Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

Phase 2

Completed

• Conditions: Lymphoplasmacytic Lymphoma; Waldenstrom's Macroglobulinemia
• Interventions: Drug: Campath-1H

• Registration Number: NCT00142181
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

Detailed Description

* Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.

* After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.

* If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.

* If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.

* No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.

* While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2005-10
• Study Completion: 2008-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
• Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
• Age greater than 18 years
• Life expectancy of 6 months or greater
• ECOG performance status of 0-2

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Exclusion Criteria

• Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
• Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
• Pregnant women
• Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Campath-1H	Campath-1H	30 mg IV three times a week, 6-12 weeks.

Primary Outcome Measures

Name	Time	Method
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.	2 years

Secondary Outcome Measures

Name	Time	Method
To determine the safety of Campath-1H.	2 years

Trial Locations

Locations (3)

Beth Isreal Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-farber Cancer Insitiute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States