Back to resultsA 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
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Newly diagnosed chronic lymphocytic leukemia
- Age≥ 70 years
- Satisfy the one of indications for starting treatment guideline
- Evidence of progressive marrow failure (anemia, thrombocytopenia)
- AIHA, thrombocytopenia refractory to steroids
- Massive (>6cm, LCM) or symptomatic splenomegaly
- Massive nodes (>10 cm) or symptomatic
- Progressive lymphocytosis
- 50% increase over 2 months or LDT < 6 months
- 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:
- Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
- Hairy cell leukemia or prolymphocytic leukemia
- Uncontrolled infection
- Therapy history with combined chemotherapy or biologic therapy prior to registration
- History of thromboembolic episodes ≤ 3 months prior to registration
- Active hepatitis B or C with uncontrolled disease
- Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
- Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
- Concurrent participation in another therapeutic clinical trial.
Sites / Locations
- Chonnam National University Hwasun HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GC chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall response rate
iwCLL criteria
Secondary Outcome Measures
Complete remission rate
No evidence of disease at the time of tumor assessment by NGS method
Progression free survival
the time from first dose to documented disease progression
Overall survival
the time from first dose to death from any cause
Full Information
NCT ID
NCT04059081
First Posted
August 15, 2019
Last Updated
August 15, 2019
Sponsor
Deok-Hwan Yang
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT04059081
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 8, 2022 (Anticipated)
Study Completion Date
July 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deok-Hwan Yang
Collaborators
Roche Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GC chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
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 Measure Information:
Title
Overall response rate
Description
iwCLL criteria
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Complete remission rate
Description
No evidence of disease at the time of tumor assessment by NGS method
Time Frame
3 years
Title
Progression free survival
Description
the time from first dose to documented disease progression
Time Frame
3 years
Title
Overall survival
Description
the time from first dose to death from any cause
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
Newly diagnosed chronic lymphocytic leukemia
Age≥ 70 years
Satisfy the one of indications for starting treatment guideline
Evidence of progressive marrow failure (anemia, thrombocytopenia)
AIHA, thrombocytopenia refractory to steroids
Massive (>6cm, LCM) or symptomatic splenomegaly
Massive nodes (>10 cm) or symptomatic
Progressive lymphocytosis
50% increase over 2 months or LDT < 6 months
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:
Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
Hairy cell leukemia or prolymphocytic leukemia
Uncontrolled infection
Therapy history with combined chemotherapy or biologic therapy prior to registration
History of thromboembolic episodes ≤ 3 months prior to registration
Active hepatitis B or C with uncontrolled disease
Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
Concurrent participation in another therapeutic clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deok-Hwan Yang, M.D., Ph.D.
Email
drydh1685@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Young-il Koh, M.D., Ph.D.
Email
snuhgo01@gmail.net
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So-Young Lee, Nurse
Phone
82-61-379-7628
Email
kaosin@naver.com
First Name & Middle Initial & Last Name & Degree
Deok-Hwan Yang, M.D.,Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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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