A study to treat adult patients with a medicine who suffer from a low amount of remaining blood cancer cells after chemotherapy.
- Conditions
- minimal residual disease (MRD) of B-precursor ALLMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000012958Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-018314-75-BE
- Lead Sponsor
- Amgen Research (Munich) GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 116
1. Patients with B–precursor ALL in complete hematological remission defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks (e.g., GMALL induction I-II/consolidation I, induction/intensification/ consolidation or three blocks of Hyper CVAD)
2. Presence of minimal residual disease at a level of =10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy
3. For evaluation of minimal residual disease, patients must have at least one molecular marker based on individual rearrangements of immunoglobulin or TCR-genes or a flow cytometric marker profile, evaluated by a national or local reference lab approved by the Sponsor
4. Bone marrow or peripheral blood specimen from primary ALL diagnosis /diagnosis of ALL relapse (a sufficient amount of DNA or a respective amount of cell material) for clone-specific MRD assessment must be received by central MRD lab and lab must confirm that the sample is available
5. Bone marrow function as defined in the protocol
-ANC (Neutrophile) = 1 000/µL
-Thrombozyten = 50,000/µL (transfusion permitted)
-HB Level = 9g/dl (transfusion permitted)
6. Renal and hepatic function as defined in the protocol
-AST (GOT), ALT (GPT), und AP < 2 x upper limit of normal (ULN)
-Total bilirubin < 1.5 x ULN
-Creatinin-Clearance = 50 mL/min (e.g. calculated according Cockroft & Gault)
7. Negative HIV test, negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test
8. Negative pregnancy test in women of childbearing potential
9. ECOG Performance Status 0 or 1
10. Age =18 years
11. Ability to understand and willingness to sign a written informed consent
12. 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. Presence of circulating blasts or current extramedullary involvement by ALL
2. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
3. Current infiltration of cerebrospinal fluid by ALL
4. History of or active relevant autoimmune disease
5. Prior allogeneic HSCT
6. Eligibility for treatment with TKIs (i.e., Philadelphia chromosome-positive (Ph) patients with no documented treatment failure of or intolerance/contraindication to at least 2 TKIs)
7. Systemic cancer chemotherapy within 2 weeks prior to study treatment, (except for intrathecal prophylaxis)
8. Radiotherapy within 4 weeks prior to study treatment
9. Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to study treatment
10. Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
11. Treatment with any investigational product within four weeks prior to study treatment
12. Previous treatment with blinatumomab
13. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
14. Active malignancy other than ALL with the exception of basal cell or
squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
15. Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
16. Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method