UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057974 |
|---|---|
| Receipt number | R000066280 |
| Scientific Title | A Phase II Study of Frailty Score Guided Dose Intensity Adjustment of Polatuzumab Vedotin plus R-CHP in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (Pola-FIT trial) |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/05/26 18:19:38 |
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Basic information
Public title
A Phase II Study Evaluating the Efficacy and Safety of Frailty Score Guided Dose Intensity Adjustment of Polatuzumab Vedotin plus R-CHP in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma
Acronym
Pola-FIT trial
Scientific Title
A Phase II Study of Frailty Score Guided Dose Intensity Adjustment of Polatuzumab Vedotin plus R-CHP in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (Pola-FIT trial)
Scientific Title:Acronym
Pola-FIT trial: Polatuzumab vedotin with Frailty Score Guided Intensity Adjusted Therapy in Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma
Region
| Japan |
Condition
Condition
Diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase II trial aims to evaluate the efficacy and safety of frailty score guided dose-adjusted polatuzumab vedotin in combination with R-CHP-comprising rituximab, cyclophosphamide, doxorubicin, and prednisone-for six cycles in elderly patients with newly diagnosed diffuse large B-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 2-year overall survival rate (2-year OS) will be estimated as a secondary endpoint. Overall survival is defined as the time from the date of enrollment to death from any cause. Patients who are lost to follow-up will be censored at the date of last confirmed survival. Overall survival will be analyzed in the full analysis set. Annual survival rates will be estimated using the Kaplan-Meier method. The 95% confidence interval (CI) for the median overall survival will be calculated using the method of Brookmeyer and Crowley, while the 95% CI for annual survival rates will be derived using Greenwood s formula.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Polatuzumab vedotin plus R-CHP (Pola-R-CHP) will be administered every 3 weeks for a total of 6 cycles. If the scheduled date for the subsequent cycle falls on a weekend or national holiday, the timing may be adjusted at the discretion of the investigator.
Dose Modification Based on Frailty Score and Age
Patients aged 70-79 years:
Fit: Full-dose Pola-R-CHP will be administered as follows:
Cyclophosphamide (CPA): 750 mg/m2, IV on Day 2 of each cycle (Cycles 1-6)
Doxorubicin (DXR): 50 mg/m2, IV on Day 2 of each cycle (Cycles 1-6)
Prednisolone (PSL): 100 mg/body, orally or IV on Days 2-6 (Cycles 1-6)
Rituximab (RTX): 375 mg/m2, IV on Day 1 (Cycles 1-6)
Polatuzumab vedotin (Pola): 1.8 mg/kg, IV on Day 2 (Cycles 1-6)
Unfit/Frail: An 80% dose of CHP will be administered with full-dose RTX and Pola:
CPA: 600 mg/m2, IV on Day 2
DXR: 40 mg/m2, IV on Day 2
PSL: 80 mg/body, orally or IV on Days 2-6
RTX: 375 mg/m2, IV on Day 1
Pola: 1.8 mg/kg, IV on Day 2
Patients aged 80 years or older:
Fit: 80% dose-reduced CHP will be administered with full-dose RTX and Pola:
CPA: 600 mg/m2, IV on Day 2
DXR: 40 mg/m2, IV on Day 2
PSL: 80 mg/body, orally or IV on Days 2-6
RTX: 375 mg/m2, IV on Day 1
Pola: 1.8 mg/kg, IV on Day 2
Unfit/Frail: Approximately 50% dose of CHP will be administered:
CPA: 400 mg/m2, IV on Day 2
DXR: 25 mg/m2, IV on Day 2
PSL: 40 mg/m2, orally or IV on Days 2-6
RTX: 375 mg/m2, IV on Day 1
Pola: 1.8 mg/kg, IV on Day 2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Study Population
Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who are either hospitalized or receiving outpatient care at the Department of Oncology, Tokyo Metropolitan Komagome Hospital, will be considered eligible for enrollment.
(2) Inclusion Criteria
Patients must meet all of the following criteria to be eligible for study participation:
- Age >= 70 years at the time of informed consent.
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (4th revised edition), including cases of histologic transformation and high-grade B-cell lymphoma with MYC and BCL2 rearrangements, as well as follicular lymphoma grade 3B.
- CD20 expression on tumor cells confirmed by immunohistochemistry or flow cytometry using biopsy or surgically resected specimens.
- Presence of at least one measurable lesion as determined by imaging studies.
- WHO performance status of 0 to 3.
- Written informed consent voluntarily provided by the patient after receiving a full explanation of the study and demonstrating adequate understanding of its nature and purpose.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
- Primary central nervous system lymphoma (including intraocular lymphoma), or evidence of central nervous system involvement at diagnosis based on cerebrospinal fluid analysis or neuroimaging.
- Hepatic dysfunction defined as total serum bilirubin >= 3.0 mg/dL and/or AST >= 3 times the institutional upper limit of normal.
- Renal impairment defined as serum creatinine >= 2.0 mg/dL.
- Hematologic abnormalities: absolute neutrophil count <= 1000/uL or platelet count <= 75000/uL, unless cytopenia is attributable to bone marrow infiltration by lymphoma.
- Positive test for human immunodeficiency virus (HIV) antibodies.
- Presence of active, serious infections requiring systemic treatment.
- History of psychiatric disorders or psychiatric symptoms deemed by the investigator to interfere with the patient's ability to participate in the study.
- Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yagi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Division name
Department of Medical Oncology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL
03-3823-2101
yuu_yagi@tmhp.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Yagi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Division name
Medical Oncology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan
TEL
03-3823-2101
Homepage URL
yuu_yagi@tmhp.jp
Sponsor or person
Institute
Clinical Research Unit, Tokyo Metropolitan Komagome Hospital, Tokyo Metropolitan Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Unit, Tokyo Metropolitan Komagome Hospital, Tokyo Metropolitan Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan
Tel
0338232101
yuu_yagi@tmhp.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
がん・感染症センター都立駒込病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066280
