Effect of Blinatumomab in adult patients up to 55 years with acute lymphoblastic leukemia

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004877-42-ES

Enrollment

Registered

2018-02-28

Start date

2018-04-25

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukaemia MedDRA version: 20.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 100000004864

Interventions

Trade Name: BLINCYTO Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: BLINATUMOMAB Current Sponsor code: BLINATUMOMAB Other descriptive name: BLINATUMOMAB Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women between 18 to 55 years of age, both inclusive. 2. Patients with Philadelphia chromosome-negative or BCR-ABL-negative, CD19-positive ALL, with high-risk characteristics. The definition of high-risk ALL implies the presence of one or more of the following factors: - Aged 30–55 years. - Leukocytes > 30×109/l in B-precursor ALL. - Any of the following cytogenetic or molecular abnormalities: o 11q23 abnormalities, or proven MLL rearrangement. o Complex karyotype (more than 5 chromosome abnormalities). - Pro-B ALL, regardless of the number of leukocytes. 3. Previous treatment according to routine clinical practice in Spanish centres, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), in complete remission (MRD =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. ALL with Philadelphia chromosome (Ph +). 2. Burkitt's leukemia (mature B phenotype) according to the WHO classification. 3. T cell ALL 4. ALL of precursors B with high risk characteristics with ER =0.1% (=1x10-3) after receiving induction chemotherapy. 5. Previous history or presence of clinically significant disease of the central nervous system (CNS): epilepsy, seizures, paresis, aphasia, stroke, brain injuries severe, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis. 6. Presence or history of autoimmune disease with potential CNS involvement. 7. Radiotherapy in the 2 weeks prior to the start of treatment with blinatumomab. 8. Immunotherapy (eg, rituximab) in the 4 weeks prior to the start of treatment with blinatumomab. 9. Any product under investigation for leukemia in the 4 weeks prior to the start of the treatment with blinatumomab. 10. Treatment with any investigational medication after signing the consent informed. 11. Candidate candidate for allogeneic transplantation of hematopoietic progenitors (TPH) in the moment of inclusion. 12. Known hypersensitivity to immunoglobulins or to any component of the product in investigation. 13. Abnormal laboratory values: to. AST (SGOT) and / or ALT (SGPT) and / or alkaline phosphatase =5 ? LSN. b. Total bilirubin =1.5 ? ULN (except if it is related to Gilbert's disease or Meulengracht). c. Creatinine =1.5 ? LSN. d. Creatinine clearance calculated <50 ml / min. and. Hemoglobin =9 g / dl (transfusion allowed). 14. History of malignant disease different from ALL in the 5 years prior to the start of treatment with blinatumomab, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 15. Non-controlled active infection, or any other concurrent medical condition or disease that it is considered that it interferes with the performance of the study according to the researcher's criteria. 16. HIV infection or chronic infection with hepatitis B virus (HBs Ag positive) or virus of the Hepatitis C (anti-HCV positive). 17. Pregnant or lactating women. 18. Women of childbearing age who are not willing to use effective contraception during Participation in the study and until at least 3 months later. Men who are not willing to take measures to avoid pregnancy of the couple during participation in the study and less until 3 months later. 19. Previous treatment with blinatumomab. 20. Patients who do not want or can not comply with the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the MRD reduction rate, determined by flow cytometry, after early consolidation following the inclusion of 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;Secondary Objective: • To assess the MRD reduction rate, determined by flow cytometry, after late consolidation phase. • To assess 5-year disease-free survival. • To assess 5-year overall survival. • To assess the extent of MRD reduction. • To compare these efficacy results with those of similar patients treated with standard consolidation therapy without blinatumomab (Protocol ALL-AR-11), measured as a comparison of the percentages of patients reaching a MRD level of < 0.01% (< 1×10–4) at the end of the consolidation in this trial and in the ALL-AR-11 study. • To assess the MRD kinetics during maintenance therapy and during the follow-up period once the ALL treatment has been completed. • To assess the safety of treatment with blinatumomab administered during early and late consolidation;Primary end point(s): The primary endpoint of the study will be the percentage of patients achieving MRD < 0.01% (< 1×10–4).;Timepoint(s) of evaluation of this end point: Percentage of patients achieving MRD < 0.01% (< 1×10–4) at the end of early consolidation.	—

Measure

Time frame

Main Objective: To assess the MRD reduction rate, determined by flow cytometry, after early consolidation following the inclusion of 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;Secondary Objective: • To assess the MRD reduction rate, determined by flow cytometry, after late consolidation phase. • To assess 5-year disease-free survival. • To assess 5-year overall survival. • To assess the extent of MRD reduction. • To compare these efficacy results with those of similar patients treated with standard consolidation therapy without blinatumomab (Protocol ALL-AR-11), measured as a comparison of the percentages of patients reaching a MRD level of < 0.01% (< 1×10–4) at the end of the consolidation in this trial and in the ALL-AR-11 study. • To assess the MRD kinetics during maintenance therapy and during the follow-up period once the ALL treatment has been completed. • To assess the safety of treatment with blinatumomab administered during early and late consolidation;Primary end point(s): The primary endpoint of the study will be the percentage of patients achieving MRD < 0.01% (< 1×10–4).;Timepoint(s) of evaluation of this end point: Percentage of patients achieving MRD < 0.01% (< 1×10–4) at the end of early consolidation.

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Secondary

Measure	Time frame
Secondary end point(s): • Percentage of patients achieving MRD < 0.01% (< 1×10–4). • Disease-free survival. • Overall survival. • Levels of minimal residual disease. • Toxicity profile of the treatment with blinatumomab.;Timepoint(s) of evaluation of this end point: • MRD < 0.01% (< 1×10–4) at the end of late consolidation. • 5-year disease-free survival. • 5-year overall survival. • Levels of minimal residual disease: after treatment with blinatumomab , during the maintenance period (every 3 months) and during follow-up after discontinuing treatment (every 3 months for the first 2 years after completing CT, every 6 months during year 3 and at the end of the follow-up) • Toxicity profile of the treatment with blinatumomab administered after two consolidation cycles.	—

Measure

Time frame

Secondary end point(s): • Percentage of patients achieving MRD < 0.01% (< 1×10–4). • Disease-free survival. • Overall survival. • Levels of minimal residual disease. • Toxicity profile of the treatment with blinatumomab.;Timepoint(s) of evaluation of this end point: • MRD < 0.01% (< 1×10–4) at the end of late consolidation. • 5-year disease-free survival. • 5-year overall survival. • Levels of minimal residual disease: after treatment with blinatumomab , during the maintenance period (every 3 months) and during follow-up after discontinuing treatment (every 3 months for the first 2 years after completing CT, every 6 months during year 3 and at the end of the follow-up) • Toxicity profile of the treatment with blinatumomab administered after two consolidation cycles.

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Countries

Spain

Contacts

Public ContactJuan José Lahuerta Palacios

FUNDACIÓN PETHEMA

jjlahuerta@telefonica.net0034913303011

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026