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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2022-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GC chemotherapy

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No