Status:
COMPLETED
A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
Lead Sponsor:
MedImmune LLC
Conditions:
B-cell Malignancies
Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
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 i...
Detailed Description
To determine the MTD or OBD of MEDI-551 in participants with relapsed or refractory advanced B-cell malignancies.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2019
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00983619
Start Date
April 16 2010
End Date
March 21 2019
Last Update
May 13 2020
Active Locations (21)
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1
Research Site
Birmingham, Alabama, United States, 35249
2
Research Site
La Jolla, California, United States, 92093
3
Research Site
Washington D.C., District of Columbia, United States, 20007
4
Research Site
Tampa, Florida, United States, 33612