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New treatment option for Acute Myelogenous Leukemia
Official title Cord Blood Transplantation in Children and Young Adults With Blood Cancer
ClinicalTrials.gov ID: NCT07566377
What this study is testing
What is Cord Blood Units?
Cord Blood Units is an investigational medicine, being studied as a potential treatment for acute myelogenous leukemia.
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 purpose of this study is to find out whether Cord Blood Transplantation/CBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.
- 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 up to 26
You may be able to join if
- A patient cannot be considered eligible for this study unless ALL of the following conditions are met. ° Disease type Cohort 1, High Risk Disease...
- Complete first remission (CR1) with blast count \< 5% by bone marrow morphology at high risk for relapse such as any of the following:
- Known prior diagnosis of myelodysplasia (MDS)
- High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and/or high-risk molecular abnormalities (e.g...
- Requirement for 2 or more inductions to achieve CR1
You likely can't join if
- Exclusion criteria for both cohorts: ° Inadequate performance status/ organ function. ° Active CNS leukemic involvement.
- Chloroma \>2 cm.
- Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.
- HIV infection.
- Seropositivity for HTLV-1.
- Pregnancy or breast feeding.
See the full eligibility criteria
Who can join
- A patient cannot be considered eligible for this study unless ALL of the following conditions are met. ° Disease type Cohort 1, High Risk Disease: Patients with age ≤ 26 years at the time of informed consent with no...
- Complete first remission (CR1) with blast count \< 5% by bone marrow morphology at high risk for relapse such as any of the following:
- Known prior diagnosis of myelodysplasia (MDS)
- High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and/or high-risk molecular abnormalities (e.g., TP53)
- Requirement for 2 or more inductions to achieve CR1
- Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and/or gene therapy or cell therapy)
- Presence of Minimal/Measurable Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods (at End of Induction or End of Consolidation)
- Other high-risk features not defined above.
- Complete second remission (CR2) or subsequent remission, with blast count \< 5% by bone marrow morphology
- Presence of MRD by multiparameter flow cytometry at pre-transplant evaluation is acceptable. II. Acute lymphoblastic leukemia (ALL):
- Complete first remission (CR1) with MRD negative status by multicolor flow cytometry, 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, KMT2A (11q23) or other high risk molecular abnormality
- Failure to achieve complete remission (CR) after four weeks of induction therapy (transplant to follow antibody therapy and/or CAR T cells)
- Persistence or recurrence of MRD on therapy (Transplant to follow antibody therapy and/or CAR T cells)
- T-ALL in CR even with presence of MRD
- Other high-risk features not defined above
- Complete second remission (CR2) or subsequent remission with MRD negative status by multiparameter flow cytometry.
- Relapse in less than 36 months from CR1
- Relapse for T-ALL
- Patients after antibody therapy (e.g., blinatumomab, inotuzumab, other) and/or CAR-T cell therapy that resulted in MRD negative status by multiparameter flow cytometry. III. Other acute leukemias:
- Leukemias of ambiguous lineage or of other types with \< 5% blasts by bone marrow morphology.
- Patients with persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in \< 5% of cells.
- Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase.
- Any leukemia that developed after gene therapy or cell therapy IV. Myelodysplastic Syndrome (MDS):
- Any IPSS risk category with life-threatening cytopenia(s).
- Any IPSS risk category with high risk cytogenetic/molecular findings (5, 7, 8, complex karyotype, or TP53) V. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high risk of relapse or progression if not in...
- Patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell NHL) in CR.
- Patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease/ CR/ PR with no single lesion equal to or more...
- Patients with HL without progression of disease (POD) after salvage chemotherapy with no single lesion ≥5 cm. Cohort 2: Very High-Risk disease:
- Patients in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. The second transplant will take place at least 4 months after the first.
- Acute myelogenous leukemia (AML) or Myelodysplastic Syndrome (MDS): Relapse after previous transplant, in CR after induction therapy. MRD positive status by multi-parameter flow cytometry is accepted.
- Acute lymphoblastic leukemia (ALL): Relapse after previous transplant, in CR after induction therapy and/or antibody therapy/CAR T cells. MRD positive status after targeted therapy, as evaluated by multi-parameter flow...
- Other: patients with leukemia or lymphoma, who, in the opinion of their physician, are not likely to have reduction in disease burden with further chemotherapy.
- Patients with relapsed/refractory disease at either first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology. ° Relapse after previous transplant with \<...
- Bilirubin ≤ 1.5 mg/dL (unless benign congenital hyperbilirubinemia).
- ALT ≤ 3 x upper limit of normal.
- Pulmonary function (FVC, FEV1 and DLCO corrected for hemoglobin) ≥ 50% predicted.
- In young children unable to perform pulmonary function testing: pulse oximetry \>92% in room air, and a normal CT of the chest (if CT is not normal, the child needs to be evaluated and cleared by pediatric pulmonary...
- Left ventricular ejection fraction \> 50%.
- Age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) ≤ 7.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study.
- Renal: Serum creatinine (SCr) ≤ 1.5 x normal for age. If SCr is outside the normal range, then CrCl \> 50 mL/min (calculated or estimated) or estimated GFR (mL/min/1.73m2) \>30% of predicted normal for age. Normal GFR...
What rules you out
- Exclusion criteria for both cohorts: ° Inadequate performance status/ organ function. ° Active CNS leukemic involvement.
- Chloroma \>2 cm.
- Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.
- HIV infection.
- Seropositivity for HTLV-1.
- 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.
- Any abnormal condition or lab result that is considered by the PI capable or altering patient's condition or study outcome. Cohort 2 Very High-Risk Disease (additional to above): ° Allogeneic HCT in the preceding 4...
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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, up to 26 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.