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

Lymphoplasmacytic Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142181
• Other study ID #: 02-079
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: December 19, 2012
• Start date: March 2003
• Est. completion date: June 2008

Study information

• Verified date: December 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2008
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoplasmacytic Lymphoma
• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia

Intervention

Drug:
• Campath-1H
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.

Locations

Country	Name	City	State
United States	Beth Isreal Deaconness Medical Center	Boston	Massachusetts
United States	Dana-farber Cancer Insitiute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Arizona Oncology Associates, Bayer, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Northwestern University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenström macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.		2 years	No
Secondary	To determine the safety of Campath-1H.		2 years	Yes