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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466153
• Other study ID #: CD-ON-MEDI-551-1019
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2011
• Last updated: March 1, 2016
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The overall purpose of the 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 (ASCT), has superior efficacy compared to rituximab in the same population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• MEDI-551
MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles.
• Rituximab
Rituximab will be administered at 375 mg/m2 by IV infusion on Day 2 of Cycle 1 and then at 500 mg/m2 on Day 1 of up to 5 subsequent 28-day cycles (90-minute infusion).
• 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).

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Arlon
Belgium	Research Site	Kortrijk
Belgium	Research Site	Mons
Belgium	Research Site	Wilrijk
Belgium	Research Site	Yvoir
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
France	Research Site	Amiens
France	Research Site	Bayonne
France	Research Site	Bordeaux
France	Research Site	Le Mans
France	Research Site	Libourne Cedex
France	Research Site	Marseille
France	Research Site	Nimes
Germany	Research Site	Dortmund
Germany	Research Site	Essen
Germany	Research Site	Freiburg
Germany	Research Site	Muenchen
Germany	Research Site	Wuerzburg
Israel	Research Site	Haifa
Israel	Research Site	Ramat Gan
Italy	Research Site	Bari
Italy	Research Site	Lecce
Italy	Research Site	Meldola
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Napoli
Italy	Research Site	Orbassano
Italy	Research Site	Palermo
Italy	Research Site	Pisa
Italy	Research Site	Ravenna
Italy	Research Site	Rimini
Italy	Research Site	Roma
Italy	Research Site	San Giovanni Rotondo
Italy	Research Site	Torino
Italy	Research Site	Udine
Poland	Research Site	Gdynia
Poland	Research Site	Warszawa
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Burbank	California
United States	Research Site	Dayton	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Fargo	North Dakota
United States	Research Site	LaJolla	California
United States	Research Site	Lubbock	Texas
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Newark	Ohio
United States	Research Site	Palm Springs	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Skokie	Illinois
United States	Research Site	Watertown	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Evaluation of the Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), in adult subjects with relapsed or refractory CLL treated with up to 6 cycles of MEDI-551 in combination with bendamustine versus rituximab in combination with bendamustine.	Study Day 720	No
Secondary	Safety and Tolerability	The safety endpoints include Adverse Events (AEs), Serious Adverse Events (SAEs) occurring during the protocol-specified reporting period and changes in clinical laboratory evaluations, Electrocardiogram (ECGs), vital signs, and weight from baseline.	Study Day 345	Yes
Secondary	Acceptable dose	Determination of an acceptable dose of MEDI-551 in combination with bendamustine; Benefit/Risk Analysis of Safety and Efficacy to be determined	Study Day 56	Yes
Secondary	Anti-tumor Activity	Complete Response (CR) rate, Minimal Residual Disease (MRD) negative CR rate, Time to Response (TTR), Time to Progression (TTP), Progression Free Survival (PFS); Overall Survival (OS)	Study Day 720	No
Secondary	Immunogenicity (IM)	Number and percentage of subjects who develop detectable anti-drug antibodies	Study Day 720	Yes
Secondary	Pharmacokinetics (PK)	Area Under Curve (AUC), Maximum concentration (CMAX), half time (T1-half); clearance (CL).	Study Day 1, Study Day 8, Study Day 15, Study Day 22, Study Day 29, Study Day 57, Study Day 85, Study Day 113, Study Day 141, Study Day 169, Study Day 197, Stduy Day 227, Study Day 255	No
Secondary	Overall Survival	Time from randomization until death due to any cause. OS to be censored on last date known to be alive for subjects either alive at end of study or lost to follow-up.	Study Day 720	No