A clinical trial to treat adult patients with a medicine who suffer from acute relapse of their blood cancer after chemotherapy

Phase 1

• Conditions: Patients with Relapsed/Refractory B-Precursor acute lymphoblastic leukemia (ALL); MedDRA version: 19.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-015989-62-DE
• Lead Sponsor: Amgen Research (Munich) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
a. Relapse is defined as reappearance of disease after CR having at least lasted for 28 days
b. Refractory disease is defined as not having achieved CR after induction and/or consolidation I
2. More than 5% blasts in bone marrow
3. ECOG performance status = 2
4. Age = 18 years
5. Life expectancy of = 12 weeks
6. Ability to understand and willingness to sign a written informed consent
7. Signed and dated written informed consent is available

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis
2. Infiltration of cerebrospinal fluid (CSF) and/or testis by ALL
3. History of autoimmune disease with potential CNS involvement or current autoimmune disease
4. Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to start of blinatumomab treatment
5. Allogeneic HSCT within three months prior to start of blinatumomab treatment
6. Eligibility for allogeneic HSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
7. Active Graft-versus-Host Disease (GvHD)
8. Immunosuppressive therapy against GvHD within one week prior to start of blinatumomab treatment
9. Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
10. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment and TKIs within 72 hours prior to start of blinatumomab treatment (intrathecal prophylaxis and/or steroids (=24 mg/d) are allowed until start of blinatumomab treatment.)
11. Radiotherapy within four weeks prior to start of blinatumomab treatment
12. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
13. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
14. Treatment with any other investigational product after signature of informed consent
15. Known hypersensitivity to immunoglobulin’s or to any other component of the study drug formulation
16. Presence of human anti-murine antibodies (HAMA)
17. Abnormal laboratory values as defined below:
a. AST (SGOT) and/or ALT (SGPT) and/or AP= 5 x upper limit of normal (ULN)
b. Total bilirubin = 1,5 x ULN
c. Creatinine clearance< 50 ml/min (calculated)
d. Hb = 9 g/dl (transfusion allowed)
e. Pathological findings of INR or PTT> 1,5 ULN
18. Symptoms or signs of disseminated intravascular coagulation (DIC)
19. History of malignancy other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix
20. Active infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
21. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)
22. Pregnant or nursing women
23. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Male patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
24. Previous treatment with blinatumomab

Study & Design

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