For DonorsPhase 2NCT02200380

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

A Phase 2 study testing CDX-301 and CDX-301 and plerixafor in people with For Donors and Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, run by Celldex Therapeutics at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, For Recipients
What is being tested?: CDX-301 and CDX-301 and plerixafor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 8 sitesUnited States
Study dates: Jul 2014to 13 Apr 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

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

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)
Being tested: CDX-301, CDX-301 and plerixafor
Medical subject headings: 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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02200380
Study group	Role	What they receive
CDX-301	Experimental	Not described Receives: Drug: CDX-301
CDX-301 and plerixafor	Experimental	Not described Receives: Drug: CDX-301 and plerixafor

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Donor mobilization will be considered successful if ≥ 2 million CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.
Measured: 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).
To describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).
Measured: 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
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.
Measured: 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.
To determine the incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
To determine the incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.
Measured: 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.
To determine the number of post transplant days of hospitalization after receiving hematopoietic cells mobilized with CDX-301 with or without plerixafor.
Measured: 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.
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.
Measured: Day 21, 28, 56, 100, 180, 270, 365.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201413 Apr 2016

First posted25 Jul 2014 (estimated)
Study startJul 2014
Primary completionMar 2016
Study completion13 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for For DonorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200380
Sponsor's protocol ID: CDX301-03
Status last verified: Apr 2017
First submitted: 16 Jun 2014
Last updated: 7 Apr 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
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RecruitingPhase 2
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
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All For Donors trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02200380
Acronym / sponsor ID: CDX301-03
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)
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 36 participants (actual)
Lead sponsor: Celldex TherapeuticsIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Mar 2016 (actual)
Study completion: 13 Apr 2016 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CDX-301	Experimental	Drug: CDX-301
CDX-301 and plerixafor	Experimental	Drug: CDX-301 and plerixafor

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CDX-301Related donors will receive CDX-301 for 5 days or 7 days.	Drug	CDX-301
CDX-301 and plerixaforRelated donors will receive CDX-301 for 5 or 7 days plus plerixafor.	Drug	CDX-301 and plerixafor

Primary outcome

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.

9 secondary outcomes

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
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
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.
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.
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.
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.
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.
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
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.

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.

Related trials for For Donors

RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
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RecruitingPhase 2
Romiplostim for Platelet Engraftment After Haploidentical or Matched Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplantation
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RecruitingObservational study
HPC Offered for PRESERVE Expansion
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors. (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.