Main info

Identificatie:

HO146 ALL

Sponsor:

HOVON

Working group party:

Leukemia

Age:

18-70

Stadium:

1st lijn

Echelon:

Level B

Included patients:

71

(of 71)

Active sites:

15

(of 18)

Title:

Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults.

Timeline

News

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Site Evaluation Visit

Objectives:

Primary objective:

• To assess the proportion of patients that achieve MRD negative response (by PCR) after the first consolidation phase including blinatumomab

Secondary objectives:
To assess the MRD level following induction chemotherapy

• To assess the MRD level after second blinatumomab consolidation
• To assess the hematological response after induction, blinatumomab consolidation I and blinatumomab consolidation II
• To evaluate event-free survival (EFS)
• To evaluate relapse-free survival (RFS)
• To evaluate overall survival (OS)
• To evaluate safety and toxicity of blinatumomab
• To assess clinical outcome of patients receiving maintenance or allogeneic SCT
• To assess kinetics of T-cells and B-cells and their various subsets during treatment and assess their predictive value as regard to molecular response
• To compare the results of molecular and flowcytometric MRD measurements at the same timepoints.

Eligibility

Inclusion Criteria:

• Primary CD19 positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL);
• Patients aged 18 to 70 years inclusive;
• WHO performance status 0-2;
• Negative pregnancy test at inclusion, if applicable;
• Written informed consent;
• Patient is capable of giving informed consent.

Exclusion Criteria:

• Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease;
• CML in blast crisis;
• Acute undifferentiated leukemia;

*Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed:

o Basal or squamous cell carcinoma of the skin
o Carcinoma in situ of the cervix
o Carcinoma in situ of the breast
o Incidental histologic finding of prostate carcinoma

• Patient known to be HIV-positive;
• Pregnant or breast-feeding female patients;
• Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 years for at least one year);
• Current participation in another clinical trial;
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals