Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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).

Conditions

Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myeloproliferative Neoplasms, Myelofibrosis, Myelodysplasia, Refractory Anemia, High Risk Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large Cell Non Hodgkins Lymphoma, Lymphoblastic Lymphoma, Burkitt Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Natural Killer Cell Malignancies, Acquired Bone Marrow Failure Syndromes

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Condition
Acute Leukemia
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States, 55337

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

  • * 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.

Ages Eligible for Study

to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Masonic Cancer Center, University of Minnesota,

Punita Grover, MD, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, University of Minnesota

Study Record Dates

2025-11-10