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New treatment option for Acute Myelogenous Leukemia (AML)
Official title Cord Blood Transplant in Adults With Blood Cancers
ClinicalTrials.gov ID: NCT05884333
What this study is testing
What is Conditioning Chemotherapy?
Conditioning Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myelogenous leukemia (aml).
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
- Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard ("optimized") practice for cord blood transplant (CBT).
- 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 21 to 65
You may be able to join if
- I. Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse such as any of the following:
- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).
- Therapy-related AML.
- Presence of extramedullary leukemia at diagnosis.
You likely can't join if
- Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.
- Patients with persistent with CNS involvement in CSF or CNS disease at time of screening
- Prior checkpoint inhibitors/ blockade in the last 12 months.
- Two prior stem cell transplants of any kind.
- One prior autologous stem cell transplant within the preceding 12 months.
- Prior allogeneic transplantation.
See the full eligibility criteria
- I. Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse such as any of the following:
- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).
- Therapy-related AML.
- Presence of extramedullary leukemia at diagnosis.
- Requirement for 2 or more inductions to achieve CR1.
- Intermediate or high ELN2017 genetic risk AML.
- Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.
- Other high-risk features not defined above.
- Complete second remission (CR2) or greater (CR2+).
- Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible II. Acute lymphoblastic leukemia (ALL):
- Complete first remission (CR1) at high risk for relapse such as any of the following:
- Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
- Failure to achieve MRD- complete remission after induction therapy.
- Persistence or recurrence of minimal residual disease on therapy.
- Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician.
- Other high-risk features not defined above.
- Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible. III. Other acute leukemias...
- International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis.
- Any IPSS risk category if life-threatening cytopenia(s) exists.
- Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia.
- MDS/MPD overlap syndromes without myelofibrosis.
- MDS/ MPD patients must have less than 10% bone marrow myeloblasts and ANC \> 0.2 (growth factor supported if necessary) at transplant work-up. V. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not...
- Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).
- Calculated creatinine clearance \> 70 ml/min.
- Bilirubin \< 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
- ALT \< 3 x upper limit of normal (ULN).
- Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \> 60% predicted.
- Left ventricular ejection fraction (MOD-bp)\> 50%.
- Albumin \> 3.0.
- Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5. Graft criteria: Two CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient...
- Each CB unit must be at least 3/8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. [Taken from the Cord Blood Summary]
- Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\^7 TNC/ recipient body weight (TNC/ kg). [Taken from the Cord Blood Summary]
- Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\^5 CD34+ cells/ recipient body weight (CD34+ cells/kg). [Taken from the Cord Blood Summary]
- A minimum of one unit will be reserved as a backup graft. [Taken from the Cord Blood Summary]
- Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml/s per unit or per bag if unit in two bags) and be red blood cell depleted. [Taken from the Cord Blood Summary]
- Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.
- Patients with persistent with CNS involvement in CSF or CNS disease at time of screening
- Prior checkpoint inhibitors/ blockade in the last 12 months.
- Two prior stem cell transplants of any kind.
- One prior autologous stem cell transplant within the preceding 12 months.
- Prior allogeneic transplantation.
- Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology.
- Active and uncontrolled infection at time of transplantation.
- HIV infection.
- Seropositivity for HTLV-1.
- Inadequate performance status/ organ function.
- Pregnancy or breast feeding.
- Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.