Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
18 Years
60 Years
Both
Leukemia
Trial Information
Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
OBJECTIVES:
Primary
- Determine the safety and feasibility of autologous peripheral blood stem cell
transplantation in patients with chronic lymphocytic leukemia treated with
cyclophosphamide and total-body irradiation.
Secondary
- Determine the safety, feasibility, and efficacy of combination therapy comprising
dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) and
filgrastim (G-CSF) mobilization in patients treated with this regimen.
- Determine the efficacy of ex-vivo graft purging in patients treated with this regimen.
- Determine the incidence of complete clinical and molecular remissions in patients
treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
- Cytoreductive treatment: Patients undergo 2-4 courses of cytoreductive treatment,
preferably following the fludarabine and cyclophosphamide (FC) protocol.
- Stem cell mobilization: Patients achieving a complete remission (CR) or partial
remission (PR) and stable blood counts undergo stem cell mobilization comprising
dexamethasone, carmustine, cytarabine, etoposide, melphalan (Dexa-BEAM), and filgrastim
(G-CSF). Patients with an adequate number of mobilized cells undergo stem cell
collection. Patients with CR or very good PR proceed to myeloablative therapy.
- Myeloablative therapy: Patients undergo total-body irradiation on day -4 and receive
cyclophosphamide IV on days -4 and -3.
- Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo
autologous PBSCT on day 0.
After completion of study, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
Safety Issue:
Yes
Principal Investigator
Peter Dreger
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaets-Kinderklinik Heidelberg
Authority:
United States: Federal Government
Study ID:
CDR0000455090
NCT ID:
NCT00275015
Start Date:
January 1998
Completion Date:
Related Keywords:
- Leukemia
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- refractory chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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