A study to treat adult patients who suffer from a low amount of remaining blood cancer cells after chemotherapy
- Conditions
- Patients with minimal residual disease (MRD) of positive B-precursor acute lymphoblastic leukemia (ALL)MedDRA version: 17.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-006520-19-DE
- Lead Sponsor
- Amgen Research (Munich) GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. B–precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
2. Patients must have a molecular marker for evaluation of minimal residual disease which is either:
- Bcr/abl at any detection level and/or t (4;11) translocation at any detection level messured by reverse transcription - polymerase chain reaction (RT-PCR)
- Individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level equal or greater than 10-4.
3. ECOG Performance Status equal or smaller than 1.
4. Age equal or older than 18 years
5. Ability to understand and willingness to sign a written informed consent
6. 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Current extra medullar involvement
2. History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebro-spinal fluid (CSF) by ALL, age-related findings such as arteriosclerosis or findings induced by radiation or chemotherapy)
3. Current infiltration of cerebro-spinal fluid by ALL
4. History of or current autoimmune disease
5. Autologous stem cell transplantation within 6 weeks prior to study entry
6. Any prior allogeneic stem cell transplantation
7. Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
8. Radiotherapy within 4 weeks prior to study treatment
9. Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
10. Any investigational product within 4 weeks prior to study entry
11. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
12. Presence of human anti-murine antibodies (HAMA)
13. Abnormal bone marrow function as defined below:
- WBC < 3 000/mL
- Platelets < 50 000/mL
14. Abnormal renal or hepatic function as defined below:
- AST (SGOT) and/or ALT (SGPT) and/or AP equal or greater than 2 x upper limit of normal (ULN)
- GGT > 5 x ULN
- Total bilirubin equal or greater than 1.5 x ULN
- Creatinine clearance < 50 mL/min determined by the Cockroft-Gould formula.
15. Indication for a hypercoagulative state as defined below:
- D-Dimer equal or greater than 2,5 x ULN
- Antithrombin activity < 70%
16. Presenc of malignancy other than ALL
17. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
18. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)
19. Pregnant or nursing women
20. 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 dur-ing 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 Main Objective: To assess the efficacy of blinatumomab as defined by the effect on minimal residual disease (MRD)<br><br>;Secondary Objective: - To assess the effect of blinatumomab on duration of complete hematological remission<br>- To assess the impact of blinatumomab on the level of MRD<br>- To assess the effect of blinatumomab on duration of MRD negativity<br>- To evaluate the safety and tolerability of blinatumomab <br>- To evaluate the pharmacodynamics of blinatumomab<br>- To evaluate the pharmacokinetics of blinatumomab;Primary end point(s): MRD response rate defined by the incidence of MRD negativity within four cycles of treatment with MT103. MRD negativity is defined as bcr/abl below detection limit and/or by individual rearrangements of immunoglobulin or TCR-genes below 10-4.;Timepoint(s) of evaluation of this end point: Incidence of MRD-negativity within 4 cycle´s of blinatumomab treatment
- Secondary Outcome Measures
Name Time Method