Early phase trials for the treatment of relapsed pediatric ALL
| Completed trials . | ||||
|---|---|---|---|---|
| ClinicalTrials.gov identifier . | Phase . | Investigational agent class . | Treatment regimen . | Population . |
| NCT0152397781 | 1 | mTOR inhibitor | Everolimus plus 4-drug reinduction | Relapsed B- and T-ALL |
| NCT008730939 | 2 | Proteasome inhibitor | Bortezomib plus 4-drug reinduction | Relapsed B- and T-ALL |
| NCT0098179973 | 1 | Nucleoside analog | Nelarabine plus cyclophosphamide and etoposide | Relapsed T-ALL |
| NCT0122278056 | 1 | Vinca alkaloid | Liposomal vincristine | Relapsed B- and T-ALL |
| NCT0147178224 | 1/2 | Bispecific antibody | Blinatumomab | Relapsed CD19+ B-ALL |
| NCT0159369690 | 1 | CAR T-cells | CD19-redirected CAR-T cells | Relapsed CD19+ B-ALL |
| NCT0162649542,43 | 1/2 | CAR T-cells | CD19-redirected CAR-T cells (CTL019) | Relapsed CD19+ B-ALL |
| NCT0202845540 | 1/2 | CAR T-cells | CD19-redirected CAR-T cells | Relapsed CD19+ B-ALL |
| NCT0231561239 | 1 | CAR T-cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| Completed trials . | ||||
|---|---|---|---|---|
| ClinicalTrials.gov identifier . | Phase . | Investigational agent class . | Treatment regimen . | Population . |
| NCT0152397781 | 1 | mTOR inhibitor | Everolimus plus 4-drug reinduction | Relapsed B- and T-ALL |
| NCT008730939 | 2 | Proteasome inhibitor | Bortezomib plus 4-drug reinduction | Relapsed B- and T-ALL |
| NCT0098179973 | 1 | Nucleoside analog | Nelarabine plus cyclophosphamide and etoposide | Relapsed T-ALL |
| NCT0122278056 | 1 | Vinca alkaloid | Liposomal vincristine | Relapsed B- and T-ALL |
| NCT0147178224 | 1/2 | Bispecific antibody | Blinatumomab | Relapsed CD19+ B-ALL |
| NCT0159369690 | 1 | CAR T-cells | CD19-redirected CAR-T cells | Relapsed CD19+ B-ALL |
| NCT0162649542,43 | 1/2 | CAR T-cells | CD19-redirected CAR-T cells (CTL019) | Relapsed CD19+ B-ALL |
| NCT0202845540 | 1/2 | CAR T-cells | CD19-redirected CAR-T cells | Relapsed CD19+ B-ALL |
| NCT0231561239 | 1 | CAR T-cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| Ongoing trials* . | ||||
|---|---|---|---|---|
| ClinicalTrials.gov identifier . | Phase . | Drug class . | Treatment regimen . | Population . |
| NCT02303821 | 1B | Proteasome inhibitor | Carfilzomib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03888534 | 1 | Proteasome inhibitor | Ixazomib plus reinduction therapy | Relapsed B and T-ALL |
| NCT03817320 | 1 | Proteasome inhibitor | Ixazomib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03792256 | 1 | CDK4/6 inhibitor | Palbociclib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03515200 | 1 | CDK4/6 inhibitor | Palbociclib plus reinduction therapy | Relapsed B and T-ALL |
| NCT03740334 | 1 | CDK4/6 inhibitor | Ribociclib plus everolimus | Relapsed B and T-ALL |
| NCT0323685787 | 1 | BCL2 inhibitor | Venetoclax | Relapsed B and T-ALL |
| NCT0318112688 | 1 | BCL2 inhibitor | Venetoclax/navitoclax | Relapsed B and T-ALL |
| NCT03328104 | 1 | mTOR inhibitor | Everolimus plus NECTAR | Relapsed T-ALL |
| NCT01614197 | 1 | mTOR inhibitor | Temsirolimus plus reinduction therapy | Relapsed T-ALL |
| NCT04029688 | 1/2 | MDM2 inhibitor | Idasanutlin plus venetoclax | Relapsed B-ALL |
| NCT02879643 | 1 | Vinca alkaloid | Liposomal vincristine plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03384654 | 2 | Anti-CD38 monoclonal antibody | Daratumumab | Relapsed T-ALL |
| NCT0298162854 | 2 | Anti-CD22 conjugated monoclonal antibody | Inotuzumab ozogamicin | Relapsed CD22+ B-ALL |
| ITCC-05991 | 1 | Anti-CD22 conjugated monoclonal antibody | Inotuzumab ozogamicin single agent and plus 3-drug induction† | Relapsed CD22+ B-ALL |
| EudraCT 2016-000227-71 | ||||
| NCT024358497 | 2 | CAR-T cells | CD19-redirected CAR-T cells (CTL019) | Relapsed CD19+ B-ALL |
| NCT03792633 | 1/2 | CAR-T cells | Humanized CD19-redirected CAR-T cells (CTL119) | Relapsed CD19+ B-ALL |
| NCT02650414 | 1 | CAR T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT02315612 | 1 | CAR-T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT04088864 | 1B | CAR-T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT03448393 | 1 | CAR-T cells | CD19/CD22-redirected CAR-T cells | Relapsed CD19+/CD22+ B-ALL |
| NCT03241940 | 1 | CAR-T cells | CD19/CD22-redirected CAR-T cells | Relapsed CD19+/CD22+ B-ALL |
| Ongoing trials* . | ||||
|---|---|---|---|---|
| ClinicalTrials.gov identifier . | Phase . | Drug class . | Treatment regimen . | Population . |
| NCT02303821 | 1B | Proteasome inhibitor | Carfilzomib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03888534 | 1 | Proteasome inhibitor | Ixazomib plus reinduction therapy | Relapsed B and T-ALL |
| NCT03817320 | 1 | Proteasome inhibitor | Ixazomib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03792256 | 1 | CDK4/6 inhibitor | Palbociclib plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03515200 | 1 | CDK4/6 inhibitor | Palbociclib plus reinduction therapy | Relapsed B and T-ALL |
| NCT03740334 | 1 | CDK4/6 inhibitor | Ribociclib plus everolimus | Relapsed B and T-ALL |
| NCT0323685787 | 1 | BCL2 inhibitor | Venetoclax | Relapsed B and T-ALL |
| NCT0318112688 | 1 | BCL2 inhibitor | Venetoclax/navitoclax | Relapsed B and T-ALL |
| NCT03328104 | 1 | mTOR inhibitor | Everolimus plus NECTAR | Relapsed T-ALL |
| NCT01614197 | 1 | mTOR inhibitor | Temsirolimus plus reinduction therapy | Relapsed T-ALL |
| NCT04029688 | 1/2 | MDM2 inhibitor | Idasanutlin plus venetoclax | Relapsed B-ALL |
| NCT02879643 | 1 | Vinca alkaloid | Liposomal vincristine plus 4-drug reinduction | Relapsed B and T-ALL |
| NCT03384654 | 2 | Anti-CD38 monoclonal antibody | Daratumumab | Relapsed T-ALL |
| NCT0298162854 | 2 | Anti-CD22 conjugated monoclonal antibody | Inotuzumab ozogamicin | Relapsed CD22+ B-ALL |
| ITCC-05991 | 1 | Anti-CD22 conjugated monoclonal antibody | Inotuzumab ozogamicin single agent and plus 3-drug induction† | Relapsed CD22+ B-ALL |
| EudraCT 2016-000227-71 | ||||
| NCT024358497 | 2 | CAR-T cells | CD19-redirected CAR-T cells (CTL019) | Relapsed CD19+ B-ALL |
| NCT03792633 | 1/2 | CAR-T cells | Humanized CD19-redirected CAR-T cells (CTL119) | Relapsed CD19+ B-ALL |
| NCT02650414 | 1 | CAR T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT02315612 | 1 | CAR-T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT04088864 | 1B | CAR-T cells | CD22-redirected CAR-T cells | Relapsed CD22+ B-ALL |
| NCT03448393 | 1 | CAR-T cells | CD19/CD22-redirected CAR-T cells | Relapsed CD19+/CD22+ B-ALL |
| NCT03241940 | 1 | CAR-T cells | CD19/CD22-redirected CAR-T cells | Relapsed CD19+/CD22+ B-ALL |
This list includes selected molecularly and immunologically targeted therapies and does not include the exhaustive list of ongoing CD19-, CD22-, and CD19/22-directed CAR-T cell trials. See also Aldoss and Forman.41
Innovative Therapies for Children with Cancer in Europe (ITCC) Consortium: 3-drug induction with vincristine, dexamethasone, and pegaspargase.