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A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment

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ClinicalTrials.gov Identifier: NCT04059081
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Deok-Hwan Yang, Chonnam National University Hospital

Brief Summary:
This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Obinutuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 8, 2022
Estimated Study Completion Date : July 8, 2022


Arm Intervention/treatment
Experimental: GC chemotherapy

Before administration of GC chemotherapy, all patients must undergo pretreatment bone marrow biopsy. The pretreatment BM biopsy must include at least 1 long core biopsy samples and 10 cc of aspirate.

Obinutuzumab 1000mg fixed dose will be administered intravenously (Day 1,8,15 for cycle 1 and D1 for subsequent cycles). Chlorambucil 0.5mg/kg will be administered orally (D1,15 for all cycles).

28 days are considered as one cycle, and cycles will be repeated every 4-weeks for a total of 6 cycles.

Drug: Obinutuzumab

Obinutuzumab is provided as single-use vials for intravenous administration only. Obinutuzumab 1000mg fixed dose will be administered Chlorambucil would be provided as oral tablet with dose of 0.5mg/kg

Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, until 6 cycles.





Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 3 years ]
    iwCLL criteria


Secondary Outcome Measures :
  1. Complete remission rate [ Time Frame: 3 years ]
    No evidence of disease at the time of tumor assessment by NGS method

  2. Progression free survival [ Time Frame: 3 years ]
    the time from first dose to documented disease progression

  3. Overall survival [ Time Frame: 3 years ]
    the time from first dose to death from any cause



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

    1. Newly diagnosed chronic lymphocytic leukemia
    2. Age≥ 70 years
    3. Satisfy the one of indications for starting treatment guideline
    1. Evidence of progressive marrow failure (anemia, thrombocytopenia)
    2. AIHA, thrombocytopenia refractory to steroids
    3. Massive (>6cm, LCM) or symptomatic splenomegaly
    4. Massive nodes (>10 cm) or symptomatic
    5. Progressive lymphocytosis
    6. 50% increase over 2 months or LDT < 6 months
    7. Constitutional Symptoms : weight loss > 10% in 6 months, significant fatigue, fever >38 over 2 weeks, night sweat > 1month 4. ECOG performance status 0-2 5. Total bilirubin ≤ 1.5 x ULN (upper limit of normal) 6. Aspartate aminotransferase (AST) ≤ 5 x ULN, (ALT) ≤ 5 x ULN 7. Creatinine ≤ 3.0 x ULN 8. Provide informed consent Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Exclusion Criteria:

  1. Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
  2. Hairy cell leukemia or prolymphocytic leukemia
  3. Uncontrolled infection
  4. Therapy history with combined chemotherapy or biologic therapy prior to registration
  5. History of thromboembolic episodes ≤ 3 months prior to registration
  6. Active hepatitis B or C with uncontrolled disease
  7. Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
  8. Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
  9. Concurrent participation in another therapeutic clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059081


Contacts
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Contact: Deok-Hwan Yang, M.D., Ph.D. drydh1685@hotmail.com
Contact: Young-il Koh, M.D., Ph.D. snuhgo01@gmail.net

Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanam-do, Korea, Republic of, 519-809
Contact: So-Young Lee, Nurse    82-61-379-7628    kaosin@naver.com   
Principal Investigator: Deok-Hwan Yang, M.D.,Ph.D.         
Sponsors and Collaborators
Deok-Hwan Yang
Roche Pharma AG

Publications:

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Responsible Party: Deok-Hwan Yang, M.D., Ph.D., Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT04059081     History of Changes
Other Study ID Numbers: ML40990
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Obinutuzumab
Chlorambucil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action