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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoplasmacytic Lymphoma, Waldenstrom's Macroglobulinemia

Intervention / Treatment
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* Drug: Campath-1H


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Campath-1H<br>30 mg IV three times a week, 6-12 weeks. | Drug: Campath-1H<br>* Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of Campath-1H. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoplasmacytic lymphoma, Waldenstrom's Macroglobulinemia, Antibody, Campath-1H