Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003848

Trial Description

start of 1:1-Block title

Title

An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to confirm whether the bispecific T cell engager antibody
blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or
refractory Acute Lymphoblastic Leukemia (ALL).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease
with dismal prog-nosis. Several studies have reported long term survival to be below 10%.
Major prognostic factors are duration of first complete remission (CR1) and age. With
current salvage chemotherapy, complete remission (CR) rate is low (20 to 30%) in patients in
first salvage with short duration (< one year) of first remission, patients relapsed after
first salvage, or patients aged 60 years and older. Duration of CR is usually very short
(median disease free survival [DFS]: 2.0-7.5 months). Allogeneic hematopoietic stem cell
transplantation (HSCT) may provide a curative treatment option for patients in CR with a
satisfactory donor and appropriate clinical status including age, organ function, and
remission status. Allogeneic HSCT is not an option in most elderly patients with relapsed
ALL. Additional therapeutic approaches are urgently needed.

Blinatumomab (also termed MT 103) is a bispecific single-chain antibody derivative against
CD (cluster of differentiation)19 and CD3, designed to link B cells and T cells resulting in
T cell activation and a cytotoxic T cell response against CD19 expressing cells. In vitro
data indicate CD19+ lymphoma and leukemia cell lines to be extremely sensitive to
blinatumomab-mediated cytotoxicity.Blinatumomab has the potential to provide meaningful
therapeutic benefits to patients compared with existing treatments for this patient
population.

The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab
(MT103) is effective and safe in the treatment of patients with relapsed or refractory ALL.
Patients will receive up to five 4-week cycles of intravenous blinatumomab treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003848
  •   2012/04/30
  •   2011/10/28
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-002257-61 
  •   NCT01466179  (ClinicalTrials.gov)
  •   MT103-211  (Micromet GmbH)
  •   2011-002257-61 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Acute Lymphoblastic Leukemia
  •   C91.0 -  Acute lymphoblastic leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Blinatumomab
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- CR + CRh* rate; time frame: within 10 weeks; rate of complete remission and complete remission with partial hematologic recovery within in the first two treatment cycles

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Proportion of patients eligible for allogeneic hematopoietic stem cell transplantation (HSCT) who undergo the procedure after treatment with blinatumomab; time frame: within 17 months
- CR rate; time frame: within 10 weeks
- CRh* rate; time frame: within 10 weeks
- Partial remission (PR) rate; time frame: within 10 weeks
- Relapse-free survival; time frame: up to 4 years
- Overall survival; time frame: up to 4 years
- Number of AEs per patient; time frame: up to 8 months
- 100-day mortality after allogeneic HSCT; time frame: within 4 years
- Steady state concentration of blinatumomab (pharmacokinetics); time frame: within 10 weeks
- Serum cytokine concentrations; time frame: up to 2 years
- Rate of MRD response; time frame: within 10 weeks
- Rate of MRD complete response; time frame: within 10 weeks
- Time to hematological relapse; time frame: up to 4 years
- Event-free survival; time frame: up to 4 years
- Concentration of peripheral blood lymphocyte subsets; time frame: up to 2 years

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   France
  •   Germany
  •   Italy
  •   Spain
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2011/11/30
  •   180
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- 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

- 10% or more blasts in bone marrow

- In case of clinical signs of additional extramedullary disease: measurable disease

- ECOG performance status ≤ 2

- Age ≥ 18 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Patients with Ph-positive ALL

- Patients with Burkitt's Leukemia according to WHO classification

- History or presence of clinically relevant CNS pathology

- Active ALL in the CNS or testes

- Current autoimmune disease or history of autoimmune disease with potential CNS
involvement

- Autologous HSCT within six weeks prior to start of blinatumomab treatment

- Allogeneic HSCT within three months prior to start of blinatumomab treatment

- Any active acute GvHD, or active chronic GvHD Grade 2 - 4

- Any systemic therapy against GvHD within two weeks prior to start of blinatumomab
treatment

- Cancer chemotherapy within two weeks prior to start of blinatumomab treatment

- Radiotherapy within two weeks prior to start of blinatumomab treatment

- Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab
treat-ment

- Any investigational anti-leukemic product within four weeks prior to start of
blinatumomab treatment

- Treatment with any other IMP after signature of informed consent

- Eligibility for allogeneic HSCT at the time of enrollment

- Known hypersensitivity to immunoglobulins or to any other component of the IMP
formulation

- Abnormal laboratory values indicative of inadequate renal or liver function

- History of malignancy requiring treatment 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

- Any concurrent disease or medical condition that is deemed to interfere with the
conduct of the study

- Infection with HIV or chronic infection with hepatitis B virus or hepatitis C virus

- Pregnant or nursing women

- Women of childbearing potential not willing to use an effective form of
contraception. Male patients not willing to ensure not to beget a child

- Previous treatment with blinatumomab

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Amgen Research (Munich) GmbH
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinikum der Goethe Universität Frankfurt
    • Nicola Gökbuget, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Tap Maniar, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   11
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.