib 100 mg BID PO on days 1-21, or lenalidomide 25 mg/day PO on days 1-10, or decitabine 10 mg/m²/day IV on days -5 to -1 followed by standard Pola-RCHP of every 21-day cycle. Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Acalabrutinib; Drug: Lenalidomide; Drug: Decitabine |
| Pola-RCHP | Active comparator | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles. Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（by IRC）
PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
Measured: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
Secondary outcomes (6)
Progression-free survival（by the investigator）
PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
Measured: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
Event-free survival
defined as the time from date of randomization to the earliest occurrence of any of the following:
- Disease progression/relapse as determined by the investigator and IRC (separately)
- Death due to any cause
- The primary efficacy reason determined by the investigator, other than disease progression/relapse, that leads to initiation of NALT
- If biopsy is obtained after treatment completion and is positive for residual disease regardless of whether NALT is initiated or not
Measured: up to approximately 24 months
Complete response rate
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Objective response rate
ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
OS defined as the time from randomization to death from any cause
Measured: up to approximately 2 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
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: From enrollment to study completion, a maximum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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.
- More trials run by Ruijin HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441097
- Sponsor's protocol ID
- GUIDANCE-005
- Status last verified
- Jun 2024
- First submitted
- 26 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06441097
- Acronym / sponsor ID
- GUIDANCE-005
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 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.
The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pola-RCHP-X | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Acalabrutinib, Drug: Lenalidomide, Drug: DecitabineParticipants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive Acalabrutinib 100 mg BID PO on days 1-21, or lenalidomide 25 mg/day PO on days 1-10, or decitabine 10 mg/m²/day IV on days -5 to -1 followed by standard Pola-RCHP of every 21-day cycle. |
| Pola-RCHP | Active comparator | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneParticipants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2， doxorubicin 50 mg/m² IV on Day 2 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed Informed Consent Form
- Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- Previously untreated participants with CD20-positive DLBCL
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
Key exclusion criteria (35 listed)
- Contraindication to any of the individual components of Pola-RCHP or Acalabrutinib/Lenalidomide/ Decitabine
- Prior solid organ transplantation or SCT
- Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
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 vedotinPolatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| RituximabRituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP, Pola-RCHP-X |
| AcalabrutinibAcalabrutinib PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X |
| DecitabineDecitabine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Pola-RCHP-X |
Primary outcome
Progression-free survival（by IRC）
Time frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
6 secondary outcomes
Progression-free survival（by the investigator）
Time frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
Event-free survival
Time frame: up to approximately 24 months
Complete response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Objective response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
Time frame: up to approximately 2 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to study completion, a maximum of 3 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 4 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Ruijin Hospital.
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 12 inclusion and 35 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: opening soon, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Weili Zhao (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（by IRC） (time frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (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 4 Jun 2024.