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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00142181
Other study ID # 02-079
Secondary ID
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


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
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