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Chronic Lymphocytic LeukemiaPhase 2NCT00309881

Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 18 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: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
rituximab, cyclophosphamide and doxorubicin hydrochloride
How many people
75 participants
Where
18 sitesGermany
Study dates
Apr 2003to Mar 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of previously treated chronic lymphocytic leukemia (CLL) meeting the following criteria:
  • Binet stage B (Rai stages I and II) or Binet stage C (Rai stages III and IV) disease
  • Rapid disease progression, symptomatic enlarged lymph nodes, or severe B-cell symptoms
  • CLL with autoimmune hemolytic anemia allowed
  • Richter transformation allowed

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • ECOG performance status 0-3
  • No severe organ dysfunction
  • No other prior or concurrent neoplasms

PRIOR CONCURRENT THERAPY:

  • No more than 4 prior chemotherapy regimens

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Kreiskrankenhaus

    Bad Hersfeld, 36251

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, 28239

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

    Giessen, 35392

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, 58095

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • Praxis fur Innere Medizin - Hamburg

    Hamburg, 22457

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Marienhospital at Ruhr University Bochum

    Herne, D-44625

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, 34117

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Marienhospital Stuttgart

    Stuttgart, 70199

  • Haematologische Praxis

    Weiden, D-92637

  • Medizinische Poliklinik, Universitaet Wuerzburg

    Würzburg, D-97070

Other trials in Germany

About this study

Official title: CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with chronic lymphocytic leukemia (CLL) that has not responded to fludarabine (closed to entry as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy, in terms of the rate and quality of remission, of chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and rituximab (CHOP-R) in patients with fludarabine-refractory chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006), CLL with autoimmune hemolytic anemia, or Richter transformation.
  • Determine the incidence of infection in patients on CHOP-R regimen.

Secondary

  • Determine the toxicity of this regimen in these patients
  • Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a prospective, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia (CLL) (closed to accrual as of 10/2006) vs CLL with autoimmune hemolytic anemia vs Richter transformation).

Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive rituximab IV on day 1 of the second course and each subsequent course. Treatment repeats every 21 days for up to 6 (for patients with CLL) or 8 (for patients with Richter's transformation) courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Keywords
refractory 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. Rate of remission

  2. Quality of remission

Secondary outcomes (3)

  1. Toxicity

  2. Progression-free survival

  3. Overall survival

Timeline

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

  1. First posted3 Apr 2006 (estimated)
  2. Study startApr 2003
  3. Primary completionMar 2006
  4. Study completionMar 2011

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
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309881
Sponsor's protocol ID
CLL2G
Other IDs
EU-20549, GCLLSG-423, MEDAC-GCLLSG-CLL2G
Status last verified
Sep 2016
First submitted
29 Mar 2006
Last updated
3 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Langerbeins P, Busch R, Anheier N, Durig J, Bergmann M, Goebeler ME, Hurtz HJ, Stauch MB, Stilgenbauer S, Dohner H, Fink AM, Cramer P, Fischer K, Wendtner CM, Hallek M, Eichhorst B. Poor efficacy and tolerability of R-CHOP in relapsed/refractory chronic lymphocytic leukemia and Richter transformation. Am J Hematol. 2014 Dec;89(12):E239-43. doi: 10.1002/ajh.23841. Epub 2014 Sep 26.

    PubMed 25196783

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 18 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Rate of remission. 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 NCT00309881, 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 3 Oct 2016.

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