Ongoing interventional trials using MRD-directed therapies
| Sponsor/trial . | Identifier . | Phase . | Estimated N of participants . | Patient age, y . | Clinical notes . | MRD assessment . | MRD+ intervention . | Expected completion . |
|---|---|---|---|---|---|---|---|---|
| Cardiff University; UK MRC AML 18 | NCT02272478 | 3 | 1600 | >60 | Older patients with primary or secondary AML or high-risk MDS; DA or DA + GO induction | Postinduction, flow cytometry based | MRD+ patients randomized to DA, DA + cladaribine, or FLAG-Ida | October 2020 |
| Hospital La Fe, Spain; PETHEMA-LMA 10 | NCT01296178 | 3 | 200 | <65 | Primary or secondary, treatment-naïve, non-APL AML patients; cytarabine + Ida induction | Flow cytometry and molecular based | Risk-adapted, MRD-directed therapy, not specified | December 2018 |
| Various sites in Germany; RELAZA2 | NCT01462578 | 2 | 93 | >18 | AML or MDS patients with detectable molecular markers after chemotherapy or allo-SCT | Patient-specific molecular markers [eg, mutant NPM1, t(6,9), or decrease in CD34 chimerism] | 6-12 additional cycles of azacitidine | June 2020 |
| MD Anderson Cancer Center, Houston, TX | NCT02684162 | 2 | 90 | 15-75 | Patients with AML, MDS, or CMML and posttransplantation relapse | Flow cytometry, cytogenetics, or molecular markers | SGI-110 + DLI | June 2022 |
| University Chicago, Chicago, IL, and various sites in United States | NCT02275533 | 2 | 80 | >18 | Patients in CR1 or CRi after induction or consolidation | Longitudinal PCR for WT1 expression | Randomized to nivolumab vs observation | June 2019 |
| University California San Francisco, San Francisco, CA | NCT02458235 | 2 | 67 | <30 | AML, ALL, MDS, or JMML patients undergoing allo-SCT; risk determined by GVHD, chimerism, and MRD status | Flow cytometry + gene expression profiling when feasible | Azacitidine + DLI in high-risk patients | December 2019 |
| Institute of Hematology and Blood Diseases Hospital, Tianhin, China | NCT03021395 | 1/2 | 300 | 14-55 | Primary AML in CR, postconsolidation | Postconsolidation, not specified | Decitabine for patients not undergoing transplantation | December 2022 |
| Sponsor/trial . | Identifier . | Phase . | Estimated N of participants . | Patient age, y . | Clinical notes . | MRD assessment . | MRD+ intervention . | Expected completion . |
|---|---|---|---|---|---|---|---|---|
| Cardiff University; UK MRC AML 18 | NCT02272478 | 3 | 1600 | >60 | Older patients with primary or secondary AML or high-risk MDS; DA or DA + GO induction | Postinduction, flow cytometry based | MRD+ patients randomized to DA, DA + cladaribine, or FLAG-Ida | October 2020 |
| Hospital La Fe, Spain; PETHEMA-LMA 10 | NCT01296178 | 3 | 200 | <65 | Primary or secondary, treatment-naïve, non-APL AML patients; cytarabine + Ida induction | Flow cytometry and molecular based | Risk-adapted, MRD-directed therapy, not specified | December 2018 |
| Various sites in Germany; RELAZA2 | NCT01462578 | 2 | 93 | >18 | AML or MDS patients with detectable molecular markers after chemotherapy or allo-SCT | Patient-specific molecular markers [eg, mutant NPM1, t(6,9), or decrease in CD34 chimerism] | 6-12 additional cycles of azacitidine | June 2020 |
| MD Anderson Cancer Center, Houston, TX | NCT02684162 | 2 | 90 | 15-75 | Patients with AML, MDS, or CMML and posttransplantation relapse | Flow cytometry, cytogenetics, or molecular markers | SGI-110 + DLI | June 2022 |
| University Chicago, Chicago, IL, and various sites in United States | NCT02275533 | 2 | 80 | >18 | Patients in CR1 or CRi after induction or consolidation | Longitudinal PCR for WT1 expression | Randomized to nivolumab vs observation | June 2019 |
| University California San Francisco, San Francisco, CA | NCT02458235 | 2 | 67 | <30 | AML, ALL, MDS, or JMML patients undergoing allo-SCT; risk determined by GVHD, chimerism, and MRD status | Flow cytometry + gene expression profiling when feasible | Azacitidine + DLI in high-risk patients | December 2019 |
| Institute of Hematology and Blood Diseases Hospital, Tianhin, China | NCT03021395 | 1/2 | 300 | 14-55 | Primary AML in CR, postconsolidation | Postconsolidation, not specified | Decitabine for patients not undergoing transplantation | December 2022 |
An overview of ongoing trials that depend on MRD assessment for guidance in subsequent patient management. Observational protocols, or those where MRD data are collected but not used in treatment decisions, are excluded. Trials focused solely on pediatric populations are also excluded.
ALL, acute lymphoblastic leukemia; allo-SCT, allogeneic stem-cell transplantation; APL, acute promyelocytic leukemia; CMML, chronic myelomonocytic leukemia; CR1, first CR; CRi, incomplete CR; DA, daunorubicin plus cytarabine; DLI, donor lymphocyte infusion; FLAG, fludarabine, cytarabine, and granulocyte colony-stimulating factor; GO, gemtuzumab ozogamicin; GVHD, grant-versus-host disease; Ida, idarubicin; JMML, juvenile myelomonocytic leukemia.