Clinical trial NCT03372837: Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
Official title: A Multicenter, Open-label Phase III Study of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL
Keywords: Diffuse large B-cell lymphoma, rituximab, SyB L-0501, combination therapy
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with recurrent/relapsed diffuse large B-cell lymphoma.

Detailed description: Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on Day 2 and Day 3 in combination with rituximab at 375 mg/m\^2 on Day 1 of each 21-day cycle in patients with recurrent/relapsed diffuse large B-cell lymphoma.

Eligibility criteria: Inclusion criteria Patients who satisfy all of the conditions listed below.

1. Patients with histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) except for transformed lymphoma on the basis of World Health Organization (WHO) histological classification (4th ed., 2008).
2. Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells.
3. Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy.
4. Patients with measurable lesions \>1.5 cm in major axes.
5. Patients who are expected to survive for at least 3 months.
6. Patients aged 20 or above at the time informed consent is obtained.
7. Patient with Performance Status (P.S.) 0-1.
8. Patients with adequately maintained organ function.

Exclusion Criteria The study subject should be excluded if any one of the following condition exists.

1. Patients who have been without treatment for less than 3 weeks after prior treatment.
2. Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
3. Patients who received adequate prior treatments and did not respond to any of them.
4. Patient who received prior chemotherapy 3 regimens or more.
5. Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
6. Patient with serious active infection.
7. Patient with serious complication.
8. Patient with complication or medical history of serious cardiac disease.
9. Patient with serious gastrointestinal symptoms.
10. Patient with malignant pleural effusion, pericardial effusion, or ascites retention.
11. Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody.
12. Patient with serious bleeding tendency.
13. Patient with a fever of 38.0°C or higher.
14. Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema.
15. Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ.
16. Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia.
17. Patient who received bendamustin hydrochloride in the past.
18. Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study.

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to 30 weeks
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: up to 30 weeks
measure: Progression Free Survival (PFS)
timeFrame: up to 30 weeks
measure: Duration of Response (DOR)
timeFrame: up to 30 weeks
measure: Overall Survival (OS)
timeFrame: up to 30 weeks.
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Toyoake
country: Japan
facility: Research Site
state: Aichi
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Shibukawa
country: Japan
facility: Research Site
state: Gunma
city: Ōta
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Mibu
country: Japan
facility: Research Site
state: Tochigi
city: Shimotsuke
country: Japan
facility: Research Site
state: Tochigi
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Akita
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
References:
citation: Murayama K, Kiguchi T, Izutsu K, Kameoka Y, Hidaka M, Kato H, Rai S, Kuroda J, Ishizawa K, Ichikawa S, Ando K, Ogura M, Fukushima K, Terui Y. Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma. Ann Hematol. 2022 May;101(5):979-989. doi: 10.1007/s00277-022-04801-2. Epub 2022 Mar 4.