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

NCT ID: NCT00983619

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-16
• Study Completion Date: 2019-03-21

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 if not reached, at optimal biologic dose (OBD).

Detailed Description

To determine the MTD or OBD of MEDI-551 in participants with relapsed or refractory advanced B-cell malignancies.

Conditions

B-cell Malignancies; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

MEDI-551

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medimmune Inc. Clinical Development

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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

Countries

United States; Belgium; Canada; Italy; Spain

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

Click here and search for drug information provided by the FDA.

https://www.clinicaltrials.gov/

Click here to find results for studies related to marketed products.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=MI-CP204&attachmentIdentifier=316ce04f-0e5f-406f-b2be-42b8ce6ae595&fileName=CP204_SAP_v4_Final_Redacted.pdf&versionIdentifier=

Statistical Analysis Plan (SAP)

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=MI-CP204&attachmentIdentifier=e262f497-135c-41f5-829e-6723fdd242de&fileName=study-protocol-mi-cp204-v13_final_Redacted.pdf&versionIdentifier=

MI-CP204 redacted CSP

Other Identifiers

2009-016378-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MI-CP204

Identifier Type: -

Identifier Source: org_study_id