Chronic Lymphocytic Leukemia
Conditions
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.
Interventions
DRUGObinutuzumab
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.
Sponsors
Roche Pharma AG
Deok-Hwan Yang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 3 years | iwCLL criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate | 3 years | No evidence of disease at the time of tumor assessment by NGS method |
| Progression free survival | 3 years | the time from first dose to documented disease progression |
| Overall survival | 3 years | the time from first dose to death from any cause |
Countries
South Korea
Contacts
Primary ContactDeok-Hwan Yang, M.D., Ph.D.
Backup ContactYoung-il Koh, M.D., Ph.D.
Outcome results
None listed