Suspended

Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

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What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders
+13

+ Cardiovascular Diseases
+ Hematologic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab. * Determine the time to treatment failure in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Official TitlePhase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia) 
NCT00081068
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Waldenstrom Macroglobulinemia
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Hemostatic Disorders
Neoplasms, Plasma Cell
Criteria

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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 15 locations
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United StatesSee the location
Suspended
Rocky Mountain Cancer Centers - Denver MidtownDenver, United States
Suspended
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, United States
Suspended
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, United States

Suspended15 Study Centers
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