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



Status:Active, not recruiting
Conditions:Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/6/2019
Start Date:April 16, 2010
End Date:March 29, 2019

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A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies

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

To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of MEDI-551 in
subjects with relapsed or refractory advanced B-cell malignancies.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
14
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New Brunswick, New Jersey 08901
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Rochester, MN
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Washington,
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Westwood, KS
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