NCT00275015

Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia

Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an peripheral stem cell transplant for chronic lymphocytic leukemia.

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 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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	carmustine
DRUG	cyclophosphamide
DRUG	cytarabine
DRUG	dexamethasone
DRUG	etoposide
DRUG	fludarabine phosphate
DRUG	melphalan
PROCEDURE	bone marrow ablation with stem cell support
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	radiation therapy

Timeline

• Start date: 1998-01-01
• Completion: 2012-04-01
• First posted: 2006-01-11
• Last updated: 2018-05-11

Locations

53 sites across 2 countries: Austria, Germany