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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-04-07

No results posted yet for this study

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)

Interventions

DRUG

CDX-301

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

DRUG

CDX-301 and plerixafor

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

Sponsors & Collaborators

  • Celldex Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-03-31
Completion
2016-04-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200380 on ClinicalTrials.gov