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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD positive | Active Comparator | 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. |
|
| MRD negative | Active Comparator | MRD negative patients assigned to Arm B will receive no intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance Therapy | Drug | Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with relapse-free survival | All patients will have standard histological analysis of bone marrow biopsies done post-transplant after engraftment, per institutional standard, at one year. For acute leukemia (AML or ALL) or myelodysplastic syndrome, relapse is defined as greater than 5% blasts on histologic analysis of bone marrow biopsy. Among patients assigned to Arm B, institution of any therapy with intent to treat hematologic malignancy will also be considered evidence of relapse. | One Year |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical College of Wisconsin Cancer Center Clinical Trials Office | Contact | 866-680-0505 | 8900 | cccto@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sameem Abedin, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| No intervention | Other | Patients will receive no maintenance therapy. |
|
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D015470 | Leukemia, Myeloid, Acute |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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