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A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT03003039
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Nanjing Yoko Biomedical Co., Ltd.

Brief Summary:
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.

Condition or disease Intervention/treatment Phase
B-Cell Lymphoma Biological: GB241 Biological: Rituximab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: GB241
GB241:375 mg/m2, iv, one infusion
Biological: GB241
Active Comparator: Rituximab
Rituximab: 375 mg/m2, iv, one infusion
Biological: Rituximab



Primary Outcome Measures :
  1. Area under the curve (AUC) for GB241 and rituximab concentrations [ Time Frame: 85 days ]

Secondary Outcome Measures :
  1. AUC for GB241 and rituximab concentrations [ Time Frame: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks ]
  2. Maximum observed concentration of the GB241 and rituximab [ Time Frame: 85 days ]
  3. Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms [ Time Frame: 85 days ]
  4. Comparison of AEs between the two study arms [ Time Frame: 85 days ]
  5. Comparison of the incidence rate of HACA(host anti-chimeric antibody) between the two study arms [ Time Frame: 85 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having histologically confirmed NHL expressing CD20 antigen
  • having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
  • signed an informed consent form which was approved by the institutional review board of the respective medical center
  • aged from 18 to 75 years
  • ECOG performance status of 0 to 1
  • expected survival of at least ≥ 3 months

Exclusion Criteria:

  • had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
  • having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
  • participating in other clinical trial within 30 days before enrolment
  • with serious hematologic dysfunction (white blood cell count of <3.0×103/uL; absolute neutrophil count of <1.5×103/ uL; platelet count of < 75×103/uL; hemoglobin level of < 8.0 g/dL); hepatic dysfunction (total bilirubin level of > 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) > 1.5 × ULN (unless on therapeutic coagulation)
  • had received live vaccine within 4 weeks prior to study entry
  • with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease
  • seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated
  • recent major surgery (within 28 days prior to study entry )
  • with a history of allergic reaction or protein product allergy including murine proteins
  • pregnant or lactating or not accepted birth control methods including male patients
  • patients considered unsuitable by PI
  • previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer
  • active opportunistic infections and other serious non neoplastic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003039


Contacts
Contact: xu tie, master 86-18036618680 15252822887@163.com

Locations
China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100076
Contact: shi yuankai, doctor    8610-87788293    shaojing@yoko-bio.com   
Sponsors and Collaborators
Nanjing Yoko Biomedical Co., Ltd.

Responsible Party: Nanjing Yoko Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03003039     History of Changes
Other Study ID Numbers: GB241NHL1
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016

Keywords provided by Nanjing Yoko Biomedical Co., Ltd.:
GB241
Rituximab
B-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents