NCT00081068

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

Trial Health

45
At Risk

Trial Health Score

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

Geographic Reach
5 countries

15 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

First QC Date

April 7, 2004

Last Update Submit

January 7, 2013

Conditions

Lymphoma

Keywords

Waldenström macroglobulinemia

Outcome Measures

Primary Outcomes (3)

  • Objective response

  • Time to treatment failure

  • Toxicity

Interventions

alemtuzumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma) * Immunoglobulin (Ig) M, IgG, and IgA paraprotein * Measurable monoclonal paraprotein * Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab) * CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 500/mm\^3 * Platelet count ≥ 25,000/mm\^3 Hepatic * SGOT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN Renal * Creatinine ≤ 2.5 mg/dL (\> 2.5 mg/dL allowed if due to disease) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception during and for 6 months after study participation * No serious comorbid disease * No uncontrolled bacterial, fungal, or viral infection * No other active malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior alemtuzumab * More than 3 months since other prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * More than 21 days since prior chemotherapy Endocrine therapy * More than 21 days since prior steroid therapy Radiotherapy * More than 21 days since prior radiotherapy Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (15)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Rocky Mountain Cancer Centers - Denver Midtown

Denver, Colorado, 80218, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, ON L8N 3Z5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2C1, Canada

Location

Centre Hospitalier Lens

Lens, 62307, France

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

LymphomaWaldenstrom Macroglobulinemia

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jennifer Gansert, MD, PhD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

January 1, 2004

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

CA(2)FR(1)US(10)AU(1)GB(1)