Clinical trial · Interventional
A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open-label investigation to determine whether measurable residual disease (MRD) guided assignment of maintenance therapy is effective in patients with myeloid malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Pre-HCT, patients will undergo usual disease assessments which should include immunophenotypic and/or molecular testing. Based on the results of these tests, patients may or may not be recommended to receive maintenance therapy post-transplant, depending on the presence or absence of a residual malignant clone.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloid Disorders | — | UNRESOLVED | — |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maintenance Therapy | Drug | — | UNRESOLVED |
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MRD positive
- description
- MRD positive patients assigned to Arm A are required to initiate maintenance therapy on this study. Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
- interventionNames
- Drug: Maintenance Therapy
- type
- ACTIVE_COMPARATOR
- label
- MRD negative
- description
- MRD negative patients assigned to Arm B will receive no intervention.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Number of subjects with relapse-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years at time of transplant. * Must have a diagnosis of a myeloid malignancy, myelodysplastic syndrome, myeloproliferative neoplasm (including primary or secondary myelofibrosis), or acute myeloid leukemia or biphenotypic acute leukemia. * Pre-transplant disease assessment must include at least one: * Immunophenotypic assessment by flow for aberrant blasts * NGS to identify persistence of malignant clones using a standard clinically available assay * PCR based measurement of prior identified mutations (if applicable) * Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: None
References
Publications (0)
Data not yet available