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

August 15, 2019 updated by: Deok-Hwan Yang
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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 519-809
        • Recruiting
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 3 years
iwCLL criteria
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Anticipated)

July 8, 2022

Study Completion (Anticipated)

July 8, 2022

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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