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

Phase 1

• Conditions: Acute lymphoblastic leukaemia; MedDRA version: 20.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-004877-42-ES
• Lead Sponsor: FUNDACIÓN PETHEMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-28
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

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 < 0.1%) (< 1×10–3) centralised assessment through flow cytometry) after induction therapy.
4. ECOG < 2.
5. Ability to understand the study and willingness to sign the written informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified