Status:
COMPLETED
Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CS...
Detailed Description
OBJECTIVES: Primary * Determine the safety and feasibility of autologous peripheral blood stem cell transplantation in patients with chronic lymphocytic leukemia treated with cyclophosphamide and to...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Patients with chronic lymphocytic leukemia, meeting 1 of the following criteria:
- Binet stage B or C disease
- Binet stage A disease and at high risk for disease progression, defined as the following:
- Non-nodular marrow infiltration or lymphocyte doubling time \< 12 months
- Thymidine kinase \> 7.0 U/L or ß-2-microglobulin \> 3.5 mg/L
- Polymerase chain reaction-amplifiable clonal CDRIII rearrangement of the IgV\_H
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- No concurrent disease resulting in major organ dysfunction
- PRIOR CONCURRENT THERAPY:
- No prior combination therapy comprising melphalan, dexamethasone, carmustine, cytarabine, and etoposide (DEXA-Beam)
- No more than 1 prior chemotherapy regimen
- No prior chemotherapy regimen longer than 6 months in duration
Exclusion
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00275015
Start Date
January 1 1998
End Date
April 1 2012
Last Update
May 11 2018
Active Locations (53)
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1
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, Austria, A-1090
2
Hanuschkrankenhaus
Vienna, Austria, A-1140
3
Humaine - Clinic
Bad Saarow, Germany, D-15526
4
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, D-12200