Actively Recruiting

Phase Not Applicable
All Genders
NCT06803745

Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-06

160

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.

CONDITIONS

Official Title

Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 years or older
  • Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute lymphoblastic lymphoma, or acute leukemia of mixed or ambiguous lineage with less than 5% blasts in bone marrow
  • Patients with prior myeloproliferative neoplasm, myelodysplastic syndrome, or related conditions if treated with specific therapies
  • No active extramedullary leukemia or active central nervous system involvement
  • Presence of a related or unrelated donor matched or mismatched according to HLA criteria
  • Planned allogeneic bone marrow transplant using post-transplant cyclophosphamide for graft-versus-host disease prevention
  • Adequate heart, liver, and lung function as defined by specific clinical measures
  • Patients may participate in other transplant-related trials or receive standard post-transplant maintenance therapies
Not Eligible

You will not qualify if you...

  • Acute leukemia with promyelocytic leukemia (PML)/retinoic acid receptor alpha (RARA) fusion
  • Documented diagnosis of myeloproliferative neoplasm, myelodysplastic syndrome, or overlap syndrome prior to acute leukemia diagnosis (except AML with myelodysplastic features without such history)
  • Prior allogeneic blood or marrow transplant
  • Poor performance status (ECOG > 2 or Karnofsky/Lansky score < 60)
  • Active additional malignancy with life expectancy less than 2 years
  • Symptomatic coronary artery disease
  • Uncontrolled infection
  • Pregnant or breastfeeding
  • Body mass index greater than 45 kg/m2

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

J

Jonathan Webster, MD

CONTACT

P

Preston Clairborne, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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