Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease (CAD5)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02689986|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cold Agglutinin Disease Autoimmune Hemolytic Anemia||Drug: Bendamustine, Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Treatment arm
Drug: Bendamustine, Rituximab
Other Name: Levact, MabThera
- Frequency of complete and partial responses (CR/PR) [ Time Frame: 6 months ]
Responses will be assessed using the following, previously published definitions:
Complete response (CR), Absence of anemia, no signs of hemolysis, no clinical symptoms of CAD, undetectable serum monoclonal protein, and no signs of clonal lymphoproliferation by bone marrow histology, immunohistochemistry and flow cytometry.
Partial response (PR), Stable increase in hemoglobin levels by at least 2.0 g/dL or to the normal range, combined with a reduction of serum IgM concentrations by at least 50% or to the normal range, improvement of clinical symptoms, and transfusion independency.
Non-response (NR), Patients not meeting the criteria for CR or PR.
- Time to response (TTR) [ Time Frame: 6 months ]Time to response (TTR) is the time from start of therapy to the achievement of any degree of response.
- Time to best response (TTBR) [ Time Frame: 1 year ]Time to best response (TTBR) is the time from start of therapy to the observation of the highest hemoglobin level achieved + 0.5 g/dL.
- Response duration [ Time Frame: Through study completion; an average of 2 years ]Response duration is the time from achievement of any degree of response to relapse. Relapse is defined by one or more of the following events: A decline in hemoglobin level by at least 2.0 g/dL from the highest level achieved or to below 10.0 g/dL; transfusion requirement; or recurrence of significant cold-induced circulatory symptoms.
- Number of participants with treatment-related adverse events as assessed by current CTCAE criteria [ Time Frame: Through study completion; an average of 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689986
|Herlev University Hospital|
|Turku University Hospital|
|Haukeland University Hospital|
|Bergen, Norway, NO-5021|
|Vestre Viken Hospital|
|Drammen, Norway, NO-3000|
|Haugesund, Norway, NO-5504|
|Akershus University Hospital|
|Oslo University Hospital|
|Oslo, Norway, NO-0027|
|St Olav University Hospital|
|Trondheim, Norway, NO-7006|
|Study Chair:||Sigbjorn Berentsen, MD, PhD||Department of Research and Innovation, Haugesund Hospital|
|Principal Investigator:||Markku Oksman, MD||Turku University Hospital, Turku, Finland|
|Principal Investigator:||Henrik Birgens, MD, PhD||Herlev University Hospital, Copenhagen, Denmark|
|Principal Investigator:||Geir E Tjonnfjord, MD, PhD||Oslo University Hospital, Oslo, Norway|