UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055939 |
|---|---|
| Receipt number | R000063864 |
| Scientific Title | Phase II study of gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) plus epcoritamab therapy for older transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/09/17 09:16:49 |
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Basic information
Public title
Phase II study of gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) plus epcoritamab therapy for older transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma
Acronym
GDPR-EPCO
Scientific Title
Phase II study of gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) plus epcoritamab therapy for older transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma
Scientific Title:Acronym
GDPR-EPCO
Region
| Japan |
Condition
Condition
patients aged over 65 years with relapsed/refractory diffuse large B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine the efficacy and safety of gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) plus epcoritamab therapy as salvage chemotherapy for older patients with relapsed and refractory DLBCL who are not eligible for transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year progression-free survival rate
Key secondary outcomes
Efficacy (CR rate and response rate) and safety (types of adverse events, incidence rate), overall survival (OS), time to response, safety of GDP-R therapy (CR rate and response rate), OS, time to response, safety (types of adverse events, incidence rate) and efficacy after initiation of epcoritamab therapy, efficacy according to disease risk (best effect), QOL survey, rate of hospitalization and outpatient treatment, necessity cost
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In this study, we will examine the efficacy and safety of gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) plus epcoritamab therapy as salvage chemotherapy for older patients with relapsed and refractory DLBCL who are not eligible for transplantation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection criteria
Patients who meet the following criteria will be eligible for this study.
1 Be over 65 years old at the time of registration.
Relapsed or refractory cases who have been diagnosed with diffuse large B-cell lymphoma (WHO classification) and have received 3 or more courses of rituximab combination chemotherapy in the past (it is preferable to register first-time relapses and treatment-refractory cases as much as possible). However, patients with multiple recurrences will be eligible if the attending physician deems them appropriate for this study).
2 The biopsy specimen's immunohistochemical staining or flow cytometry is positive for CD20 antigen in tumor cells.
3 Has measurable lesions.
4 ECOG PS at the time of registration is 0 to 2. This may be done after prior administration of PSL.
5 All of the following criteria have been met 2 to 4 weeks before the start of the study, and significant organ functions are maintained.
Neutrophil count is 1,000/microL or more
Platelet count is 50,000/microL or more
Cardiac function ejection fraction 50% or more (echocardiography or myocardial scintigraphy)
PaO2 is 60 mmHg or more by arterial blood gas analysis, or SpO2 is 93% or more by transcutaneous oxygen saturation meter (Room air)
Serum AST or ALT is less than 5 times the facility standard upper limit
Creatinine clearance 30ml/min or more (actual measurement or Cockcroft-Gault)
Patients who have been informed, who have received a sufficient explanation of the content of this study from the study principal (co-participant) physician using the designated consent explanation document, and who have freely given their written consent to participate in this study.
Key exclusion criteria
Exclusion criteria
This study will not include cases that fall under any of the following.
1 B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma (intermediate DLBCL/BL) and Burkitt lymphoma (WHO classification)
2 Clinical diagnosis shows infiltration of the testis or central nervous system (brain, spinal cord, spinal cavity) (cerebrospinal fluid examination and brain MRI are not required).
3 If you have poorly controlled hepatic dysfunction, renal dysfunction, cardiac dysfunction, pulmonary dysfunction, diabetes, or hypertension.
4 Interstitial pneumonia or pulmonary fibrosis (both cases that can be determined on a plain chest X-ray cannot be registered. Mild cases that can only be detected on chest CT are not excluded).
5 Have tubercular disease, herpes simplex keratitis, systemic mycosis, or other active infection.
6 Have a history of acute myocardial infarction, deep vein thrombosis, or pulmonary embolism within six months.
7 Active and advanced-stage multiple cancers (simultaneous multiple cancers and metachronous multiple cancers with a disease-free period of less than 5 years). The lesion is not included in active double cancer).
8 HBs antigen positive, HCV antibody positive, or HIV antibody positive (patients who are HBs antibody or HBc antibody positive are not excluded. Patients are excluded if HBV-DNA is detected. HIV antibody test is not required).
9 There is a history of severe drug hypersensitivity.
10 The person cannot consent due to dementia, etc.
11 In addition, it is determined that it is inappropriate for the facility-responsible physician or study sub-study physician to participate in this study.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St.Marry Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
sa-yamasaki@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St.Marry Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
Homepage URL
sa-yamasaki@st-mary-med.or.jp
Sponsor or person
Institute
St.Marry Hospital
Institute
Department
Personal name
SATOSHI YAMASAKI
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marry Hospital
Address
422 Tufukuhonmachi, Kurume, Fukuoka
Tel
0942353322
sa-yamasaki@st-mary-med.or.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
社会医療法人 雪の聖母会 聖マリア病院(福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 10 | Month | 31 | Day |
Other
Other related information
To enhance patient enrollment, this interventional trial has transitioned to a multi-institutional collaborative study.
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063864
