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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)

Phase 2
18 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

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Trial Information

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)

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

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.

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

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR + CRh* rate

Outcome Description:

rate of complete remission and complete remission with partial hematologic recovery within in the first two treatment cycles

Outcome Time Frame:

within 10 weeks

Safety Issue:


Principal Investigator

Nicola Gökbuget, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der Goethe Universität Frankfurt


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

June 2017

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • B-ALL
  • relapsed ALL
  • refractory ALL
  • adult ALL
  • Leukemia
  • Leukemia, Lymphoid
  • precursor cell lymphoblastic leukemia-lymphoma
  • Lymphatic diseases
  • Lymphoproliferative disorders
  • bispecific antibody
  • anti-CD19
  • Immunotherapeutic treatment
  • immunoproliferative disorders
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



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University of California Los AngelesLos Angeles, California  90095-6951
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University of Texas MD Anderson Cancer CenterHouston, Texas  77030
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