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
NCT ID: NCT02200380
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
36 participants
INTERVENTIONAL
2014-07-31
2016-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CDX-301
CDX-301
Related donors will receive CDX-301 for 5 days or 7 days.
CDX-301 and plerixafor
CDX-301 and plerixafor
Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.
Interventions
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CDX-301
Related donors will receive CDX-301 for 5 days or 7 days.
CDX-301 and plerixafor
Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CDX301-03
Identifier Type: -
Identifier Source: org_study_id
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