NCT00416910

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of combination chemotherapy. It is not yet known whether giving combination chemotherapy alone is more effective than combination chemotherapy together with G-CSF in treating patients with chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together with G-CSF to see how well it works compared to giving combination chemotherapy alone in treating patients with relapsed stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_3

Status
terminated

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

July 1, 1999

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

4.2 years

First QC Date

December 27, 2006

Last Update Submit

September 23, 2016

Conditions

Chronic Lymphocytic Leukemia

Keywords

refractory chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemia

Study Arms (2)

FCM

ACTIVE COMPARATOR

Fludarabine i.v. (25 mg/m2/d, d1-3) Cyclophosphamide i.v. (200 mg/m2/d, d1-3) Mitoxantrone i.v. (8 mg/m2, d1) q28d, max. 6 cycles

Drug: FludarabineDrug: CyclophosphamideDrug: Mitoxantrone

FCM + G-CSF

EXPERIMENTAL

Fludarabine i.v. (25 mg/m2/d, d1-3) Cyclophosphamide i.v. (200 mg/m2/d, d1-3) Mitoxantrone i.v. (8 mg/m2, d1) Filgrastim (G-CSF) s.c. (5 µg/kg/d beginning on day +6 until neutrophil recovery above 1500/µl.) q28d, max. 6 cycles

Biological: FilgrastimDrug: FludarabineDrug: CyclophosphamideDrug: Mitoxantrone

Interventions

FilgrastimBIOLOGICAL
Also known as: Neupogen
FCM + G-CSF
FludarabineDRUG
FCMFCM + G-CSF
CyclophosphamideDRUG
FCMFCM + G-CSF
MitoxantroneDRUG
FCMFCM + G-CSF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Confirmed relapsed and advanced chronic lymphocytic leukemia (CLL) * Binet stage B or C disease with rapid disease progression, enlarged lymph nodes and organs, or severe B-symptoms * No prior non-response to fludarabine combination therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy \> 6 months * No severe organ dysfunction * No other prior or concurrent neoplasm, autoimmune hemolytic anemia, or thrombocytopenia PRIOR CONCURRENT THERAPY: * No more than three previous treatment regimens for CLL (fludarabine allowed)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimfludarabineCyclophosphamideMitoxantrone

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)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicQuinonesPolycyclic Compounds

Study Officials

  • Michael Hallek, MD

    Medizinische Universitaetsklinik I at the University of Cologne

    PRINCIPAL INVESTIGATOR

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

December 27, 2006

First Posted

December 28, 2006

Study Start

July 1, 1999

Primary Completion

September 1, 2003

Study Completion

September 1, 2007

Last Updated

September 26, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share