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Chronic Lymphocytic LeukemiaPhase 2NCT00276809

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 study testing alemtuzumab, filgrastim and carmustine in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
alemtuzumab, filgrastim and carmustine
Type of treatment
Surgery or procedure
How many people
30 participants
Where
12 sitesGermany
Study dates
Jun 2001to Sep 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitatsklinikum Heidelberg

    Heidelberg, D-69120

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120

  • Universitatsklinik Mainz

    Mainz, 55101

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

Other trials in Germany

About this study

Official title: Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia

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.

Being tested
alemtuzumab, filgrastim, carmustine, cyclophosphamide, cytarabine
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
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Rate and duration of molecular responses MRD levels continuous

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

  3. Overall survival time from treatment to death continuous

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2006 (estimated)
  2. Study startJun 2001
  3. Primary completionSep 2004
  4. Study completionSep 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276809
Sponsor's protocol ID
CLL3C
Other IDs
EU-20556, MEDAC-GCLLSG-CLL3C
Status last verified
Sep 2016
First submitted
12 Jan 2006
Last updated
26 Sep 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alemtuzumab, filgrastim and carmustine in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00276809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.

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