NCT00147901

Brief Summary

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

September 2, 2005

Last Update Submit

September 30, 2016

Conditions

B-cell Chronic Lymphocytic Leukemia

Keywords

CLLImmunochemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (complete and partial response rate)

    Response Evaluation has to be done according the the NCI guidelines

    28 days after the end of the last cycle

Secondary Outcomes (6)

  • Toxicity

    28 days following the last dose of FCCam

  • MRD response rate

    28 days after the end of the last cycle

  • Response rate in biological defined risk groups

    28 days after the end of the last cycle

  • Duration of response

    up to 36 months after the end of treatment

  • Treatment administration (dose intensity)

    up to the last day of the last given cycle (day 28 of the 6th cycle)

  • +1 more secondary outcomes

Study Arms (1)

FCCam

EXPERIMENTAL

After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles

Drug: FCCam

Interventions

FCCamDRUG

After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles

Also known as: Fludarabine, Cyclophosphamide, Alemtuzumab
FCCam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • B-CLL in need of treatment
  • One or two prior prior therapies
  • WHO performance status 0-2

You may not qualify if:

  • Serum creatinine \> 1.5 ULN
  • Major organ dysfunctions
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (1)

  • Elter T, James R, Busch R, Winkler D, Ritgen M, Bottcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Buhler A, Dohner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination with alemtuzumab in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia. Leukemia. 2012 Dec;26(12):2549-52. doi: 10.1038/leu.2012.129. Epub 2012 May 15. No abstract available.

    PMID: 22584787RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabineCyclophosphamideAlemtuzumab

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)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andreas Engert

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2011

Last Updated

October 3, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)