Phase 2
N=70
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
Low-grade B Cell Non-Hodgkin's Lymphoma · Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
Bottom Line
View on ClinicalTrials.gov: NCT01718691 ↗Enrolled (actual)
70
Serious AEs
13.0%
Results posted
Apr 2016
Primary outcome: Primary: Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) — 67.8; 70.0; 68.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SyB L-0501 (Drug); rituximab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- SymBio Pharmaceuticals
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) |
67.8; 70.0; 68.1 | — |
| SECONDARY Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) |
96.6; 90.0; 95.7 | — |
| SECONDARY Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) |
64.4; 80.0; 66.7 | — |
| SECONDARY Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) |
96.6; 90.0; 95.7 | — |
| SECONDARY Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979) |
22.0; 40.0; 24.6 | — |
| SECONDARY Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" |
86.4; 90.0; 87.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
NA; NA; NA | — |
| SECONDARY Duration of Response (DOR) |
NA; NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA | — |
| SECONDARY Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event |
69; 69; 9; 0; 0 | — |
| SECONDARY Laboratory Test Abnormalities (Biochemical Tests) |
3; 3; 1; 1; 1; 2 | — |
| SECONDARY Laboratory Test Abnormalities (Hematology Tests) |
45; 12; 25; 34; 6; 63 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
- Patients expected to live for at least 3 months
- Patients aged between 20 and 79 years (at the time of registration)
- Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2
- 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
- Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site
- Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (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%
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01718691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.