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Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

NCT03121014 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-01-13

No results posted yet for this study

Summary

The study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).

Conditions

Interventions

DRUG

Fludarabine

40 mg/m\^2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2

DRUG

Busulfan

targeting a 4800μM/min/ day from day -5 through day -2

DRUG

ATG

0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1

RADIATION

Total Marrow Irradiation

dose of 3Gy on days -3, -2 and -1

PROCEDURE

Stem Cell Product Infusion

Day 0 according to BMT unit policy

DRUG

Tacrolimus

The starting dose is at 0.03 mg/kg/day IV continuous infusion over 24 hr from 4 PM on day -2. Dose will be adjusted to target trough levels of 5-15 ng/mL. More information is available in the protocol document.

DRUG

Methotrexate

5mg/m\^2 on Day 1, 5 mg/m\^2 on Days 3, 6 and 11

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Damiano Rondelli, MD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03121014 on ClinicalTrials.gov