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

NCT02200380 | Terminated Phase 2

• 1 other identifier: CDX301-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.

  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 Outcomes (9)

• 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.

  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).

  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

  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.

  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.

  Day 28, 100, 180, 365.

Study Arms (2)

CDX-301

EXPERIMENTAL

Drug: CDX-301

CDX-301 and plerixafor

EXPERIMENTAL

Drug: CDX-301 and plerixafor

Interventions

CDX-301 DRUG

Related donors will receive CDX-301 for 5 days or 7 days.

CDX-301

CDX-301 and plerixafor DRUG

Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.

CDX-301 and plerixafor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donors:
• Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
• 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
• 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)

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

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (8)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Emory University-Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Indiana Blood and Marrow Transplant

Indianapolis, Indiana, 46237, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Columbus, Ohio, 43210, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Non-Hodgkin; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Leukemia, B-Cell

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 13, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

US (8)