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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
A Clinical Study using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
Study identifier:MI-CP204
ClinicalTrials.gov identifier:NCT00983619
EudraCT identifier:2009-016378-34
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
B-cell Malignancies
Phase
Phase 1/2
Healthy volunteers
No
Study drug
MEDI-551, Rituximab
Sex
All
Actual Enrollment
136
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 16 Apr 2010
Primary Completion Date: 21 Mar 2019
Study Completion Date: 21 Mar 2019
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Washington, DC, United States, 20007
Location
Research Site
Tampa, FL, United States, 33612
Location
Research Site
Birmingham, AL, United States, 35249
Location
Research Site
Morgantown, WV, United States, 26506
Location
Research Site
Yvoir, Belgium, 5530
Location
Research Site
Leuven, Belgium, 3000
Location
Research Site
Houston, TX, United States, 77030
Location
Research Site
Montreal, QC, Canada, H3T 1E2
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A-MEDI-551 0.5 mg/kg Participants will receive intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part A-MEDI-551 1 mg/kg Participants will receive IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part A-MEDI-551 2 mg/kg Participants will receive IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part A-MEDI-551 4 mg/kg Participants will receive IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part A-MEDI-551 8 mg/kg Participants will receive IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part A-MEDI-551 12 mg/kg Participants will receive IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part B-MEDI-551 6 mg/kg Participants will receive IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part B-MEDI-551 12 mg/kg Participants will receive IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part B-MEDI-551 24 mg/kg Participants will receive IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
| Experimental: Part C-MEDI-551 8 mg/kg + rituximab Participants will receive IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg will be administered on Day 1 of each 28-day cycle. The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. Drug: Rituximab Rituximab will be administered IV on Days 1, 8, 15, and 22 (28- day cycle). The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent. |
| Experimental: Part C-MEDI-551 12 mg/kg + rituximab Participants will receive IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg will be administered on Day 1 of each 28-day cycle. The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. Drug: Rituximab Rituximab will be administered IV on Days 1, 8, 15, and 22 (28- day cycle). The treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches complete response or withdraws consent. |
| Experimental: Part D-MEDI-551 12 mg/kg Participants will receive IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment will be continued until the participants experiences unacceptable toxicity, disease progression, reaches CR or withdraws consent. | Drug: MEDI-551 MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed. |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
Medimmune Inc. Clinical Development
Medimmune Inc.
