Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
NCT ID: NCT00142181
Last Updated: 2012-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2003-03-31
2008-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Campath-1H
30 mg IV three times a week, 6-12 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Massachusetts General Hospital
OTHER
Bayer
INDUSTRY
University of California, Los Angeles
OTHER
Northwestern University
OTHER
Arizona Oncology Associates
NETWORK
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Steven P. Treon, MD, PhD
Principal Investigator
Principal Investigators
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Steven P. Treon, MD, MA, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Beth Isreal Deaconness Medical Center
Boston, Massachusetts, United States
Dana-farber Cancer Insitiute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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02-079
Identifier Type: -
Identifier Source: org_study_id