Trials / Completed
CompletedNCT01030536
Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)
A Phase 1/2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\]) or CLL.
Detailed description
To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CAT-8015 20 mcg/kg | Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. |
| DRUG | CAT-8015 30 mcg/kg | Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. |
| DRUG | CAT-8015 40 mcg/kg | Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. |
| DRUG | CAT-8015 50 mcg/kg | Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. |
| DRUG | CAT-8015 60 mcg/kg | Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. |
Timeline
- Start date
- 2010-02-15
- Primary completion
- 2013-03-04
- Completion
- 2013-03-04
- First posted
- 2009-12-11
- Last updated
- 2018-04-09
- Results posted
- 2018-04-09
Locations
8 sites across 2 countries: United States, Poland
Source: ClinicalTrials.gov record NCT01030536. Inclusion in this directory is not an endorsement.