Rituximab in Pretreated Elderly or Unfit B-CLL Patients

This study is currently recruiting participants.
Verified April 2012 by Vilnius University
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Med. Laimonas Griskevicius, Vilnius University
ClinicalTrials.gov Identifier:
NCT01576588
First received: March 9, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia
Drug: Rituximab
Drug: Glucocorticoid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Vilnius University:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 3 months +/- 2 weeks after the last treatment cycle. ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Molecular Remission), nPR and PR


Secondary Outcome Measures:
  • Progression Free and Overall Survival. [ Time Frame: Approximately 21 month. ] [ Designated as safety issue: No ]
    PFS will be defined as the interval from entry into the study to disease progression or death. OS will be defined as the interval from entry into the study to death.

  • Safety [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]
    Adverse events NCI CTCAE, version 4.0.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
    Other Name: MabThera
    Drug: Glucocorticoid
    Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 and should precede the Rituximab infusion.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576588

Contacts
Contact: Laimonas Griskevicius, MD +37052365029 laimonas.griskevicius@santa.lt
Contact: Tadas Zvirblis +37060422106 tadas.zvirblis@santa.lt

Locations
Lithuania
Vilnius University Hospital Santariskiu Clinics Recruiting
Vilnius, Lithuania, 08661
Contact: Laimonas Griskevicius, MD    +37052365029    laimonas.griskevicius@santa.lt   
Contact: Tadas Zvirblis    +37060422106    tadas.zvirblis@santa.lt   
Sub-Investigator: Regina Pileckyte, MD         
Sub-Investigator: Indre Klimiene, MD         
Sponsors and Collaborators
Prof. Dr. Med. Laimonas Griskevicius
Investigators
Principal Investigator: Laimonas Griskevicius, MD Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santariskiu Clinics
  More Information

Publications:
Responsible Party: Prof. Dr. Med. Laimonas Griskevicius, Principal Investigator, Vilnius University
ClinicalTrials.gov Identifier: NCT01576588     History of Changes
Other Study ID Numbers: LT-CLL-2s
Study First Received: March 9, 2012
Last Updated: April 11, 2012
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Vilnius University:
Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Glucocorticoids
Methylprednisolone
Rituximab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014