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New treatment option for Acute Myeloid Leukemia, Relapsed, Adult
Official title Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)
ClinicalTrials.gov ID: NCT06802315
What this study is testing
What is Cyclophosphamide (CTX)?
Cyclophosphamide (CTX) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia, relapsed, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 1\. Age 18-65 years.
- 2\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in...
- AML arising from MDS, a myeloproliferative disorder, or secondary AML
- Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
- Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of...
You likely can't join if
- 1\. Presence of significant co-morbidity as shown by:
- 1a. Left ventricular ejection fraction \< 50%
- 2b. Creatinine clearance \<30ml/min.
- 3c. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN.
- 4d. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia.
- 5e. Karnofsky score \<70
See the full eligibility criteria
- 1\. Age 18-65 years.
- 2\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \<5% bone marrow blasts...
- AML arising from MDS, a myeloproliferative disorder, or secondary AML
- Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
- Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary...
- Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (\>3 abnormalities).
- Current or previous INT-2 or high IPSS score.
- Treatment-related MDS.
- MDS diagnosed before the age of 21 years.
- Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.
- Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.
- 1\. Presence of significant co-morbidity as shown by:
- 1a. Left ventricular ejection fraction \< 50%
- 2b. Creatinine clearance \<30ml/min.
- 3c. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN.
- 4d. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia.
- 5e. Karnofsky score \<70
- 6f. Active viral hepatitis or HIV infection.
- 7g. Cirrhosis.
- 2\. Pregnancy or breast feeding
- 3\. Patients unable to sign informed consent.
- 4\. Patients previously received radiation to \>20% of bone marrow-containing areas.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.