CompletedNCT00276809Updated Sep 26, 2016

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

A Phase 2 interventional study of alemtuzumab and filgrastim in Chronic Lymphocytic Leukemia, sponsored by German CLL Study Group. Completed at 12 sites in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by German CLL Study Group · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 30
Allocation: Non-randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Read the detailed description

OBJECTIVES:

Primary

Determine the safety and feasibility of cytoreductive fludarabine and cyclophosphamide followed by high-dose myeloablative therapy comprising total-body irradiation, cyclophosphamide, and alemtuzumab in patients undergoing autologous filgrastim (G-CSF)-mobilized peripheral blood stem cell transplantation for stage I-IV chronic lymphocytic leukemia.

Secondary

Determine the clinical and molecular remission rate and duration in patients treated with this regimen.
Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are assigned to 1 of 2 cohorts according to time of enrollment.

Cytoreductive induction therapy: All patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) proceed to stem cell mobilization. Patients with stage III or IV disease at this point are removed from study.
Stem cell mobilization: All patients receive Dexa-BEAM comprising oral dexamethasone once daily on days 1-10; carmustine IV and melphalan IV on day 2; and cytarabine IV twice daily and etoposide IV once daily on days 4-7. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 8 and continuing until leukapheresis is completed. Patients undergo peripheral blood stem cell (PBSC) harvest between days 20 and 28. Patients without an adequate number of collected PBSCs may receive a second course of Dexa-BEAM. Patients achieving CR or very good PR proceed to high-dose myeloablative therapy and PBSC transplantation (PBSCT) with or without consolidation therapy.
Consolidation therapy: Beginning between 1-2 months after completion of Dexa-BEAM, patients in cohort 2 receive alemtuzumab IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and then proceed to high-dose myeloablative therapy and PBSCT within 1 month after completion of consolidation therapy. Patients in cohort 1 do not receive consolidation therapy and proceed directly to high-dose therapy within 3 months after completion of stem cell mobilization.
High-dose myeloablative therapy and PBSCT: Patients undergo total-body irradiation on days -7 to -5. Patients then receive cyclophosphamide IV on days -4 and -3 and alemtuzumab IV over 2 hours on days -10, -9, -8, -6, and -4. Patients undergo PBSCT on day 0.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions studied

Chronic Lymphocytic Leukemia

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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

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 30 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

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Lead sponsor

German CLL Study Group is the lead sponsor of 36 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Masking: None (open label)
Enrollment: 30 participants (estimated)

Interventions

Biologicalalemtuzumab
Biologicalfilgrastim
Drugcarmustine
Drugcyclophosphamide
Drugcytarabine
Drugdexamethasone
Drugetoposide
Drugfludarabine phosphate
Drugmelphalan
Procedureautologous bone marrow transplantation
Procedureperipheral blood stem cell transplantation
Radiationradiation therapy

What researchers measure

Primary outcomes

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

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

Study locations

12 sites

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Asklepios Klinik St. Georg
Hamburg, D-20099, Germany
Medizinische Hochschule Hannover
Hannover, D-30625, Germany
Universitatsklinikum Heidelberg
Heidelberg, D-69120, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133, Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24105, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, D-39120, Germany
Universitatsklinik Mainz
Mainz, 55101, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00276809
Lead sponsor: German CLL Study Group
First posted: Jan 13, 2006
Start date: Jun 2001
Primary completion: Sep 2004
Completion: Sep 2004
Last update: Sep 26, 2016

Study contacts

Stephan Stilgenbauer, MD

study chair · Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

View the source record on ClinicalTrials.gov ↗

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