Status:
UNKNOWN
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
Lead Sponsor:
Deok-Hwan Yang
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 al...
Eligibility Criteria
Inclusion
- 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
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- 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
- 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.
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04059081
Start Date
July 9 2019
End Date
July 8 2022
Last Update
August 16 2019
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 519-809