Clinical trial NCT00142181: Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
Official title: Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoplasmacytic Lymphoma
Waldenstrom's Macroglobulinemia
Keywords: Lymphoplasmacytic lymphoma
Waldenstrom's Macroglobulinemia
Antibody
Campath-1H
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Bayer
name: University of California, Los Angeles
name: Northwestern University
name: Arizona Oncology Associates
First posted: 2005-09-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the safety of Campath-1H.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Isreal Deaconness Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-farber Cancer Insitiute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Steven P. Treon, MD, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.