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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275015
First Posted: January 11, 2006
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
German CLL Study Group
January 10, 2006
January 11, 2006
February 24, 2017
January 1998
Not Provided
  • Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
  • Feasibility of PBSCT as measured by > 50% of included patients proceeding to transplant
Not Provided
Complete list of historical versions of study NCT00275015 on ClinicalTrials.gov Archive Site
  • Safety of mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) as measured by a treatment-related mortality of < 5% before transplant phase
  • Efficacy of Dexa-BEAM mobilization as measured by the amount of CD34+ cells > 4x10e6/kg at harvest
  • Complete clinical remissions by NIH criteria at 3 months following transplant
  • Molecular remissions by CDR3 PCR at 3 months following transplant
  • Progression-free survival by NIH criteria at 5 years from study entry
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • 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
Experimental: High dose therapy + autologous PBSCT
  1. Cytoreductive treatment: (preferentially) FC (2-4 cycles)
  2. Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
  3. Myeloablation:

    fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3)

  4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
Interventions:
  • 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
Dreger P, Döhner H, McClanahan F, Busch R, Ritgen M, Greinix H, Fink AM, Knauf W, Stadler M, Pfreundschuh M, Dührsen U, Brittinger G, Hensel M, Schetelig J, Winkler D, Bühler A, Kneba M, Schmitz N, Hallek M, Stilgenbauer S; German CLL Study Group. Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the German CLL Study Group CLL3 trial. Blood. 2012 May 24;119(21):4851-9. doi: 10.1182/blood-2011-09-378505. Epub 2012 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
April 2012
Not Provided

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
 
NCT00275015
CLL3
EU-20553
Not Provided
Not Provided
Not Provided
Not Provided
German CLL Study Group
Not Provided
Study Chair: Peter Dreger Universitaets-Kinderklinik Heidelberg
German CLL Study Group
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP