Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
Steven P. Treon, MD, MA, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-farber Cancer Insitiute||Boston, Massachusetts 02115|
|Beth Isreal Deaconness Medical Center||Boston, Massachusetts 02115|