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Title:
A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
Protocol Number:
J11158
Phase:
Phase II
Physician:
Douglas Gladstone
Purpose:
The overall purpose of this study is to determine if MEDI-551, when used in combination with salvage chemotherapy (Bendamustine) in patients with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant, has superior efficacy compared to Rituximab in the same population.
Eligibility:
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: - Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function. Exclusion Criteria: - Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 42 days prior to treatment; - Exposure to bendamustine within the 180 days before study enrollment Prior autologous or allogeneic stem cell transplantation (SCT); - Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor; - History of other invasive malignancy within 5 years except for localized/in situ carcinomas such as cervical carcinoma in situ or basal/squamous skin cancer; - Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma.
Treatment:
Estimated Enrollment: 157 Study Start Date: February 2012 Estimated Study Completion Date: December 2015 Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure) ARMS: EXPERIMENTAL: MEDI-551 (dose level 1) + Bendamistine - Drug: MEDI-551 MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles. - Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion). EXPERIMENTAL: MEDI-551 (dose level 2) + Bendamustine - Drug: MEDI-551 MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles. - Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion). ACTIVE COMPARATOR: Rituximab + Bendamustine - Drug: Rituximab Rituximab will be administered at 375 mg/m2 by IV infusion on Day 1 of Cycle 1 and then at 500 mg/m2 on Day 1 of up to 5 subsequent 28-day cycles (90-minute infusion). Other Name: Rituxan; MabThera - Drug: Bendamustine Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion).
Population:
Adult
Last Update
04/19/2014 04:02 AM
 

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