Rituximab in Pretreated Elderly or Unfit B-CLL Patients
NCT ID: NCT01576588
Last Updated: 2019-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2011-10-31
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Rituximab
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rituximab
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prof. Dr. Med. Laimonas Griskevicius
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Med. Laimonas Griskevicius
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laimonas Griskevicius, MD
Role: PRINCIPAL_INVESTIGATOR
Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pileckyte R, Jurgutis M, Valceckiene V, Stoskus M, Gineikiene E, Sejoniene J, Degulys A, Zvirblis T, Griskevicius L. Dose-dense high-dose methylprednisolone and rituximab in the treatment of relapsed or refractory high-risk chronic lymphocytic leukemia. Leuk Lymphoma. 2011 Jun;52(6):1055-65. doi: 10.3109/10428194.2011.562572.
Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23.
Pileckyte R, Valceckiene V, Stoskus M, Matuzeviciene R, Sejoniene J, Zvirblis T, Griskevicius L. Dose Intensive Rituximab and High-Dose Methylprednisolone in Elderly or Unfit Patients with Relapsed Chronic Lymphocytic Leukemia. Medicina (Kaunas). 2019 Oct 29;55(11):719. doi: 10.3390/medicina55110719.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LT-CLL-2s
Identifier Type: -
Identifier Source: org_study_id