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

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

Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Bayer, University of California, Los Angeles, Northwestern University, Arizona Oncology Associates

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.

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.

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.

To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.

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.

Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 2011 Jul 14;118(2):276-81. doi: 10.1182/blood-2011-02-338558. Epub 2011 May 12.