Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia

NCT00276809 | Completed Phase 2

• 3 other identifiers: CLL3CEU-20556MEDAC-GCLLSG-CLL3C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Giving combination chemotherapy before a peripheral blood 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. A monoclonal antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and radiation therapy (total-body irradiation) are 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. Giving combination chemotherapy, total-body irradiation, and alemtuzumab together with autologous peripheral stem cell transplant may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with total-body irradiation and alemtuzumab works in treating patients undergoing an autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.

Conditions

Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility of CAMPATH-1H included into the myeloablative regimen (cyclophosphamide and TBI) of the CLL3 protocol monitoring of treatment related mortality and morbidity (CTC scale) continuous

Secondary Outcomes (3)

• Rate and duration of molecular responses MRD levels continuous

• Rate and duration of clinical remissions NCIE sponsored remission criteria for CLL continuous

• Overall survival time from treatment to death continuous

Interventions

alemtuzumab BIOLOGICAL

filgrastim BIOLOGICAL

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide DRUG

fludarabine phosphate DRUG

melphalan DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Chronic lymphocytic leukemia (CLL), meeting 1 of the following stage criteria: * Stage I-IV disease * Binet stage B or C disease * Binet stage A disease at high risk for rapid disease progression, as defined by both of the following criteria: * Nonnodular marrow infiltration and/or lymphocyte doubling time \< 12 months * Thymidine kinase \> 7.0 U/L and/or ß-2-microglobulin \> 3.5 mg/L * Polymerase chain reaction-amplifiable clonal CDR III rearrangement of the immunoglobulin variable heavy chain gene * No Richter's syndrome or B-prolymphocytic leukemia PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * No concurrent disease resulting in major organ dysfunction * Not pregnant or nursing * Fertile patients must use effective contraception * No other concurrent malignancy * No New York Heart Association class III or IV cardiac failure * No cardiomyopathy * No history of myocardial infarction * No symptomatic coronary heart disease * No severe cardiac arrhythmia * No severe or uncontrolled hypertension * No chronic pulmonary disease * No pulmonary function test impairment * No severe or uncontrolled diabetes mellitus * Bilirubin or transaminases ≤ 1.5 times upper limit of normal * Creatinine ≤ 1.4 mg/dL * No cerebral dysfunction * No severe psychiatric impairment * No drug addiction or alcoholism * Negative HIV * Negative Hepatitis B or C * No allergy to any of the protocol drugs * No history of anaphylactic reaction to monoclonal antibodies * No active infection PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen OR chemotherapy that lasted \> 6 months * No prior radiotherapy * No prior treatment with alemtuzumab * No prior long-term (\> 1 month) systemic corticosteroids * No prior therapy with dexamethasone, carmustine, etoposide, cytarabine, and melphalan (Dexa-BEAM)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German CLL Study Group: lead

Study Sites (12)

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitatsklinikum Heidelberg

Heidelberg, D-69120, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Universitatsklinik Mainz

Mainz, 55101, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

Related Links

• German CLL Study Group

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab; Filgrastim; Carmustine; Cyclophosphamide; Cytarabine; Dexamethasone; Etoposide; fludarabine phosphate; Melphalan; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Stephan Stilgenbauer, MD

  Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: June 1, 2001
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

DE (12)