A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies

Completed · Phase 1/Phase 2

Conditions studied: B-cell Malignancies, Cancer

In brief

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).

Key facts

Study ID

NCT00983619

Run by

MedImmune LLC

People needed

136

Starts

2010-04-16

Expected to finish

2019-03-21

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed CLL, DLBCL, FL, or MM;
• Karnofsky Performance Status >= 70;
• Life expectancy of >= 12 weeks;
• Prior radiation therapy provided exposure does not exceed an area of 25% of marrow space
• Adequate hematological function
• Adequate organ function

You may not qualify if…

• Any available standard line of therapy known to be life-prolonging or life-saving;
• No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for treatment of cancer
• Previous therapy directed against CD19
• Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551;
• History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured;
• Active infection requiring treatment
• Autologous stem cell transplantation within 4 months prior to study entry;
• Allogeneic stem cell transplantation or any other organ transplant;
• Ongoing >= Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria.
• Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551;
• Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted);
• Documented current central nervous system involvement by leukemia or lymphoma;
• Pregnancy or lactation;
• Clinically significant abnormality on ECG.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — La Jolla, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Tampa, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Lake Success, New York, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Morgantown, West Virginia, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Yvoir, Belgium
• Research Site — Montreal, Quebec, Canada
• Research Site — Cona, Italy
• Research Site — Modena, Italy
• Research Site — Madrid, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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