Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

Sponsor: Helse Fonna
Study ID: NCT02689986
Phase: PHASE2
Status: Completed

Conditions

Autoimmune Hemolytic Anemia
Cold Agglutinin Disease

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Bendamustine, Rituximab — DRUG
Bendamustine, Rituximab

Study Details

Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.

Key Dates

Start date: Jan 31, 2013
Status verified: Jan 2017
Primary completion: Dec 31, 2016
Completion: Dec 31, 2016

Study Design

Enrollment: 43 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Treatment arm
Bendamustine, Rituximab

Primary Outcome Measure

Frequency of complete and partial responses (CR/PR) [ Time Frame: 6 months ]

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PHASE2 · Not Yet Recruiting · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Boston, Massachusetts