TABLE 6.
Currently recruiting BP‐CML clinical trials in adult patients using novel therapeutic approaches (excluding alloHSCT) on the www.clinicaltrials.gov website (accessed on April 26, 2022)
| Phase and trial title | Drug | Patient population | Primary end‐point | NCT number |
|---|---|---|---|---|
| Phase 1. ABL001 + dasatinib + prednisone for BCR‐ABL+ B‐ALL or CML |
Asciminib Dasatinib Prednisone |
Ph+ALL; lBP‐CML | MTD of asciminib | NCT03595917 |
| Phase 1. Study of HQP1351 in refractory CML and Ph+ALL |
Olverembatinib (HQP1351) Blinatumomab |
CP‐, AP‐ and BP‐CML, Ph+ALL | Cmax and AUC for HQP1351 | NCT04260022 |
| Phase 1. Fludarabine, cytarabine and pegcrisantaspase for the treatment of relapsed or refractory leukaemia |
Fludarabine Cytarabine Pegcrisantaspase |
AML, ALL, T‐PLL, biphenotypic AL, BP‐CML | Safety and tolerability of fludarabine, cytarabine and pegcrisantaspase | NCT04526785 |
| Phase 1. Hu8F4 in treating patients with advanced haematologic malignancies | Hu8F4 (anti‐PR1/HLA‐A2 monoclonal antibody) | HR‐MDS, CMML, AML, BP‐CML, HR‐MF | DLT and minimum safe and biologically‐effective dose | NCT02530034 |
| Phase 1/2. Venetoclax, ponatinib, and dexamethasone in participants with PH+ or BCR‐ABL positive relapsed or refractory ALL or chronic myelogenous leukemia |
Dexamethasone Ponatinib Venetoclax Rituximab |
Ph+ALL; lBP‐CML | MTD of venetoclax in combination with dexamethasone and ponatinib | NCT03576457 |
| Phase 2. PONAZA: A combination of ponatinib and 5‐azacitidine in chronic myelogenous leukaemia in AP or in myeloid blast crisis |
Ponatinib 5‐azacitidine |
AP‐CML and mBP‐CML | 2‐year OS | NCT03895671 |
| Phase 2. Cladribine, idarubicin, cytarabine and venetoclax in treating patients with AML, high‐risk myelodysplastic syndrome or BP‐CML |
Cladribine Idarubicin Cytarabine Venetoclax |
AML, HR‐MDS, BP‐CML | CR rate up to 12 months | NCT 02115295 |
| Phase 2. Decitabine, venetoclax and ponatinib for the treatment of Ph+ALL or mBP‐ or AP‐CML |
Decitabine Venetoclax Ponatinib |
Ph+AML, mBP‐CML, AP‐CML | CR/CRi rate | NCT04188405 |
| Phase 2. Low‐dose chemotherapy, ponatinib and blinatumomab in treating patients with Philadelphia chromosome‐positive and/or BCR‐ABL‐positive ALL |
Blinatumomab Cyclophosphamide Cytarabine Filgrastim Methotrexate PEGFilgrastim Ponatinib Rituximab Vincristine |
Newly diagnosed Ph+ALL and lBP‐CML | CMR in newly diagnosed Ph+ and/or BCR‐ABL+ recipients | NCT03147612 |
| Phase 2. Blinatumomab, cytarabine, methotrexate and ponatinib in treating patients with Philadelphia chromosome positive, or BCR‐ABL‐positive, or relapsed/refractory AL |
Blinatumomab Cytarabine Methotrexate Ponatinib |
Newly diagnosed and R/R Ph+ALL and lBP‐CML | CMR at 18 weeks | NCT03263572 |
Abbreviations: AL, acute leukaemia; A ALL, acute lymphoblastic leukaemia; alloHSCT, allogeneic haemopoietic stem cell transplantation; AML, acute myeloid leukaemia; AP, accelerated phase; AUC, area under curve; B‐ALL, B‐cell acute lymphoblastic leukaemia; BP, blast phase; Cmax, maximum plasma concentration; CMML, chronic myelomonocytic leukaemia; CMR, complete molecular response; CML, chronic myeloid leukaemia; CP, chronic phase; CR, complete response; CRi complete response with incomplete count recovery; DLT, dose‐limiting toxicity; HR‐MDS, high‐risk myelodysplastic syndrome; HR‐MF, high‐risk myelofibrosis; lBP, lymphoid blast phase; mBP, myeloid blast phase; MTD, maximum tolerated dose; OS, overall survival; Ph+ALL, Philadelphia chromosome‐positive ALL; T‐PLL, T‐cell prolymphocytic leukaemia.