A Phase I, Multi-Center, Open-label Study of IMGN529 Administered Intraveneously in Adult Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin
Both
Lymphoma, Non-Hodgkin
Trial Information
A Phase I, Multi-Center, Open-label Study of IMGN529 Administered Intraveneously in Adult Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Inclusion Criteria:
- Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal
zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell
lymphoma (DLBCL), mantle cell lymphoma (MCL).
- Adequate organ function
- ECOG ≤ 2
- Recovered or stabilized from prior treatments.
Exclusion Criteria:
- Allogeneic stem cell transplantation
- Pregnant or lactating females
- Known central nervous system, meningeal or epidural disease including brain
metastases
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Occurrence of dose limiting toxicities
Authority:
United States: Food and Drug Administration
Study ID:
IMGN0301
NCT ID:
NCT01534715
Start Date:
January 2012
Completion Date:
Related Keywords:
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Ohio State University | Columbus, Ohio 43210 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
