Allo HSCT for High Risk Hemoglobinopathies

Description

A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.

Conditions

Graft Failure, Sickle Cell Disease, Hemoglobinopathies

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Study Overview

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Study Details

Study overview

A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.

Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

Allo HSCT for High Risk Hemoglobinopathies

Condition
Graft Failure
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Masonic Cancer Center, Minneapolis, Minnesota, United States, 55455

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Sickle Cell Disease (SCD)
  • * SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents/patient must be counseled as to the risks and benefits and provide their voluntary informed consent
  • * Transfusion Dependent Alpha- or Beta- Thalassemia
  • * Diamond Blackfan Anemia
  • * Other Non-Malignant Hematologic Disorders
  • * Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.
  • * Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.
  • * Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment
  • * HIV Positive
  • * Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
  • * Known allergy to any of the study components
  • * Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
  • * Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study

Ages Eligible for Study

to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Masonic Cancer Center, University of Minnesota,

Study Record Dates

2032-06-01