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| Sponsor: | Vilnius University |
|---|---|
| Information provided by: | Vilnius University |
| ClinicalTrials.gov Identifier: | NCT00558181 |
Purpose
Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.
Study Objectives
Primary:
To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.
Secondary:
To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic B-Lymphocytic Leukemia |
Drug: rituximab, methylprednisolone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: rituximab, methylprednisolone
Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.
|
Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.
Study Objectives
Primary:
To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.
Secondary:
To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.
Patient Population Patients with previously treated symptomatic high risk B-CLL 18 years of age and older.
Study Duration The study period for each subject is expected to be 21 months. Subjects will receive up-to 6 cycles of IV infusion of Methylprednisolone and Rituximab. Maximum duration of treatment is expected to be 9 months. All infusions of study treatment will be administered by medically qualified site staff in an inpatient or outpatient clinic under the supervision of an Investigator. Subjects will complete scheduled visits not later than Study Month 21, after which time 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, except in cases lost to follow up, or if a subject withdraws informed consent.
Study Design Phase II, multicenter, non-randomized, open label study.
Maximum Recruitment Period 2 years
Number of Planned Subjects Approximately 50 patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active B-CLL is defined by at least one of the following:
At least one of the disease related symptoms:
Constitutional symptoms:
1.1. Weight loss more 10 percent within the previous 6 months; 1.2. Fatigue (e. g. WHO performance status 2 or more); 1.3. Fever 38C or more 2 weeks or more without evidence of infection; 1.4. Night sweats without evidence of infection.
Evidence of progressive marrow failure as manifested by:
2.1. anemia (less 110 g/l) and / or 2.2. thrombocytopenia (less 100 x 109/l) within the previous 6 months and / or 2.3. neutropenia (less 1 x 109/l) within the previous 6 months.
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 4. High-risk B-CLL biologically or clinically: 4.1. Biologically high-risk B-CLL is defined by the presence of at least one of the following factors: 4.1.1. 98 percent or more lgVH genes are homologous to the embryonic sequence and / or 4.1.2. 17p del confirmed by FISH or 4.1.3. 11q del confirmed by FISH or 4.1.4. 12 trisomy. 4.2. Clinically high-risk B-CLL is defined by the presence of at least one of the following factors: 4.2.1. Progressive or stable disease while on Fludarabine treatment. 4.2.2. Relapse after Fludarabine treatment within 12 months. 5. Older than 18 years. 6. Signed informed consent form.
Exclusion Criteria:
Contacts and Locations| Lithuania | |
| Klaipeda Seamen's Hospital | |
| Klaipeda, Lithuania, 92288 | |
| Vilnius University Hospital Santariskiu Clinics | |
| Vilnius, Lithuania, 08661 | |
| Principal Investigator: | Laimonas Griskevicius, PhD, MD | Vilnius University |
More Information
| Responsible Party: | VU hospital ( Laimonas Griskevicius ) |
| Study ID Numbers: | LT-CLL-001 |
| Study First Received: | November 13, 2007 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00558181 History of Changes |
| Health Authority: | Lithuania: Bioethics Committee; Lithuania: State Medicine Control Agency - Ministry of Health |
|
B CLL Chronic B Lymphocytic Leukemia Methylprednisolone Rituximab |
|
Anti-Inflammatory Agents Leukemia, Lymphoid Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Methylprednisolone Hemisuccinate |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Autonomic Agents Prednisolone Peripheral Nervous System Agents |