A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
NCT02200380 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2017-04-07
Summary
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.
Conditions
- For Donors
- Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling
- For Recipients
- Acute Myelogenous Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Myelodysplastic Syndrome (MDS)
- Chronic Myelogenous Leukemia (CML)
- Non-Hodgkins Lymphoma (NHL)
- Hodgkins Disease (HD)
- Chronic Lymphocytic Leukemia (CLL)
Interventions
- DRUG
-
CDX-301
Related donors will receive CDX-301 for 5 days or 7 days.
- DRUG
-
CDX-301 and plerixafor
Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.
Sponsors & Collaborators
-
Celldex Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-04-13
Countries
- United States
Study Locations
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