A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Chronic Lymphocytic Leukemia (CLL)

Treatments: Drug: Bendamustine; Drug: Rituximab; Drug: MEDI-551

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466153

CD-ON-MEDI-551-1019

Details and patient eligibility

About

The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

Enrollment: 183 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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 28 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;
• Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 3 patient groups

Rituximab + Bendamustine

Active Comparator group

Description:

Rituximab was administered by IV infusion as 375 mg/m\^2 on Day 2 of Cycle 1 and then 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.

Treatment:

Drug: Bendamustine

Drug: Rituximab

MEDI-551 2 mg/kg + Bendamustine

Experimental group

Description:

MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.

Treatment:

Drug: Bendamustine

Drug: MEDI-551

MEDI-551 4 mg/kg + Bendamustine

Experimental group

Description:

MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.

Treatment:

Drug: Bendamustine

Drug: MEDI-551