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

Masonic Cancer Center, University of Minnesota1 site in 1 country300 target enrollmentMarch 30, 2018

Overview

Phase: Phase 2
Intervention: HSCT with TBI Regimen
Conditions: Acute Leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Enrollment: 300
Locations: 1
Primary Endpoint: Chronic GVHD - 1 year
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 30, 2018

End Date

June 10, 2027

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Masonic Cancer Center, University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

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
•Other Inclusion Criteria:

Exclusion Criteria

•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.