RECRUITING

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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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

This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

Official Title

Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases

Quick Facts

Study Start:2018-03-30

Study Completion:2025-11-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03314974

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 to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age: ≤ 60 years of age * Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70 * Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian) * Adequate Organ Function: * Renal: Creatinine \<2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR. * Hepatic: Bilirubin, AST, alkaline phosphatase \<4 times the upper limit of institutional normal * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \>95% on room air * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation	* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \> 2 salvage regimens) * CML in blast crisis * Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy. * Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression. * Active central nervous system malignancy * if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \>18 years old prior myeloablative allotransplant or autologous transplant * Active HIV infection or known HIV positive serology * active uncontrolled infection * Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.

Inclusion Criteria

Exclusion Criteria

* Age: ≤ 60 years of age
* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70
* Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)
* Adequate Organ Function:
* Renal: Creatinine \<2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.
* Hepatic: Bilirubin, AST, alkaline phosphatase \<4 times the upper limit of institutional normal
* Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \>95% on room air
* Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation
* HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation

* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \> 2 salvage regimens)
* CML in blast crisis
* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.
* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.
* Active central nervous system malignancy
* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \>18 years old prior myeloablative allotransplant or autologous transplant
* Active HIV infection or known HIV positive serology
* active uncontrolled infection
* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.

Contacts and Locations

Study Contact

Tamy Grainger

CONTACT

(612)-273-2800

tgraing1@fairview.org

Principal Investigator

Punita Grover, MD

PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Study Locations (Sites)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55337

United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Punita Grover, MD, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, 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 Date2018-03-30

Study Completion Date2025-11-10

Study Record Updates