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Chronic Lymphocytic LeukemiaPhase 2NCT00275015

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

A Phase 2 study testing filgrastim, carmustine and cyclophosphamide in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 53 sites in 2 countries.

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 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… 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?
filgrastim, carmustine and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
53 sitesin 2 countries
Study dates
Jan 1998to Apr 2012
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:

  • 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

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

Germany51 sites

  • Humaine - Clinic

    Bad Saarow, D-15526

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Praxis Dres. F.& G. Doering

    Bremen, D-28205

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Michael Schaefers und Partner

    Duisburg, D-47051

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Malteser Krankenhaus

    Flensburg, D-24939

  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

    Giessen, D-35392

  • Universitätsklinikum Göttingen

    Göttingen, D-37075

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • St. Marien-Hospital Hamm - Klinik Knappenstrasse

    Hamm, D-59071

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

  • Universitatsklinikum Heidelberg

    Heidelberg, D-69120

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07740

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Gemeinschaftspraxis fuer Haematologie, Onkologie und Infektiologie

    Karlsruhe, D-76135

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, D-34117

  • Staedtisches Krankenhaus Kiel

    Kiel, D-23116

  • University Leipzig Clinic of Internal Medicine

    Leipzig, D-04103

  • Universitaets - Kinderklinik - Luebeck

    Lübeck, D-23538

  • Sana Kliniken Luebeck

    Lübeck, D-23560

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

    Magdeburg, D-39120

  • Universitatsklinik Mainz

    Mainz, D-55101

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, D-41063

  • Klinikum der Universitaet Muenchen - Innenstadt Campus

    Munich, D-80331

  • Krankenhaus Muenchen Schwabing

    Munich, D-80804

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • University of Muenster

    Münster, D-48129

  • Internistische Praxis - Neuss

    Neuss, D-41460

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, D-22844

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, D-26121

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Buergerhospital Stuttgart

    Stuttgart, D-70191

  • Internistische Praxis - Trier

    Trier, D-54290

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, D-65191

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, D-97070

  • University Wurzburg

    Würzburg, D-97070

Other trials in Germany

Austria2 sites

  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Vienna, A-1090

  • Hanuschkrankenhaus

    Vienna, A-1140

Other trials in Austria

About this study

Official title: 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.

Read the 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.

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, refractory 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.

Study groups in NCT00275015
Study groupRoleWhat they receive
High dose therapy + autologous PBSCTExperimental1. 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)
Receives: 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

What is being measured

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

  1. Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant

  2. Feasibility of PBSCT as measured by > 50% of included patients proceeding to transplant

Secondary outcomes (5)

  1. Safety of mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) as measured by a treatment-related mortality of < 5% before transplant phase

  2. Efficacy of Dexa-BEAM mobilization as measured by the amount of CD34+ cells > 4x10e6/kg at harvest

  3. Complete clinical remissions by NIH criteria at 3 months following transplant

  4. Molecular remissions by CDR3 PCR at 3 months following transplant

  5. Progression-free survival by NIH criteria at 5 years from study entry

Timeline

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

  1. First posted11 Jan 2006 (estimated)
  2. Study startJan 1998
  3. Study completionApr 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275015
Sponsor's protocol ID
CLL3
Other IDs
EU-20553
Status last verified
May 2018
First submitted
10 Jan 2006
Last updated
11 May 2018
Results posted
No

Publications

  • Dreger P, Dohner H, McClanahan F, Busch R, Ritgen M, Greinix H, Fink AM, Knauf W, Stadler M, Pfreundschuh M, Duhrsen U, Brittinger G, Hensel M, Schetelig J, Winkler D, Buhler 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.

    PubMed 22490331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, carmustine and cyclophosphamide in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 53 sites in 2 countries.

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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany, Austria. 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 of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant. The study lists 2 primary outcomes in all. 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 NCT00275015, which also lists 1 linked publication.

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 11 May 2018.

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