BridgeMD
New treatment option for aGVHD
Official title Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
ClinicalTrials.gov ID: NCT06904482
What this study is testing
What is Haplo-Identical / Cord Blood Transplant?
Haplo-Identical / Cord Blood Transplant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for agvhd.
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 see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.
- 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 and older
You may be able to join if
- Participants with the following hematologic malignancies:
- Acute myelogenous leukemia (AML): High-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia (MDS))
- Treatment-related
- Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations...
You likely can't join if
- Participants with inadequate Organ Function as defined by:
- Creatinine clearance \< 40ml/min (Cockcroft-Gault)
- Bilirubin \> 2X institutional upper limit of normal unless Gilbert syndrome
- AST (SGOT) \> 3X institutional upper limit of normal
- ALT (SGPT) \> 3X institutional upper limit of normal
- Pulmonary function: DLCOc \< 60%
See the full eligibility criteria
- Participants with the following hematologic malignancies:
- Acute myelogenous leukemia (AML): High-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia (MDS))
- Treatment-related
- Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)
- Participants must be in CR1, CR2, CR3 or CRi
- Acute lymphoblastic leukemia (ALL)
- High-risk CR1 including:
- Poor-risk cytogenetics (e.g., t(9;22)or 11q23 rearrangements)
- Presence of minimal disease by flow cytometry or PCR or Clonoseq after 2 or more cycles of chemotherapy
- No CR within 4 weeks of initial treatment
- Participants in CR2 or beyond
- Participants must be in CR1, CR2, CR3, or CRi
- Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R) or treatment related MDS
- High-risk lymphoma
- Age \> 18 years
- Participants without a suitable HLA-matched related or unrelated donor CASE9Z24 Page 17 Version dated 12.16.2025
- Participants with the following suitable grafts:
- A 4-8/8 HLA high resolution matched cord blood unit with a cell dose of 1.0x105 CD34 cells/kg.
- A haplo-identical donor with a goal cell dose of \> 4.0x106 CD34cells/kg (minimum 2 x106 CD34 cells/kg)
- Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia including standard intrathecal chemotherapy and/or radiation therapy will be...
- Participants must have the ability to understand and the willingness to sign a written informed consent document
- Participants with inadequate Organ Function as defined by:
- Creatinine clearance \< 40ml/min (Cockcroft-Gault)
- Bilirubin \> 2X institutional upper limit of normal unless Gilbert syndrome
- AST (SGOT) \> 3X institutional upper limit of normal
- ALT (SGPT) \> 3X institutional upper limit of normal
- Pulmonary function: DLCOc \< 60%
- Cardiac: left ventricular ejection fraction \< 40%
- ECOG \<2
- Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the...
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
- Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, 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.