NCT00337519

Brief Summary

Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting. Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

6.3 years

First QC Date

June 15, 2006

Last Update Submit

January 28, 2009

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemiareduced intensity conditioningalemtuzumaballogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    400 days

Secondary Outcomes (5)

  • safety according to common toxicity criteria (CTC)

    at discharge and until last follow up

  • rate of primary and secondary graft failure

    until last follow up

  • rate of acute and chronic GVHD

    day 100 and last follow up

  • response rate

    2 years

  • chimerism

    day 100

Study Arms (1)

1

EXPERIMENTAL

see detailed description

Procedure: allogeneic stem cell transplantationDrug: Alemtuzumab

Interventions

allogeneic stem cell transplantationPROCEDURE

see detailed description

1
AlemtuzumabDRUG

alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14

1

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • sufficient organ function
  • availability of an HLA-compatible donor (related or unrelated)
  • age \< 65 years
  • karnofsky index \> = 70%
  • B-CLL requiring treatment after failure of at least one prior cytostatic treatment

You may not qualify if:

  • positive HIV-serology
  • pregnancy
  • intolerance to study drugs
  • second neoplasia
  • serious infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Chemnitz gGmbH

Chemnitz, Chemnitz, 09113, Germany

Location

Uniklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Deutsche Klinik für Diagnostik GmbH

Wiesbaden, 65191, Germany

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Johannes Schetelig, MD

    University Hospital Carl Gustav Carus, Dresden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

January 1, 2003

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

DE(3)