Clinical trial NCT01118845: Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Official title: A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lymphoma, Large Cell
Diffuse, Mantle Cell Lymphoma, Lymphoma
Follicular Lymphoma
Large B-Cell, Diffuse
Keywords: Non-Hodgkin's lymphoma
Lymphoma, Large B-Cell
Diffuse, Mantle cell lymphoma, Lymphoma
Follicular, Lymphoma
Large B-Cell, Diffuse
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
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 relapsed/refractory 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 day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
* Patients with measurable lesions
* Patients with measurable lesions \>1.5 cm in major axes
* Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
* Patients who are expected to survive for at least 3 months
* Patients aged from 20 to 75 years at the time informed consent is obtained
* Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
* Patients with adequately maintained organ functions
* Patients capable of personally giving voluntary informed consent in writing to participate in the study

Exclusion Criteria:

* Patients who have been without treatment for less than 3 weeks after prior treatment
* Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
* Patients who received adequate prior treatments and did not respond to any of them.
* Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
* Patients with serious, active infections
* Patients with serious complications
* Patients with complications or medical history of serious cardiac disease
* Patients with serious gastrointestinal symptoms
* Patients with malignant pleural effusion, cardiac effusion, or ascites retention
* Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
* Patients with serious bleeding tendencies
* Patients with a fever of 38.0°C or higher
* Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
* 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
* Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
* Patients who received SyB L-0501 in the past
* 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
* Patients who received other investigational products or unapproved medication within 3 months before registration in this study

Primary outcomes:
measure: The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
timeFrame: up to 30 weeks
Secondary outcomes:
measure: The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
timeFrame: up to 30 weeks
measure: Progression Free Survival (PFS)
timeFrame: up to 30 weeks
measure: Number of Subjects With Adverse Event
timeFrame: up to 30 weeks
measure: Number of Adverse Events
timeFrame: up to 30 weeks
measure: Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
timeFrame: up to 30 weeks
measure: Number of Subjects With Grade ≥3 Physical Examination Finding
timeFrame: up to 30 weeks
measure: Concomitant Medication Usage
timeFrame: up to 30 weeks
measure: The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
measure: The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
timeFrame: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Matsuyama
country: Japan
state: Ehime
city: Kurume
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Sapporo
country: Japan
state: Hokkaido
city: Kanazawa
country: Japan
state: Ishikawa
city: Isehara
country: Japan
state: Kanagawa
city: Ninomaru
country: Japan
state: Kumamoto
city: Sendai
country: Japan
state: Miyagi
city: Kita-ku
country: Japan
state: Okayama
city: Kurashiki
country: Japan
state: Okayama
city: Hidaka
country: Japan
state: Saitama
city: Izumo
country: Japan
state: Shimane
city: Chuo-ku
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kyoto
country: Japan
city: Seo-gu
country: Korea, Republic of
state: Busan
city: Jung-gu
country: Korea, Republic of
state: Daegu
city: Goyang-si
country: Korea, Republic of
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
state: Jeonnam
city: Gangnam-gu
country: Korea, Republic of
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
state: Seoul
city: Songpa-gu
country: Korea, Republic of
state: Seoul
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, MD, Ph D
role: STUDY_CHAIR
References: