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Status:

TERMINATED

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

Lead Sponsor:

Celldex Therapeutics

Conditions:

For Donors

Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief 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). HL...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 13 2016

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT02200380

Start Date

July 1 2014

End Date

April 13 2016

Last Update

April 7 2017

Active Locations (8)

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Page 1 of 2 (8 locations)

1

UCLA Medical Center

Los Angeles, California, United States, 90095

2

Emory University-Winship Cancer Institute

Atlanta, Georgia, United States, 30322

3

Indiana Blood and Marrow Transplant

Indianapolis, Indiana, United States, 46237

4

University of Iowa

Iowa City, Iowa, United States, 52242