NCT00086775

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2003

Typical duration for phase_2 leukemia

Geographic Reach
1 country

5 active sites

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

July 1, 2003

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

July 8, 2004

Last Update Submit

August 1, 2013

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemia

Interventions

alemtuzumabBIOLOGICAL
rituximabBIOLOGICAL
fludarabine phosphateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as: * Peripheral lymphocyte count \> 5,000/mm\^3 * Clonal CD5-, CD19-, and CD23-positive lymphocytes * Refractory to OR relapsed after prior first-line therapy * No CNS involvement with CLL PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine ≤ 1.5 times ULN Immunologic * No active cytomegalovirus * No prior fludarabine-associated autoimmune hemolytic anemia or immune thrombocytopenic purpura * No active infection requiring treatment with antibiotic, antiviral, or antifungal agents * No prior significant allergic reaction to antibody therapies that required therapy to be discontinued * HIV negative Other * No active secondary malignancy * No other concurrent severe diseases or mental disorders * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior alemtuzumab and/or rituximab * No prior bone marrow transplantation * No concurrent thrombopoietin or pegfilgrastim Chemotherapy * More than 3 weeks since prior fludarabine Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 3 months since prior investigational drugs * No other concurrent cytotoxic therapy

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

Sponsors & Collaborators

Study Sites (5)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Cancer Institute of New Jersey at Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, 15224, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

AlemtuzumabRituximabfludarabine 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-Derived

Study Officials

  • Ann S. LaCasce, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

July 1, 2003

Primary Completion

June 1, 2005

Study Completion

October 1, 2009

Last Updated

August 2, 2013

Record last verified: 2009-10

Locations

US(5)