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Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia Clinical research trials and Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia clinical trial. Human subjects often get the best healthcare possible for their Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia  Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 2 chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia,stage 3 chronic lymphocytic leukemia,refractory chronic lymphocytic leukemia,stage 4 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of remission induction therapy using cladribine combined with rituximab followed by rituximab and stem cell mobilization in treating patients who have chronic lymphocytic leukemia.
Details: OBJECTIVES: Primary - Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia. - Determine the complete remission rate in patients treated with this regimen. Secondary - Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen. - Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in these patients. - Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients. - Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab. OUTLINE: This is a multicenter study. - Patients receive cladribine subcutaneously (SC) on days 1-5. During courses 2-4, patients also receive rituximab IV on day 1. Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity. If unacceptable toxicity persists, patients receive rituximab alone. Patients not achieving a complete remission (CR), very good partial remission (VGPR), or nodular partial remission (NPR) receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for up to 4 courses or until patients achieve a CR, VGPR, or NPR. Patients achieving a CR, VGPR, or NPR proceed to stem cell mobilization and in vivo purging. - Stem cell mobilization and in vivo purging: Beginning 8-10 weeks after the first day of the last course of remission induction or CHOP, patients receive rituximab IV on days 1 and 8, cyclophosphamide IV over 4 hours on day 2, and filgrastim (G-CSF) SC daily beginning on day 4 and continuing until the last day of apheresis. Patients undergo apheresis on days 11-14. PROJECTED ACCRUAL: A total of 17-41 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of B-cell chronic lymphocytic leukemia (CLL) - CD5 positive and CD23 positive - Binet stage B, C, or progressive A - Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone) PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - No autoimmune hemolytic anemia - No immune thrombocytopenia Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN* - AST and ALT no greater than 2.5 times ULN* NOTE: *Unless clearly related to CLL liver involvement Renal - Creatinine clearance greater than 50 mL/min Cardiovascular - Ejection fraction at least 50% - No severe heart failure - No unstable angina pectoris - No significant arrhythmia requiring chronic treatment - No myocardial infarction within the past 3 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after study participation - HIV negative - No active infection - No positive Coombs’ test - No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia - No seizure disorder - No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix - No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents - No uncontrolled diabetes mellitus - No gastric ulcers - No active autoimmune disease - No alcohol or drug abuse - No other concurrent serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior purine analogs (e.g., cladribine or fludarabine) Endocrine therapy - Not specified Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 30 days since prior clinical trial participation - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ReinhardZenhaeusern, Study Chair, Inselspital, Bern
Ospedale San Giovanni *Recruiting*
Bellinzona, , CH-6500
Switzerland
Recruiting Leda Leoncini 41-91-820-9260
Kantonsspital - St. Gallen *Recruiting*
St. Gallen, , CH-9007
Switzerland
Recruiting Urs Hess 41-71-494-1111
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Anne Rosselet 41-21-314-0525
Kantonspital Aarau *Recruiting*
AARAU, , 5001
Switzerland
Recruiting Mario Bargetzi 41-62-838-6050
UniversitaetsSpital *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Jacky Emmanuel 41-1-255-2214
Ratisches Kantons und Regionalspital *Recruiting*
Chur, , CH-7000
Switzerland
Recruiting Fritz Egli 41-81-256-6111
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Reinhard Zenhaeusern 41-31-632-4114
Kantonsspital, Luzern *Recruiting*
Luzern, , CH-6000
Switzerland
Recruiting Michael Gregor 41-61-205-5147
Onkozentrum *Recruiting*
Zurich, , 8038
Switzerland
Recruiting Juerg Gmuer 41-1-209-2444
Hopital des Cadolles, Neuchatel *Recruiting*
Neuchatel, , 2000
Switzerland
Recruiting D. Piguet 41-32-722-9464
Additional Information:
Study ID Numbers: CDR0000335110; SWS-SAKK-34/02,EU-20321
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072007
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
2. Compassionate Use Program of Campath-1H in Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia
3. Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
4. Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
5. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Clinical Trials
Other Neuchatel Clinical Trials
Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
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