Spots Global Cancer Trial Database for Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
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Trial Identification
Brief Title: Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Official Title: A Multicentre, Randomized Trial in Adults With de Novo Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia to Assess the Efficacy of Ponatinib Versus Imatinib in Combination With Low-intensity Chemotherapy, to Compare End of Therapy With Indication for SCT Versus TKI, Blinatumomab and Chemotherapy in Optimal Responders and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE)
Study ID: NCT06061094
Study Description
Brief Summary: The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation. The EVOLVE trial aims to answer three questions challenging the current SoC: Use of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I). In MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II). In MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Medicine, Hematology and Oncology, Goethe University Hospital Frankfurt, Frankfurt, , Germany
Contact Details
Name: Nicola Goekbuget, MD
Affiliation: Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Fabian Lang, MD
Affiliation: Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Heike Pfeifer, MD
Affiliation: Department of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany
Role: PRINCIPAL_INVESTIGATOR
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