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Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Blinatumomab

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with Philadelphia chromosome (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 hematopoietic stem cell transplantation (HSCT)
10% or more blasts in bone marrow
In case of clinical signs of additional extramedullary disease: measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Age ≥ 18 years

Exclusion Criteria:

Patients with Ph-positive ALL
Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
History or presence of clinically relevant central nervous system (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 graft versus-host disease (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 investigational medicinal product (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 human immunodeficiency virus (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

Sites / Locations

City of Hope
University of California Los Angeles
Winship Cancer Institute of Emory University
Rush University Medical Center
University of Chicago
Dana Farber Institute
Barbara Ann Karmanos Cancer Institute
Mayo Clinic
Washington University School of Medicine
Roswell Park Cancer Streets
University of Pennsylvania
University of Texas MD Anderson Cancer Center
CHU d'Angers
Hôpital de l'hôtel Dieu
Hôpital Saint Louis
CHU de Purpan
Charité - Campus Benjamin Franklin
Klinikum der Goethe Universität, Medizinische Klinik II
Universitätsklinikum Freiburg
Medizinische Hochschule Hannover
Universitätsklinikum Schleswig-Holstein
Universitätsklinikum Münster
Universitätsklinikum Tübingen
Universitätsklinikum Ulm
Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II
Ospedali Riuniti di Bergamo
Azienda Ospedaliera Antonio Cardarelli
Ospedali Riuniti "Villa Sofia-Cervello"
Università La Sapienza di Roma
Azienda Ospedaliero-Universitaria
Azienda Ospedaliera di Verona
ICO Hospital Germans Trias I Pujol
Hospital Clínic Servei d´Hematologia
Hospital 12 de Octubre
Hospital universitario de Salamanca
Hospital Universitario Virgen Del Rocio
University Hospitals Bristol NHS
Royal Free Hampstead NHS Trust
The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab

Arm Description

Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Hematological remissions were defined by the following criteria: Complete Remission (CR): bone marrow blasts ≤ 5% no evidence of disease full recovery of peripheral blood counts: platelets > 100,000/μL, and absolute neutrophil count (ANC) > 1,000/μL Complete Remission With Partial Hematological Recovery (CRh*): bone marrow blasts ≤ 5% no evidence of disease partial recovery of peripheral blood counts: platelets > 50,000/μL, and ANC > 500/μL.

Secondary Outcome Measures

Time to Hematological Relapse (Duration of Response)

Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death. Hematological relapse is defined as: proportion of blasts in bone marrow > 5% after documented CR/CRh* or blasts in peripheral blood after documented CR/CRh*. Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission

Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.

Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment

Complete Remission was defined by the following criteria: bone marrow blasts ≤ 5% no evidence of disease full recovery of peripheral blood counts: platelets > 100,000/μL, and absolute neutrophil count (ANC) > 1,000/μL

Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

Complete Remission With Partial Hematological Recovery was defined by the following criteria: bone marrow blasts ≤ 5% no evidence of disease partial recovery of peripheral blood counts: platelets > 50,000/μL, and ANC > 500/μL.

Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment

Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.

Relapse-free Survival

Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

Event-free Survival

Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later. Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.

Overall Survival

Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.

Number of Participants With Treatment-emergent Adverse Events

Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. An AE was considered "serious" if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition. Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events.

100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods.

Serum Blinatumomab Concentration at Steady State

The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.

Serum Cytokine Peak Levels

The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured. Serum IL-4 levels were below detection limit (< 20 pg/mL) at all time points in all participants studied.

Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment

Blast Free Hypoplastic or Aplastic Bone Marrow was defined as: bone marrow blasts ≤ 5% no evidence of disease insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL

Best Response During the Core Study

Complete Remission (CR): bone marrow blasts ≤ 5% no evidence of disease full recovery of peripheral blood counts: platelets > 100,000/μL, and absolute neutrophil count (ANC) > 1,000/μL Complete Remission With Partial Hematological Recovery (CRh*): bone marrow blasts ≤ 5% no evidence of disease partial recovery of peripheral blood counts: platelets > 50,000/μL, and ANC > 500/μL Blast Free Hypoplastic or Aplastic Bone Marrow: bone marrow blasts ≤ 5% no evidence of disease insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL Partial Remission: • bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline.

Full Information

NCT ID

NCT01466179

First Posted

October 28, 2011

Last Updated

July 18, 2017

Sponsor

Amgen Research (Munich) GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01466179

Brief Title

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen Research (Munich) GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed Description

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis. 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 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. This study consists of a screening period, a treatment period and a follow-up period. Participants receive one to five treatment cycles of blinatumomab at a target dose of 28 μg/day. In the first cycle, the initial dose is 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment. Participants who achieve remission within two cycles of treatment can receive up to three additional cycles of consolidation treatment or proceed to allogeneic HSCT. In the event of progression or relapse within the treatment period, treatment will be terminated. Participants with hematological relapse during the efficacy or safety follow-up period may receive up to three additional cycles of blinatumomab (retreatment) for a maximal total of eight cycles at the investigator´s discretion. Thirty days after end of the last treatment, participants have an end-of-core-study visit. Following this, there are efficacy follow-up visits at 3, 6, 9, 12, 18 and 24 months at the most after treatment start. Once efficacy follow-up is complete, information on survival collected at least every six months until death or at least until three years after treatment start, whichever occurs earlier (survival follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blinatumomab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Blinatumomab

Other Intervention Name(s)

AMG103, MT103, BLINCYTO™

Intervention Description

Continuous intravenous infusion over four weeks per treatment cycle

Primary Outcome Measure Information:

Title

Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

Description

Time Frame

Within the first 2 cycles of treatment, 12 weeks

Secondary Outcome Measure Information:

Title

Time to Hematological Relapse (Duration of Response)

Description

Time Frame

Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.

Title

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission

Description

Time Frame

Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.

Title

Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment

Description

Time Frame

Within the first 2 cycles of treatment, 12 weeks

Title

Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment

Description

Time Frame

Within the first 2 cycles of treatment, 12 weeks

Title

Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment

Description

Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.

Time Frame

Within the first 2 cycles of treatment, 12 weeks

Title

Relapse-free Survival

Description

Time Frame

Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.

Title

Event-free Survival

Description

Time Frame

Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.

Title

Overall Survival

Description

Time Frame

Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.

Title

Number of Participants With Treatment-emergent Adverse Events

Description

Time Frame

From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.

Title

100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

Description

Time Frame

From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.

Title

Serum Blinatumomab Concentration at Steady State

Description

Time Frame

Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.

Title

Serum Cytokine Peak Levels

Description

Time Frame

Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.

Title

Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment

Description

Time Frame

Within the first 2 cycles of treatment, 12 weeks

Title

Best Response During the Core Study

Description

Time Frame

From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with Philadelphia chromosome (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 hematopoietic stem cell transplantation (HSCT) 10% or more blasts in bone marrow In case of clinical signs of additional extramedullary disease: measurable disease Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Age ≥ 18 years Exclusion Criteria: Patients with Ph-positive ALL Patients with Burkitt's Leukemia according to World Health organization (WHO) classification History or presence of clinically relevant central nervous system (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 graft versus-host disease (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 investigational medicinal product (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 human immunodeficiency virus (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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicola Gökbuget, MD

Organizational Affiliation

Klinikum der Goethe Universität Frankfurt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Max Topp, MD

Organizational Affiliation

Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II, Würzburg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hagop Kantarjian, MD

Organizational Affiliation

MD Anderson Cancer Center, Houston, Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

University of California Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1678

Country

United States

Facility Name

Winship Cancer Institute of Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Dana Farber Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Barbara Ann Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Roswell Park Cancer Streets

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

CHU d'Angers

City

Angers

ZIP/Postal Code

49933

Country

France

Facility Name

Hôpital de l'hôtel Dieu

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Hôpital Saint Louis

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

CHU de Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Charité - Campus Benjamin Franklin

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Klinikum der Goethe Universität, Medizinische Klinik II

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitätsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein

City

Kiel

ZIP/Postal Code

24116

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitätsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Ospedali Riuniti di Bergamo

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

Azienda Ospedaliera Antonio Cardarelli

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Ospedali Riuniti "Villa Sofia-Cervello"

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Università La Sapienza di Roma

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria

City

Turin

ZIP/Postal Code

10126

Country

Italy

Facility Name

Azienda Ospedaliera di Verona

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

ICO Hospital Germans Trias I Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Clínic Servei d´Hematologia

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital universitario de Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hospital Universitario Virgen Del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

University Hospitals Bristol NHS

City

Bristol

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Royal Free Hampstead NHS Trust

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35622074

Citation

Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

Results Reference

derived

PubMed Identifier

31648325

Citation

Gokbuget N, Kantarjian HM, Bruggemann M, Stein AS, Bargou RC, Dombret H, Fielding AK, Heffner L, Rigal-Huguet F, Litzow M, O'Brien S, Zugmaier G, Gao S, Nagorsen D, Forman SJ, Topp MS. Molecular response with blinatumomab in relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Blood Adv. 2019 Oct 22;3(20):3033-3037. doi: 10.1182/bloodadvances.2019000457.

Results Reference

derived

PubMed Identifier

28922466

Citation

Zhu M, Kratzer A, Johnson J, Holland C, Brandl C, Singh I, Wolf A, Doshi S. Blinatumomab Pharmacodynamics and Exposure-Response Relationships in Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Pharmacol. 2018 Feb;58(2):168-179. doi: 10.1002/jcph.1006. Epub 2017 Sep 18.

Results Reference

derived

PubMed Identifier

27873237

Citation

Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

Results Reference

derived

PubMed Identifier

27209293

Citation

Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

Results Reference

derived

PubMed Identifier

25524800

Citation

Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foa R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Bruggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158.

Results Reference

derived

Learn more about this trial

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

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