Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01718691
First received: October 29, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.


Condition Intervention Phase
Low-grade B Cell Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
Drug: SyB L-0501
Drug: rituximab
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by SymBio Pharmaceuticals:

Primary Outcome Measures:
  • Complete Remission Rate (CR + CRu) based on "International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)" [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy [Overall response rate (antitumor effect: PR or better) based on "International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)"] [ Designated as safety issue: No ]
  • Efficacy [Complete remission rate (CR) and overall response rate based on "Revised Response Criteria for Malignant Lymphoma (2007)"] [ Designated as safety issue: No ]
  • Efficacy [Complete remission rate and overall response rate based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"] [ Designated as safety issue: No ]
  • Efficacy [Progression-Free Survival (PFS)] [ Designated as safety issue: No ]
  • Efficacy [Duration of Response (DOR)] [ Designated as safety issue: No ]
  • Efficacy [Overall Survival (OS)] [ Designated as safety issue: No ]
  • Safety (Adverse events) [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (blood test)] [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (biochemical test)] [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (Urine test)] [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (Bone marrow test)] [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (Viral marker)] [ Designated as safety issue: Yes ]
  • Safety [Change in laboratory values (Immunological test)] [ Designated as safety issue: Yes ]

Arms Assigned Interventions
Experimental: SyB L-0501+rituximab Drug: SyB L-0501
A dose of 90 mg/m2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
Drug: rituximab
A dose of 375 mg/m2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are histopathologically confirmed to have the following CD20 positive low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before the registration WHO Classification of Tumors (fourth edition):

    • Small lymphocytic lymphoma
    • Splenic marginal zone B-cell lymphoma
    • Lymphoplasmacytic lymphoma
    • Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)
    • Nodal marginal zone B-cell lymphoma
    • Follicular lymphoma (Grade 1, 2, 3a)
    • Mantle cell lymphoma
  2. Patients with a measurable lesion ( > 1.5 cm in major axis on CT)
  3. Patients without a medical history
  4. Patients with at least 1 of the following clinical symptoms or signs (excluding mantle cell lymphoma):

    • Bulky disease measuring > 7 cm in major axis on CT (excluding spleen)
    • B symptoms

      1. Fever exceeding 38.0ºC of unknown cause
      2. Night sweats
      3. Weight decrease exceeding 10% within 6 months before patient registration
    • Elevated serum LDH or beta 2 microglobulin
    • Three or more regional lymph nodes of > 3 cm in major axis on CT
    • Symptomatic splenomegaly
    • Intracranial pressure
    • Pleural effusion/ascites retention
  5. Patients expected to live for at least 3 months
  6. Patients aged between 20 and 79 years (at the time of registration)
  7. Patients whose ECOG performance status (P.S.) is 0~2
  8. Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys)

    • Neutrophil count: not less than 1,500 /mm3
    • Platelet count: not less than 75,000 /mm3
    • AST (GOT): not more than 3 times the standard upper limit for the site
    • ALT (GPT): not more than 3 times the standard upper limit for the site
    • Total bilirubin: not more than 1.5 times the standard upper limit for the site
    • Serum creatinine: not more than 1.5 times the standard upper limit for the site
    • Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg
    • Electrocardiogram shows no abnormal findings that require treatment
    • Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55%
  9. Patients whose informed consent has been obtained in person

Exclusion Criteria:

Patients who fall under any one of the following criteria are to be excluded

  1. Patients whose transformation has been confirmed histopathologically
  2. Mantle cell lymphoma patients aged 65 years or younger
  3. Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test
  4. Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection)
  5. Patients with serious complications (such as hepatic or renal failure)
  6. Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment
  7. Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea).
  8. Patients who are positive for HBs antigen, HCV antibody or HIV antibody (if HBs or HBc positive, patients whose HBV-DNA test results indicate positive)
  9. Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)]
  10. Patients having or suspected of having symptoms indicative of CNS involvement
  11. Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history.
  12. Patients with active multiple primary cancer
  13. Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past
  14. Patients with complications or medical history of autoimmune haemolytic anaemia
  15. Patients who were administered investigative or unapproved drugs within 3 months before patient registration.
  16. Patients with addiction to drugs or narcotics, or alcoholism
  17. Patients who have previously received hematopoietic stem cell transplantation
  18. Patients who are or may be pregnant, lactating patients
  19. Patients, whether male or female, who do not agree to use contraception
  20. Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718691

Locations
Japan
Research site
Nagoya, Aichi, Japan
Research site
Kashiwa, Chiba, Japan
Research site
Sapporo, Hokkaido, Japan
Research site
Isehara, Kanagawa, Japan
Research site
Sendai, Miyagi, Japan
Research site
Moriguchi, Osaka, Japan
Research site
Izumo, Shimane, Japan
Research site
Hamamatsu, Shizuoka, Japan
Research site
Utsunomiya, Tochigi, Japan
Research site
Fukuoka, Japan
Research site
Kagoshima, Japan
Research site
Kyoto, Japan
Research site
Nagasaki, Japan
Research site
Tokyo, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
  More Information

No publications provided

Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01718691     History of Changes
Other Study ID Numbers: 2011002
Study First Received: October 29, 2012
Last Updated: December 17, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on September 16, 2014