NCT00564512

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P25-P50 for phase_3 leukemia

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 25, 2013

Status Verified

April 1, 2009

Enrollment Period

1.2 years

First QC Date

November 27, 2007

Last Update Submit

July 24, 2013

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival at 36 months

    36 months follow up

Secondary Outcomes (8)

  • Disease-free survival

    36 months follow up

  • Event-free survival

    36 months follow up

  • Overall survival

    36 months follow up

  • Time to next treatment

    36 months follow up

  • Overall response rate (complete response [CR] and partial response [PR])

    36 months follow up

  • +3 more secondary outcomes

Study Arms (2)

FCCAM

EXPERIMENTAL

Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation

Biological: rituximabDrug: cyclophosphamideDrug: fludarabine

FCR

ACTIVE COMPARATOR

Fludarabine-Cyclophosphamide-Rituximab (FCR) First course: Rituximab 375 mg/m2 on D1. D2 to D4: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon Subsequent courses (2 to 6) Rituximab 500 mg/m2 on D1 D1 to D3: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon

Biological: CampathDrug: cyclophosphamide

Interventions

CampathBIOLOGICAL

Fludarabine-Cyclophosphamide-Campath (FCCam)

Also known as: Alemtuzumab
FCR
rituximabBIOLOGICAL

Fludarabine-Cyclophosphamide-Rituximab (FCR)

Also known as: Mabthera®
FCCAM
cyclophosphamideDRUG

Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)

Also known as: Endoxan®
FCCAMFCR
fludarabineDRUG

Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)

Also known as: Fludara®
FCCAM

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL), meeting the following criteria:
  • Binet classification stages B or C
  • Del 17 p (FISH) negative (\< 10 % positives cores)
  • Matutes score 4 or 5
  • PATIENT CHARACTERISTICS:
  • Life expectancy \< 6 months
  • Creatinine clearance \< 60 mL/min
  • Total bilirubin \> 2 x upper limit of normal (ULN)
  • Gamma glutamyltransferase or transaminase levels \> 2 x ULN
  • Cumulative illness rating scale \> 6
  • HIV seropositivity
  • Hepatitis B or C seropositivity (unless clearly due to vaccination)
  • Clinically significant autoimmune anemia
  • Active bacterial, viral, or fungal infection
  • Active second malignancy currently requiring treatment (except basal cell carcinoma or in situ endometrial carcinoma) and/or less than 5 years complete remission after breast cancer
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (2)

  • Grgurevic S, Montilla-Perez P, Bradbury A, Gilhodes J, Queille S, Pelofy S, Bancaud A, Filleron T, Ysebaert L, Recher C, Laurent G, Fournie JJ, Cazaux C, Quillet-Mary A, Hoffmann JS. DNA polymerase nu gene expression influences fludarabine resistance in chronic lymphocytic leukemia independently of p53 status. Haematologica. 2018 Jun;103(6):1038-1046. doi: 10.3324/haematol.2017.174243. Epub 2018 Mar 22.

    PMID: 29567785DERIVED

  • Lepretre S, Aurran T, Mahe B, Cazin B, Tournilhac O, Maisonneuve H, Casasnovas O, Delmer A, Leblond V, Royer B, Corront B, Chevret S, Delepine R, Vaudaux S, Van Den Neste E, Bene MC, Letestu R, Cymbalista F, Feugier P. Excess mortality after treatment with fludarabine and cyclophosphamide in combination with alemtuzumab in previously untreated patients with chronic lymphocytic leukemia in a randomized phase 3 trial. Blood. 2012 May 31;119(22):5104-10. doi: 10.1182/blood-2011-07-365437. Epub 2012 Feb 14.

    PMID: 22337714DERIVED

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

AlemtuzumabRituximabCyclophosphamidefludarabinefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-DerivedPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Stephane Lepretre, MD

    Centre Henri Becquerel

    STUDY CHAIR

  • Pierre Feugier

    CHU de Nancy - Hopitaux de Brabois

    PRINCIPAL INVESTIGATOR

  • Roselyne DELEPINE, mrs

    Groupe Est Ouest Etudes leucemies et Autres Maladies du Sang

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Study Completion

July 1, 2013

Last Updated

July 25, 2013

Record last verified: 2009-04

Locations

FR(1)