Trials / Unknown
UnknownNCT04059081
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Deok-Hwan Yang · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-07-09
- Primary completion
- 2022-07-08
- Completion
- 2022-07-08
- First posted
- 2019-08-16
- Last updated
- 2019-08-16
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04059081. Inclusion in this directory is not an endorsement.