Actively Recruiting
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
424 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
M
medac GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
CONDITIONS
Official Title
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute leukemia, chronic myelogenous leukemia (CML) except refractory blast crisis, chronic myelomonocytic leukemia (CMML), myelodysplastic syndromes (MDS), or various lymphomas in complete or partial remission
- Patients with acute leukemia must be in complete morphological remission with less than 5% blasts in bone marrow
- CML patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor if in first chronic phase
- Low grade lymphoma patients must have progressed after two treatment regimens and be in complete or partial remission
- Patients must be at least 6 months old
- Karnofsky score of 70 or higher or ECOG 0-1 for adults; Lansky score 50 or higher for children
- Adequate heart function without severe heart failure or uncontrolled arrhythmia; left ventricular ejection fraction ≥ 40% or shortening fraction > 22%
- Adequate lung function without oxygen need and meeting specific lung test criteria or oxygen saturation ≥ 92% on room air for children unable to do lung tests
- Total bilirubin less than twice the upper limit of normal unless related to Gilbert's disease or hemolysis
- Liver enzymes AST and ALT ≤ 2.5 times upper limit of normal
- Alkaline phosphatase ≤ 5 times upper limit of normal
- Creatinine less than 2.0 mg/dl for adults or estimated creatinine clearance > 40 ml/min for children
- Recent mold infections must be cleared by infectious disease
- Previous allogeneic stem cell transplant allowed if at least 3 months prior or in case of graft failure
- Written informed consent
- Donors must be haploidentical relatives sharing at least 5 out of 10 HLA loci, age 12 or older, weight 40 kg or more, and meet cell therapy donor selection criteria
You will not qualify if you...
- Active, uncontrolled, life-threatening infections requiring treatment at time of transplant conditioning
- Presence of another cancer with less than 75% expected survival at 5 years
- Pregnant or breastfeeding
- Known allergy to treosulfan, fludarabine, or cyclophosphamide
- Use of another investigational agent within 30 days before study entry
- Central nervous system leukemia not cleared by chemotherapy or radiation before conditioning
- Patients with donor-specific anti-HLA antibodies above specified levels unless treated and lowered
- First 10 enrolled patients must be negative for donor-specific antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Filippo Milano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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