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

Phase 2

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Obinutuzumab

• Registration Number: NCT04059081
• Lead Sponsor: Deok-Hwan Yang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-09
• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Last Update Submitted: 2019-08-15
• Study First Posted: 2019-08-16
• Last Update Posted: 2019-08-16
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

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
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  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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GC chemotherapy	Obinutuzumab	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.

Primary Outcome Measures

Name	Time	Method
Overall response rate	3 years	iwCLL criteria

Secondary Outcome Measures

Name	Time	Method
Complete remission rate	3 years	No evidence of disease at the time of tumor assessment by NGS method
Overall survival	3 years	the time from first dose to death from any cause
Progression free survival	3 years	the time from first dose to documented disease progression

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Jeollanam-do, Korea, Republic of