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
Stopped early · Phase 2
Conditions studied: 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)
In brief
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.
Key facts
- Study ID
- NCT02200380
- Run by
- Celldex Therapeutics
- People needed
- 36
- Starts
- 2014-07-01
- Expected to finish
- 2016-04-13
- Last updated by the study team
- 2017-04-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Donors:
- Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
- 6 out of 6 HLA-matched sibling
- Negative test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
- Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures
- Subjects should be in generally good health and without significant medical conditions, based upon pre-study medical history, physical examination, electrocardiogram (ECG), chest X- ray, and laboratory tests
- Meets all criteria to serve as a mobilized blood cell donor in accordance with all applicable individual Transplant Center criteria
- Recipient:
- Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
- 6 out of 6 HLA-matched sibling
- Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures
- Diagnosis of one of following:
- Acute Myelogenous Leukemia (AML) in 1st remission or beyond
- Acute Lymphoblastic Leukemia (ALL) in 1st remission or beyond
- Chronic Myelogenous Leukemia (CML)
- Chronic Lymphoblastic Leukemia (CLL), relapsing after at least one prior regimen
- Myelodysplastic Syndrome (MDS), either intermediate 1,2, or high risk by IPI Scoring System or transfusion dependent
- Non-Hodgkins Lymphoma (NHL) or Hodgkins Disease (HD) in 2nd or greater complete remission, partial remission, or in relapse
- Meets all criteria to serve as a transplant recipient in accordance with all applicable individual Transplant Center criteria
You may not qualify if…
- Donors:
- Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- Prior treatment with any rhuFlt3L product
- Any vaccination within 4 weeks prior to CDX-301 dosing
- Donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to CDX-301 dosing
- Any experimental treatment within 4 weeks prior to CDX-301 dosing
- Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months prior to CDX-301 dosing.
- History of first degree relatives with primary or secondary immunodeficiency to include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or psoriasis
- History of tuberculosis infection
- Herpes zoster within 3 months prior to starting study drug
- Pregnant or nursing
- Recipient:
- Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- Prior allogeneic transplant
- More than one prior autologous transplant
- Prior treatment with any rhuFlt3L product
- Any vaccination within 4 weeks prior to transplant
- Uncontrolled infection at the time of the transplant conditioning regimen
- Pregnant or nursing
- Any condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the study outcome
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Emory University-Winship Cancer Institute — Atlanta, Georgia, United States
- Indiana Blood and Marrow Transplant — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
- Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute — Columbus, Ohio, United States
- University of Virginia Medical Center — Charlottesville, Virginia, United States
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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