NCT03121014

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

A Phase II 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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients will receive the following conditioning regimen: fludarabine 40 mg/m2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2, IV busulfan targeting a 4800μM/min/ day from day -5 through day -2, and ATG (Thymoglobulin®) at 0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1 (Only for recipients of stem cells from unrelated or mismatched donors). In addition to the above conditioning regimen all patients will receive TMI at a dose of 3Gy on days -3, -2 and -1. On day 0, the stem cell product will be infused according to BMT unit policy. Graft versus host disease (GVHD) prophylaxis will consist of administration of tacrolimus and methotrexate (see Section 8). Post-transplant evaluation will be done as per standard care with study data collected at day 30, 60, 90, 180, 365 and 2 years.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-24
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2017-04-19
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study