Rituximab in Pretreated Elderly or Unfit B-CLL Patients

December 17, 2019 updated by: Prof. Dr. Med. Laimonas Griskevicius

Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor performance status or >/=65 years of age with any performance status.

Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and Rituximab every 21 day.

Study Duration: The study period for each subject is expected to be 21 months. Subjects will receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of treatment is expected to be 6 months. Subjects will complete scheduled visits not later than Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.

Study Type

Interventional

Enrollment (Actual)

25

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 Locations

  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University hospital Santaros klinikos

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The diagnosis of CD20 positive chronic B lymphocytic leukemia (BCLL) confirmed by biopsy or flow-cytometry.
  • Previously treated patients with stage Rai I-IV and progressive disease (according to IWCLL 2008 guidelines).

Active B-CLL is defined by at least one of the following:

At least one of the disease related symptoms:

  • Constitutional symptoms:
  • Weight loss >10% within the previous 6 months;
  • Fatigue (e.g., WHO performance status >/=2);
  • Fever >/=38C >/=2 weeks without evidence of infection;
  • Night sweats for more than 1 month without evidence of infection.
  • Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia
  • Autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid therapy.
  • Massive (i.e., >/=6 cm bellow left costal margin) or progressive or symptomatic splenomegaly.
  • Massive lymphadenopathy or conglomerates (i.e., >/=10 cm in largest diameter) or progressive or symptomatic lymphadenopathy.
  • Progressive lymphocytosis with an increase >50% over a 2-month period or an anticipated doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x10^9/L LDT should not be used as a single parameter to define treatment indication. Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
  • Either of the following:
  • 18 years of age or older with impaired performance status (CIRS > 6) and /or
  • 65 years of age or older with any performance status.
  • Signed informed consent form.

Exclusion Criteria:

  • Intolerance to exogenous protein or known severe reaction to the administration of Rituximab.
  • Active infection.
  • Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1.
  • TBC or fungal infection within the past 6 months even if adequately controlled by treatment.
  • Severe organ deficiency preventing the participation in the study.
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
  • Active peptic ulcer.
  • Inadequately controlled diabetes mellitus.
  • Suspected or confirmed B-CLL CNS disease.
  • Known to be HIV positive.
  • Difficult to control, uncooperative patients.
  • Allergic disorders in need of chronic glucocorticoid therapy.
  • Other oncological diseases requiring active treatment (except hormonal therapy).
  • Pregnancy and breastfeeding.
  • Patients of reproductive potential who are not using effective methods of contraception.

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: R-HDMP

Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).

Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Drug: Rituximab
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Other Names:
  • MabThera
Drug: Glucocorticoid
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 3 months +/- 2 weeks after the last treatment cycle.
Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).
3 months +/- 2 weeks after the last treatment cycle.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: up to 12 months
Progression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.
up to 12 months
Number of Participants With Adverse Events
Time Frame: 6 months.
Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.
6 months.
Overall Survival
Time Frame: from date of randomization until the date of death from any cause, assessed up to 100 months
Overall survival (OS) will be defined as the interval from date of randomization until the date of death from any cause, assessed up to 100 months.
from date of randomization until the date of death from any cause, assessed up to 100 months

Collaborators and Investigators

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

Sponsor

Prof. Dr. Med. Laimonas Griskevicius

Investigators

  • Principal Investigator: Laimonas Griskevicius, MD, Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos

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)

October 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-CLL-2s

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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