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Chronic Lymphocytic LeukemiaPhase 2NCT02042911

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

A Phase 2 study testing SyB L-0501 in people with Chronic Lymphocytic Leukemia, run by SymBio Pharmaceuticals at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
SyB L-0501
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesJapan
Study dates
Jan 2013to Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Massive nodes (≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period, or lymphocyte doubling time of less than 6 months
  • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
  • B symptoms Weight loss > 10% within the previous 6 months Fevers of greater than 38.0° C for 2 or more weeks without other evidence of infection Night sweats
  • Patients with 2 or less regimens of previous chemotherapy including antibody therapy. Corticosteroid monotherapy is not counted.
  • Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
  • Neutrophil count: ≥ 1,000 /mm3
  • Aspartate aminotransferase(AST) Glutamic oxaloacetic transaminase(GOT): ≤ 3.0 times the upper limit of normal range at each site
  • Alanine aminotransferase (ALT) Glutamic pyruvic transaminase(GPT): ≤ 3.0 times the upper limit of normal range at each site
  • Total bilirubin: ≤ 1.5 times the upper limit of normal range at each site
  • Serum creatinine: ≤ 1.5 times the upper limit of normal range at each site
  • Partial pressure of O2 (PaO2): ≥ 65 mmHg
  • No abnormalities which require treatment are detected on ECG
  • Left ventricular ejection fraction (LVEF) (echocardiography): ≥ 55%

Who cannot join

  • 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
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  • 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
  • accumulation of pleural effusion, pericardial effusion, or peritoneal effusion
  • uncontrollable serious gastrointestinal disease, endocrine disorder, or mental illness
  • Patients who received SyB L-0501 in the past
  • Patients with allergies to mannitol
  • Patients who need cytokine preparations such as erythropoietin or granulocyte colony stimulating factor (G-CSF) or blood transfusions at registration for this study
  • Patients positive for HIV antibody or Hepatitis C virus (HCV) antibody
  • Patients positive for Hepatitis B surface (HBs) antigen. Patients with negative results will also be checked for Hepatitis B core (HBc) antibody and HBs antibody. If either of the test results is positive, measure Hepatitis B virus (HBV)-DNA and exclude the patients with results above sensitivity
  • Patients with clinical symptom of cytomegalovirus (CMV) infection, except asymptomatic patients with CMV positive
  • Patients who are pregnant, who may possibly be pregnant, or lactating
  • Patients who do not agree to practice contraception. Male: During investigational product administration and until 6 months after final administration Female: During investigational product administration and until 4 months after final administration
  • Patients with drug addiction, narcotics addiction, and/or alcohol dependency
  • Patients otherwise judged by the investigator or sub-investigator to be unsuitable for inclusion in this study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Research Site

    Fukuyama, Hiroshima

  • Research Site

    Isehara, Kanagawa

  • Research Site

    Izumo, Shimane

  • Research Site

    Kagoshima, Kagoshima-ken

  • Research Site

    Minato-ku, Tokyo

  • Research Site

    Nagoya, Aichi-ken

Other trials in Japan

About this study

Official title: A Multicenter, Open-label Phase II Study of SyB L-0501 in Patients With Chronic Lymphocytic Lymphoma

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.

Being tested
SyB L-0501
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SyB L-0501Drug

    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.

Study groups in NCT02042911
Study groupRoleWhat they receive
SyB L-0501ExperimentalNot described
Receives: Drug: SyB L-0501

What is being measured

The primary outcome is the main question the study is designed to answer.

  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
    1. less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules).
    2. 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.

    Measured: Up to 30 months

Secondary outcomes (8)

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

    The criteria for nPR and PR based on IWCLL guideline are shown below.

    nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination.

    PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks.

    Group A;

    1. 50% or greater reduction in lymphocyte count in peripheral blood from baseline
    2. 50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node
    3. A decrease in the size of the liver and/or spleen by 50% more
    4. A decrease in marrow infiltration or lymphoid nodules by 50% more Group B;
    5. Neutrophil count >1.5×10^9/L or 50% improvement from baseline 2) Platelet count >100×10^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions

    Measured: Up to 30 months

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

    Measured: Up to 30 months

  3. Progression-free Survival (PFS)

    The period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.

    Measured: Up to 30 months

  4. Duration of Remission

    The period from the day of CR or PR confirmation to recurrence/relapse.

    Measured: Up to 30 months

  5. Overall Survival (OS)

    The period from the date of patient registration to the date of death.

    Measured: Up to 30 months

  6. Adverse Events

    All undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.

    Measured: Up to 30 months

  7. Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More

    Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to adverse event

    Measured: Up to 30 months

  8. Number of Subjects With Clinically Significant Physical Examination Values

    Number of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02042911
Sponsor's protocol ID
2012003
Status last verified
Dec 2016
First submitted
17 Dec 2013
Last updated
1 Feb 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SyB L-0501 in people with Chronic Lymphocytic Leukemia, run by SymBio Pharmaceuticals at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02042911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.

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