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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Obinutuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Overall response rate [ Time Frame: 3 years ]iwCLL criteria
- Complete remission rate [ Time Frame: 3 years ]No evidence of disease at the time of tumor assessment by NGS method
- Progression free survival [ Time Frame: 3 years ]the time from first dose to documented disease progression
- Overall survival [ Time Frame: 3 years ]the time from first dose to death from any cause
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
|Contact: Deok-Hwan Yang, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Young-il Koh, M.D., Ph.D.||email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Deok-Hwan Yang, M.D.,Ph.D.|