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Monoclonal Antibodies
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
Phase 2
Waitlist Available
Led By Steven P. Treon, MD, MA, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Lymphoplasmacytic Lymphoma
- Waldenström's Macroglobulinemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2013 Phase 2 & 3 trial • 7 Patients • NCT00775931100%
Acute Sinusitis
100%
Atelectasis
100%
Fungal Infection, Respiratory
100%
Pericardial Effusion
100%
Bacterial Infection, Respiratory
100%
Bacterial Infection, Feces
100%
Blood Clot in Bladder Wall
100%
Fungal Infection, Feces
100%
Requires Hemodialysis, NOS
100%
Hyperechogenic Renomegaly with Ascites
100%
Requires Intubation, NOS
100%
Large Splenic Infarct
100%
Low Lung Volumes
100%
Pneumonia
100%
Pulmonary Hemorrhage
100%
Small Bowel Ascites
100%
Viral Infection, Blood
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cord Blood Transplant Conditioning
Marrow Graft Transplant Conditioning
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Campath-1HExperimental Treatment1 Intervention
30 mg IV three times a week, 6-12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
FDA approved
Find a Location
Who is running the clinical trial?
Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,488 Total Patients Enrolled
BayerIndustry Sponsor
2,277 Previous Clinical Trials
25,541,086 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,239 Total Patients Enrolled
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,314,262 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
861 Previous Clinical Trials
12,932,799 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,854 Total Patients Enrolled
Arizona Oncology AssociatesNETWORK
1 Previous Clinical Trials
438 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,762 Total Patients Enrolled
Steven P. Treon, MD, MA, PhDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
78 Total Patients Enrolled