RECRUITING

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Conditions

Primary Graft Failure Secondary Graft Failure Hematopoietic stem cell transplant

Quick Navigation

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

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure. The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.

Official Title

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Quick Facts

Study Start:2014-10-06

Study Completion:2032-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02161783

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 Criteria	Exclusion Criteria
* Patients with primary or secondary graft failure, as defined below, may receive a second transplant: * Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant. * Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery. * Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. * Recipients should have acceptable organ function defined as: * Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. * Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal * Cardiac: left ventricular ejection fraction \> 40%	* Uncontrolled infection at the time of transplant. * Patients with Fanconi Anemia or other DNA breakage syndromes.

Inclusion Criteria

Exclusion Criteria

* Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
* Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant.
* Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery.
* Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
* Recipients should have acceptable organ function defined as:
* Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
* Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal
* Cardiac: left ventricular ejection fraction \> 40%

* Uncontrolled infection at the time of transplant.
* Patients with Fanconi Anemia or other DNA breakage syndromes.

Contacts and Locations

Study Contact

Timothy Krepski

CONTACT

612-273-2800

tkrepsk1@fairview.org

Principal Investigator

Troy C Lund, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Troy C Lund, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

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 Date2014-10-06

Study Completion Date2032-01-30

Study Record Updates

Study Start Date2014-10-06

Study Completion Date2032-01-30

Terms related to this study

Keywords Provided by Researchers

Hematopoietic stem cell transplant

Additional Relevant MeSH Terms

Primary Graft Failure
Secondary Graft Failure