Clinical trial NCT01957579: A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Official title: A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Cancer
Advanced B Cell Malignancies
Keywords: Phase I
advanced
B cell malignancies
dose escalation
CD19
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2013-10-08
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.


Eligibility criteria: Inclusion Criteria:

* Japanese men or women at least 20 years of age
* Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
* Karnofsky Performance Status ≥70;
* Life expectancy of ≥12 weeks

Exclusion Criteria:

* Any available standard line of therapy known to be life-prolonging or life-saving
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
* Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From baseline to 30 days after the last dose of study drug
Secondary outcomes:
measure: Number of Participants With Dose Limiting Toxicities
timeFrame: From baseline to 28 days after the first dose of study drug
measure: Maximum Tolerated Dose
timeFrame: From baseline to 28 days after the first dose of study drug
measure: MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)
timeFrame: Day 0 (pre-dose)
measure: MEDI-551 Trough Concentration Levels at Day 7
timeFrame: Day 7
measure: MEDI-551 Trough Concentration Levels at Day 28
timeFrame: Day 28
measure: MEDI-551 Trough Concentration Levels at Day 56
timeFrame: Day 56
measure: MEDI-551 Trough Concentration Levels at Day84
timeFrame: Day 84
measure: MEDI-551 Trough Concentration Levels at Day 112
timeFrame: Day 112
measure: MEDI-551 Trough Concentration Levels at Day 140
timeFrame: Day 140
measure: MEDI-551 Trough Concentration Levels at Day 168
timeFrame: Day 168
measure: Anti-MEDI-551 Antibodies
timeFrame: From baseline to 30 days after the last dose of study drug
measure: Number of Participants With Tumour Response in FL Patients
timeFrame: From the baseline to 30 days after the last dose of study drug
measure: Number of Participants With Tumour Response in DLBCL Patients
timeFrame: From the baseline to 30 days after the last dose of study drug
measure: Number of Participants With Tumour Response in CLL Patients
timeFrame: From the baseline to 30 days after the last dose of study drug
measure: Number of Participants With Tumour Response in MM Patients
timeFrame: From the baseline to30 days after the last dose of study drug
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Isehara-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
Study officials:
References: