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

Deok-Hwan Yang

Status and phase: Unknown; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Obinutuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04059081

ML40990

Details and patient eligibility

About

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.

Enrollment: 31 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

GC chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Obinutuzumab