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|ClinicalTrials.gov Identifier: NCT03523429|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : April 7, 2020
The PETHEMA Spanish group treats patients with high-risk Philadelphia chromosome-negative ALL, aged 18 to 55 years, based on the MRD clearance as assessed by flow cytometry at a centralised evaluation centre. Patients with MRD < 0.1% (< 1×10-3) after induction and < 0.01% (< 1×10-4) after early consolidation are assigned to receive chemotherapy (late consolidation and maintenance).
Early consolidation chemotherapy consists of three cycles including high doses of MTX, ARA-C and ASP, together with vincristine and dexamethasone. The same therapy is repeated in the late consolidation period if MRD after early consolidation is < 0.01% (< 1×10-4). Maintenance therapy is then administered for up to 2 years from the CR date. These patients do not receive allo-HSCT if they maintain adequate MRD clearance.
Despite having adequate MRD clearance, a proportion of patients (around 25%) experience relapse, which makes other approaches necessary to try to decrease the relapse rate. Intensifying currently existing chemotherapy regimens is not likely to increase the cure rate and would likely significantly increase toxicity. The use of targeted immunotherapeutic agents such as blinatumomab, which has demonstrated efficacy and safety in patients with R/R ALL and in patients with ALL and MRD+, seems to be a promising option [30-33].
Therefore, it would be interesting to assess the potential efficacy of using blinatumomab in CR patients to reduce the MRD more frequently and more intensely during the early and late consolidation period. Our hypothesis is that blinatumomab will further reduce the level of MRD and this could lead to a decrease in the relapse rate in these patients.
This trial will replace the third early consolidation cycle with a cycle of blinatumomab, and the same will be done in the late consolidation period. We hope that this strategy will increase the extent of the MRD response and prevent relapses.
Moreover, and as a secondary objective, we will investigate the safety of blinatumomab administration after the administration of high-dose chemotherapy including MTX, ARA-C and ASP
|Condition or disease||Intervention/treatment||Phase|
|Philadelphia Chromosome-negative or BCR-ABL-negative, CD19-positive ALL||Drug: blinatumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy|
|Actual Study Start Date :||June 30, 2018|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
blinatumomab administered during the early consolidation phase in patients ≤ 55 years with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy.
Blinatumomab is a bispecific monoclonal antibody designed to bind specifically to CD19, expressed on the surface of B-cells, and to CD3, expressed on the surface of T-cells. It activates endogenous T-cells by connecting the CD3 on the T-cell receptor complex (TCR) with the CD19 on the B-cells. The anti-tumour activity of blinatumomab does not depend on whether the T-cells carry a specific TCR or peptide antigens present in cancer cells, but it is polyclonal and independent of HLA on the target cells
- To assess the reduction rate of the Minimal residual disease determined by Multiparametric flow cytometry [ Time Frame: 1 year ]To assess the reduction rate of the MRD determined by MFC, after early consolidation following the inclusion of blinatumomab administered during the early consolidation phase in patients ≤ 55 years of age with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with MRD < 0.1% (< 1×10-3) after induction therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523429
|Hospital Germans Trias i Pujol and all Hospital Pethema||Recruiting|
|Badalona, Barcelona, Spain|
|Contact: Jose Mª Ribera, Dr 93 465 12 00 firstname.lastname@example.org|
|Hospital ICO Hospitalet||Recruiting|
|Contact: Santiago Mercadal, Dr 932 607 733 email@example.com|
|Hospital Vall d'Hebron||Recruiting|
|Contact: Barba Pere, Dr + 34 934 89 30 00 firstname.lastname@example.org|
|Hospital Universitario 12 de Octubre||Recruiting|
|Contact: Pilar Martínez Sánchez, Dr 913908047 email@example.com|
|. Hospital Clínico Universitario Virgen de la Victoria||Recruiting|
|Contact: Moreno Mª José, Dr 951 032 596 firstname.lastname@example.org|
|Hospital Central de Asturias||Recruiting|
|Contact: Teresa Bernal del Castillo, Dr + 34 985 108 000 email@example.com|
|Hospital Clinico Universitario de Salamanca||Recruiting|
|Contact: Jesús Maria Hernández Rivas, Dr 923 29 11 00 firstname.lastname@example.org|
|H. Virgen Del Rocio||Recruiting|
|Contact: José González Campos, Dr 955012218 email@example.com|
|Hospital Universitario y Politécnico la Fe||Recruiting|
|Contact: Pau Montesinos, Dr +34 963 86 27 00 firstname.lastname@example.org|