Clinical phase II study to evaluate the efficacy and safety of the bispecific antibody blinatumomab (MT103) in adult patients with acute lymphoblastic leukemia (ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy
- Conditions
- Adult patients with relapsed / refractory B-precursor ALL.MedDRA version: 14.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002257-61-ES
- Lead Sponsor
- Micromet AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 61
1. Patients with Ph-negative B-precursor ALL, with any of the following:
- relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
- relapsed or refractory after first salvage therapy or
- relapsed or refractory within 12 months of allogeneic HSCT or
- if age 60 years or older: relapsed or refractory disease in first or later salvage independent of first remission duration
2. 10% or more blasts in bone marrow
3. In case of clinical signs of additional extramedullary disease: measurable disease (at least one lesion major or equal to 1.5 cm)
4. Eastern Cooperative Oncology Group (ECOG) performance status minor or equal to 2
5. Age major or equal to 18 years
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 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Patients with Ph-positive ALL
2. History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson disease, cerebellar disease, organic brain syndrome, psychosis
3. Active ALL in the CNS or testes
4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
5. Autologous HSCT within six weeks prior to start of blinatumomab treatment
6. Allogeneic HSCT within three months prior to start of blinatumomab treatment
7. Any active acute Graft-versus-Host Disease (GvHD), or active chronic GvHD Grade 2 to 4
8. Immunosuppressive therapy against GvHD within two weeks prior to start of blinatumomab treatment
9. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment (intrathecal prophylaxis and pre-phase with dexamethasone are allowed until start of blinatumomab treatment)
10. Radiotherapy within four weeks prior to start of blinatumomab treatment
11. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
12. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
13. Treatment with any other investigational medicinal product (IMP) after signature of informed consent
14. Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
15. Abnormal laboratory values as defined below:
a. AST (SGOT) and/or ALT (SGPT) and/or AP major or equal to 5 x upper limit of normal (ULN)
b. Total bilirubin major or equal to 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
c. Creatinine major or equal to 1.5 ULN or Creatinine clearance < 50 ml/min (calculated)
d. Hemoglobin (Hb) minor or equal to 9 g/dl (transfusion allowed)
16. Active malignancy requiring treatment other than ALL within two 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
17. Active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
18. 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 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
21. Previous treatment with blinatumomab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate efficacy of blinatumomab in patients with relapsed/refractory B-precursor ALL.;Secondary Objective: - To evaluate safety of blinatumomab in patients with relapsed/refractory B-precursor ALL <br>- To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of blinatumomab;Primary end point(s): CR (Complete response/remission) + CRh* (Complete response/remission with partial recovery of peripheral blood counts) rate within two cycles of treatment with blinatumomab.;Timepoint(s) of evaluation of this end point: At screening and at the end of each treatment cycle a bone marrow aspiration/biopsy will be performed to evaluate the efficacy of blinatumomab. <br>Following the last treatment cycle, there will be efficacy follow-up visits at three, six, nine, 12, 18 and 24 months after treatment start for patients who did not undergo allogeneic HSCT
- Secondary Outcome Measures
Name Time Method