Clinical trial · Interventional
Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
A Study of a Reduced-Intensity Conditioning Regimen With Treosulfan and Fludarabine for Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic blood or bone marrow transplantation | Procedure | — | UNRESOLVED |
| fludarabine | Drug | Fludarabine | ALIAS |
| treosulfan | Drug | Treosulfan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of Patients Experiencing Regimen-related Toxicity Events in Study Population
- timeFrame
- 34 days and 2 years
- description
- Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal
- measure
- Number of Patients Experiencing Graft Failure
- timeFrame
- 42 days
- description
- Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.
- measure
- Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)
- timeFrame
- 200 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic syndrome
* Any phase allowed, including any of the following:
* Disease in remission
* Relapsed or primary refractory disease
* No CNS leukemic involvement not clearing with prior intrathecal chemotherapy and/or cranial radiotherapy
* Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell transplantation
* Filgrastim (G-CSF) mobilization of bone marrow or stem cells allowed
* Donor available, meeting 1 of the following criteria:
* HLA-identical related donor
* HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA typing
* A single allele mismatch allowed
PATIENT CHARACTERISTICS:
Performance status
* Karnofsky 70-100% OR
* Lansky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* No evidence of synthetic dysfunction
* No severe cirrhosis
* No active infectious hepatitis
Renal
* Creatinine clearance ≥ 50%
* Creatinine ≤ 2 times ULN
* Dialysis independent
Cardiovascular
* No cardiac insufficiency requiring treatment
* No symptomatic coronary artery disease
* Ejection fraction ≥ 35% (for patients with history of cardiac disease or anthracycline exposure)
Pulmonary
* PO\_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR
* PO\_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
* Not requiring supplementary continuous oxygen
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other disease that would severely limit life expectancy
* No HIV positivity
* No active infection requiring deferral of conditioning
* No known hypersensitivity to the study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior allogeneic bone marrow or stem cell transplantation
* No concurrent umbilical cord blood or autologous transplantation
Chemotherapy
* See Disease Characteristics
Radiotherapy
* See Disease Characteristics
Other
* More than 4 weeks since prior experimental drugs
* Concurrent enrollment on another protocol for graft-versus-host disease prophylaxis allowedReferences
Publications (0)
Data not yet available