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

April 6, 2017 updated by: Celldex Therapeutics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 6 - Day 12
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).
Day 6 - Day 12
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.
Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
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.
Day 28, Day 100, Day 180, Day 365.
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.
Day 28, 100, 180, 365.
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.
Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
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.
Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.
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.
Day 21, 28, 56, 100, 180, 270, 365
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.
Day 21, 28, 56, 100, 180, 270, 365.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

April 13, 2016

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (ESTIMATE)

July 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX301-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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