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

NCT01718691 | Completed Phase 2 Results

• 1 other identifier: 2011002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Low-grade B Cell Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)

  The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following * Disappearance of all detectable disease * LN\* \> 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following * LN \>1.5 cm; SPD\*\* decrease \>75% * indeterminate bone marrow * LN: lymph nodes or nodal masses \*\* SPD: sum of the products of the greatest diameters

  Up to 30 weeks

Secondary Outcomes (11)

• Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)

  Up to 30 weeks

• Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)

  Up to 30 weeks

• Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)

  Up to 30 weeks

• Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)

  Up to 30 weeks

• Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"

  Up to 30 weeks

Study Arms (1)

SyB L-0501＋rituximab

EXPERIMENTAL

Drug: SyB L-0501; Drug: rituximab

Interventions

SyB L-0501 DRUG

A dose of 90 mg/m\^2/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.

SyB L-0501＋rituximab

rituximab DRUG

A dose of 375 mg/m\^2 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.

SyB L-0501＋rituximab

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are histopathologically confirmed to have the following cluster of differentiation 20 (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
• Patients with a measurable lesion ( \> 1.5 cm in major axis on CT)
• Patients without a medical history
• 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
• Fever exceeding 38.0ºC of unknown cause
• Night sweats

You may not qualify if:

• Patients who fall under any one of the following criteria are to be excluded
• Patients whose transformation has been confirmed histopathologically
• Mantle cell lymphoma patients aged 65 years or younger
• 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
• Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection)
• Patients with serious complications (such as hepatic or renal failure)
• 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
• Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea)
• Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody \[if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive\]
• Patients with serious bleeding tendencies \[such as disseminated intravascular coagulation (DIC)\]
• Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement
• Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history.
• Patients with active multiple primary cancer
• Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past
• Patients with complications or medical history of autoimmune haemolytic anaemia

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (14)

Research site

Nagoya, Aichi-ken, Japan

Location

Research site

Kashiwa, Chiba, Japan

Location

Research site

Fukuoka, Fukuoka, Japan

Location

Research site

Sapporo, Hokkaido, Japan

Location

Research site

Kagoshima, Kagoshima-ken, Japan

Location

Research site

Isehara, Kanagawa, Japan

Location

Research site

Kyoto, Kyoto, Japan

Location

Research site

Sendai, Miyagi, Japan

Location

Research site

Nagasaki, Nagasaki, Japan

Location

Research site

Moriguchi, Osaka, Japan

Location

Research site

Izumo, Shimane, Japan

Location

Research site

Hamamatsu, Shizuoka, Japan

Location

Research site

Utsunomiya, Tochigi, Japan

Location

Research site

Tokyo, Tokyo, Japan

Location

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Toshihiko Nagase
• Organization: SymBio Pharmaceuticals

+81-3-5472-1125

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 27, 2016
• Results First Posted: April 27, 2016

Record last verified: 2016-03

Locations

JP (14)