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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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

NCT03314974•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

0 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion 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
•Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
+28 more criteria

Exclusion Criteria

•Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II \< 1 year.
•Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \> 3 mg/L, may be considered for this protocol after initial therapy.
•Juvenile myelomonocytic leukemia
•Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR.
•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
+3 more criteria

Locations (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

March 30, 2018

Primary Completion Date

June 10, 2026

Completion Date

June 10, 2027

Last Updated

June 24, 2025

Enrollment

300

ESTIMATED participants

Conditions

Acute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaLymphomaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyeloproliferative NeoplasmsMyelofibrosisMyelodysplasiaRefractory AnemiaHigh Risk AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaProlymphocytic LeukemiaDiffuse Large Cell Non Hodgkins LymphomaLymphoblastic LymphomaBurkitt LymphomaHigh Grade Non-Hodgkin's Lymphoma, AdultMultiple MyelomaJuvenile Myelomonocytic LeukemiaBiphenotypic/Undifferentiated/Prolymphocytic LeukemiasMRD Positive LeukemiaNatural Killer Cell MalignanciesAcquired Bone Marrow Failure Syndromes

Interventions

HSCT with TBI Regimen

BIOLOGICAL

HSCT with Non-TBI Regimen

BIOLOGICAL

Contacts

Tamy Grainger

CONTACT

(612)-273-2800 tgraing1@fairview.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Inclusion Criteria

Exclusion Criteria

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