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New treatment option for Acute Leukemia
Official title BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
ClinicalTrials.gov ID: NCT04187105
What this study is testing
What is Conditioning regimen with half-matched (haploidentical) stem cell transplant?
Conditioning regimen with half-matched (haploidentical) stem cell transplant is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute leukemia.
Also referred to as Fludarabine.
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
- This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).
- 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 75
You may be able to join if
- Patient age 18-75 years
- Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.
- Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw...
- Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included...
- Eligible diagnoses are listed below. Patient must have one of the following:
You likely can't join if
- Presence of significant co morbidity as shown by:
- a. Left ventricular ejection fraction \< 40%
- b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
- c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
- d. Karnofsky score \<70
- e. History of cirrhosis
See the full eligibility criteria
- Patient age 18-75 years
- Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor.
- Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw...
- Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches.
- Eligible diagnoses are listed below. Patient must have one of the following:
- Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia).
- Poor-risk AML in first remission:
- AML arising from MDS or a myeloproliferative disorder, or secondary AML
- Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation.
- 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
- Poor risk ALL in first remission:
- Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)/near triploidy (60-78 chromosomes)
- Philadelphia-like ALL
- Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL
- Age\>35
- Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry
- Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features:
- i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics)
- ii. IPSS score of INT-2 or greater
- iii. Treatment-related or Secondary MDS
- iv. MDS diagnosed before age 21 years
- v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy
- vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions
- vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations
- Mixed lineage and biphenotypic leukemia
- Adequate end-organ function as measured by:
- a. Left ventricular ejection fraction ≥ 40%
- b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN
- c. FEV1 and FVC \> 50% of predicted
- Presence of significant co morbidity as shown by:
- a. Left ventricular ejection fraction \< 40%
- b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN
- c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia
- d. Karnofsky score \<70
- e. History of cirrhosis
- Patients unable to sign informed consent
- Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)
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 75 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.