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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

Sponsor
Deok-Hwan Yang (Other)
Overall Status
Unknown status
CT.gov ID
NCT04059081
Collaborator
Roche Pharma AG (Industry)
31
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 9, 2019
Anticipated Primary Completion Date :
Jul 8, 2022
Anticipated Study Completion Date :
Jul 8, 2022

Arms and Interventions

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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [3 years]

    iwCLL criteria

Secondary Outcome Measures

  1. Complete remission rate [3 years]

    No evidence of disease at the time of tumor assessment by NGS method

  2. Progression free survival [3 years]

    the time from first dose to documented disease progression

  3. Overall survival [3 years]

    the time from first dose to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  4. Evidence of progressive marrow failure (anemia, thrombocytopenia)

  5. AIHA, thrombocytopenia refractory to steroids

  6. Massive (>6cm, LCM) or symptomatic splenomegaly

  7. Massive nodes (>10 cm) or symptomatic

  8. Progressive lymphocytosis

  9. 50% increase over 2 months or LDT < 6 months

  10. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonnam National University Hwasun Hospital Hwasun Jeollanam-do Korea, Republic of 519-809

Sponsors and Collaborators

  • Deok-Hwan Yang
  • Roche Pharma AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Deok-Hwan Yang, M.D., Ph.D., Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT04059081
Other Study ID Numbers:
  • ML40990
First Posted:
Aug 16, 2019
Last Update Posted:
Aug 16, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Obinutuzumab

Study Results

No Results Posted as of Aug 16, 2019