Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia

NCT02042911 | Completed Phase 2 Results

• 1 other identifier: 2012003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline

  The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR). CR: Assessment should be made at least 8 weeks after completion of administration. 1. Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter) 2. No hepatomegaly or splenomegaly 3. Absence of B symptoms 4. Meet the following laboratory test values; * lymphocyte count in peripheral blood: \<4.0×10\^9/L * neutrophil count: \>1.5×10\^9/L * platelet count: 100×10\^9/L * hemoglobin: 11.0 g/dL without transfusions 5. less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules). 6. No new lesion emergence CRi: Fulfills all of the following criteria * Delayed anemia, thrombocytopenia, or neutropenia is observed. * Fulfills all CR criteria other than 4). * Delayed symptoms are all judged to be caused by drug.

  Up to 30 months

Secondary Outcomes (8)

• National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline

  Up to 30 months

• Complete Remission Rate (CR+CRi) Based on IWCLL Guideline

  Up to 30 months

• Progression-free Survival (PFS)

  Up to 30 months

• Duration of Remission

  Up to 30 months

• Overall Survival (OS)

  Up to 30 months

Study Arms (1)

SyB L-0501

EXPERIMENTAL

Drug: SyB L-0501

Interventions

SyB L-0501 DRUG

SyB L-0501 is administered at 100 mg/m2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.

SyB L-0501

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting all of the following criteria are to be included in the study:
• Patients aged between 20 and 80 years (at the time of registration)
• Patients who have provided written consent in person for participation in this study
• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
• Patients who are expected to survive for at least 3 months
• Patients who are naive to or not suitable for fludarabine therapy
• Patients who are documented with chronic lymphocytic leukemia on the basis of International Workshop on Chronic Lymphocytic Leukaemia guideline (IWCLL) guideline:
• The presence of ≥ 5000/mm3 monoclonal mature B-lymphocytes in the peripheral blood
• ≤ 55 % atypical lymphocytes, prolymphocyte-like cells, and lymphoblasts with prominent nucleoli
• For monoclonal mature B-lymphocytes, at least one of the B-cell specific differentiation antigens (Cluster of differentiation (CD) 19, CD 20, and CD 23) and CD 5 is positive by flow cytometry
• Patients in Stage C or stage B with active disease based on Binet staging system (at the time of registration)
• Decision to start treatment should be made upon IWCLL guideline criteria.
• Active disease is defined to meet at least one of the following criteria.
• Progression and/or worsening of anemia and/or thrombocytopenia caused by decreased bone marrow function.
• Massive (6 cm below the left costal margin) or progressive or symptomatic splenomegaly

You may not qualify if:

• Patients who fall under any one of the following criteria are to be excluded
• Patients who have been without treatment for less than 4 weeks after prior treatment. For patients treated with antibody therapy or underwent hematopoietic stem cell transplantation, for 3 months after prior treatment
• Patients who enrolled other clinical studies within 4 weeks before registration for this study
• Patients who received allogeneic stem cell transplantation in the past
• Patients with defective p53 (17p-) confirmed by chromosome analysis (Fluorescence in situ hybridization (Fish) method)
• Patients who are clinically diagnosed with Richter's syndrome
• Patients with infiltration to the central nervous system (CNS) or patients with clinical symptoms of suspected infiltration to the CNS
• Patients with multiple primary cancers or patients with a history of other malignant tumors within past 5 years, except for basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or gastrointestinal tract
• Patients with serious bleeding tendencies (e.g., disseminated intravascular coagulation (DIC))
• Patients with, or confirmed in the past to have had, interstitial lung disease or pulmonary fibrosis
• Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia responds to corticosteroid therapy
• Patients with any of the following complications
• serious cardiac disease (e.g., myocardial infarction, ischemic heart disease, or arrhythmia requiring treatment)
• serious, active infections (requiring intravenous administration of antibiotics, antifungal drugs, or antiviral drugs)
• hepatic or renal dysfunction

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (6)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Fukuyama, Hiroshima, Japan

Location

Research Site

Kagoshima, Kagoshima-ken, Japan

Location

Research Site

Isehara, Kanagawa, Japan

Location

Research Site

Izumo, Shimane, Japan

Location

Research Site

Minato-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Toshihiko Nagase
• Organization: SymBio Pharmaceuticals

+81-3-5472-1127

Study Officials

• Toshihiko Nagase

  SymBio Pharmaceuticals

  STUDY DIRECTOR

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: December 17, 2013
• First Posted: January 23, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 1, 2017
• Results First Posted: March 29, 2016

Record last verified: 2016-12

Locations

JP (6)