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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

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ClinicalTrials.gov Identifier: NCT02200380
Recruitment Status : Terminated
First Posted : July 25, 2014
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.

Condition or disease Intervention/treatment Phase
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) Drug: CDX-301 Drug: CDX-301 and plerixafor Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of CDX-301 (rhuFlt3L) With or Without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA-Matched Donor/Recipient Sibling Pairs
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 13, 2016


Arm Intervention/treatment
Experimental: CDX-301 Drug: CDX-301
Related donors will receive CDX-301 for 5 days or 7 days.

Experimental: CDX-301 and plerixafor Drug: CDX-301 and plerixafor
Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.




Primary Outcome Measures :
  1. Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors. [ Time Frame: 1 Year ]
    Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting.


Secondary Outcome Measures :
  1. The proportion of donors whose stem cells can be successfully mobilized and collected with a sufficient CD34+ cell count using CDX-301 with or without plerixafor as the mobilizing agent. [ Time Frame: Day 6 - Day 12 ]
    Donor mobilization will be considered successful if ≥ 2 million CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.

  2. Describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells). [ Time Frame: Day 6 - Day 12 ]
    To describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).

  3. Incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor [ Time Frame: Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. ]
    To determine the incidence of and kinetics of neutrophil, and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.

  4. Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX301-03 with or without plerixafor. [ Time Frame: Day 28, Day 100, Day 180, Day 365. ]
    To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.

  5. Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. [ Time Frame: Day 28, 100, 180, 365. ]
    To assess the rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.

  6. Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. [ Time Frame: Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. ]
    To determine the incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.

  7. Incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients. [ Time Frame: Day 28, Day 56, Day 100, Day 180, Day 270, Day 365. ]
    To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.

  8. Number of post-transplant days of hospitalization in patients that received hematopoietic cells mobilized with CDX-301 with or without plerixafor. [ Time Frame: Day 21, 28, 56, 100, 180, 270, 365 ]
    To determine the number of post transplant days of hospitalization after receiving hematopoietic cells mobilized with CDX-301 with or without plerixafor.

  9. Incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor. [ Time Frame: Day 21, 28, 56, 100, 180, 270, 365. ]
    To determine the incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200380


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Georgia
Emory University-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana Blood and Marrow Transplant
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, United States, 43210
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Celldex Therapeutics

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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02200380     History of Changes
Other Study ID Numbers: CDX301-03
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Leukemia
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents