RECRUITING

A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition

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Conditions

Primary Immune Regulatory DisorderAutoimmune LymphoproliferativeImmune System DiseasesStem Cell TransplantEmapalumabFludarabineDexamethasone23-040

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are doing this study to find out whether emapalumab or a combination of fludarabine and dexamethasone are effective in preparing people with a primary immune regulatory disorder (PIRD) and/or an autoinflammatory condition to receive a stem cell transplant. The researchers will look at how well the study treatments reduce inflammation and aid in the engraftment process (the process of donated stem cells traveling to the bone marrow, where they begin to make new immune cells. "Funding Source - FDA OOPD"

Official Title

Phase 2 Study BRIDGING PRE-TRANSPLANT INFLAMMATORY DAMPENING for PRIMARY IMMUNE REGULATORY DISORDERS (BRIDGE Trial)

Quick Facts

Study Start:2023-03-15
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05787574

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients receiving first allo-HCT for the following immunologic conditions:
  2. * Primary Immune Regulatory Disorder with or without a genetic lesion as defined by the Primary Immune Deficiency Treatment Consortium (PIDTC)
  3. * Patients with autoinflammatory disorders evidenced by cytokine or inflammation assays with at least 1.5x ULN of measured cytokines and/or an elevated ferritin or ESR \> 2 ULN
  4. * For inclusion on the emapalumab group, the lesion must be isolated to the IFNγ pathway (or mediators thereof) with an elevated CXCL9 \>1.5 ULN OR sIL2R \>1.5 ULN (or already controlled on immune modulation, provided that CXCL9 or sIL2R levels were elevated prior to initiation of immune modulation). Inclusion on the Fludarabine/dexamethasone group requires inflammation (as defined above) other than an isolated IFNγ pathway
  5. * Able to tolerate cytoreduction (based on adequate organ function as described below)
  6. * Patients of any age can enroll so long as they meet other
  1. * Uncontrolled infection at the time of enrollment.
  2. * Patients who have undergone previous allo-HCT.
  3. * Patient seropositivity for HIV I/II and/or HTLV I/II.
  4. * Females who are pregnant or breastfeeding.
  5. * Patients unwilling to use contraception during the study period.
  6. * Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.

Contacts and Locations

Study Contact

Joseph Oved, MD
CONTACT
646-888-3314
ovedj@mskcc.org
Roni Tamari, MD
CONTACT
646-608-3738

Principal Investigator

Joseph Oved, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

University of California, San Francisco (Data collection only)
San Francisco, California, 94143
United States
Children's Healthcare of Atlanta (Data Collection Only)
Atlanta, Georgia, 30322
United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
United States
Texas Children's Hospital (Data Collection)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Joseph Oved, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2023-03-15
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Stem Cell Transplant
  • Emapalumab
  • Fludarabine
  • Dexamethasone
  • 23-040

Additional Relevant MeSH Terms

  • Primary Immune Regulatory Disorder
  • Autoimmune Lymphoproliferative
  • Immune System Diseases