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Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Primary Purpose

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Blinatumomab

Standard of Care Chemotherapy

About this trial

This is an interventional treatment trial for Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia focused on measuring Relapsed; Refractory; B-precursor; Acute Lymphoblastic Leukemia; Philadelphia Negative; ALL; Blinatumomab; Leukemia; Standard of Care; SOC

Eligibility Criteria

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

Subjects with Philadelphia negative B-precursor ALL, with any of the following:
- refractory to primary induction therapy or refractory to salvage therapy,
- in untreated first relapse with first remission duration <12 months
- in untreated second or greater relapse
- relapse at any time after allogeneic HSCT
Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
Greater than 5% blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease
Diagnosis of Burkitt's leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder
Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
Isolated extramedullary disease
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blinatumomab

Standard of Care Chemotherapy

Arm Description

Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.

Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months.

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.

Secondary Outcome Measures

Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation

Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy.

Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation

Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl. Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl. Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both).

Event Free Survival (EFS)

Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date. A relapse event was any one of the following: Hematological relapse: proportion of blasts in bone marrow >5% or blasts in peripheral blood after documented CR or CRh* or CRi Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria. The Kaplan-Meier estimate of EFS at 6 months is reported.

Duration of Complete Remission

Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.

Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi)

Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.

Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation

Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry.

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Number of Participants With Adverse Events

Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?

100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants 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.

Number of Participants With Anti-blinatumomab Antibodies

Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay).

Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items. The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL. Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date.

Full Information

NCT ID

NCT02013167

First Posted

December 3, 2013

Last Updated

January 4, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02013167

Brief Title

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Official Title

A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Study Start Date

January 3, 2014 (Actual)

Primary Completion Date

December 29, 2015 (Actual)

Study Completion Date

March 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.

Detailed Description

Adults with relapsed/refractory B-cell precursor ALL were randomized in a 2:1 ratio to receive blinatumomab or 1 of 4 pre-specified, investigator-chosen, SOC chemotherapy regimens. Randomization was stratified by age (< 35 years vs ≥ 35 years of age), prior salvage therapy (yes vs no), and prior allogeneic HSCT (yes vs no) as assessed at the time of consent. The study consisted of up to a 3-week screening and pre-phase period, a treatment period consisting of induction with 2 cycles of either blinatumomab or SOC chemotherapy, a consolidation phase of up to 3 additional cycles of protocol-specified therapy, and a maintenance phase for up to an additional 12 months with protocol-specified therapy. A safety follow-up visit 30 days after the last dose of protocol-specified therapy and a long-term follow-up period were included. The long-term follow-up part of the study was discontinued prematurely based on a recommendation from the data monitoring committee (DMC) that the study be stopped for benefit.

6. Conditions and Keywords

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

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Keywords

Relapsed; Refractory; B-precursor; Acute Lymphoblastic Leukemia; Philadelphia Negative; ALL; Blinatumomab; Leukemia; Standard of Care; SOC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

405 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blinatumomab

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care Chemotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Blinatumomab

Other Intervention Name(s)

Blincyto®, AMG 103, MT103

Intervention Description

Blinatumomab is administered as a continuous intravenous infusion (CIV).

Intervention Type

Drug

Intervention Name(s)

Standard of Care Chemotherapy

Intervention Description

FLAG (fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor) ± anthracycline-based regimen (e.g. idarubicin 10 mg/m² days 1 & 3; fludarabine 30 mg/m² days 1-5; cytarabine arabinoside 2 g/m² days 1-5). Patients > 60 years: Idarubicin 5 mg/m² day 1 & 3; fludarabine 20 mg/m² day 1-5; cytarabine arabinoside 1 g/m² day 1-5 HiDAC (high-dose cytarabine arabinoside) - based regimen ≥1 g/m²/day ± anthracycline and/or in combination with other drugs such as native Escherichia coli asparaginase, polyethylene glycol linked to asparaginase (PEG-asparaginase), vinca alkaloids, steroids, etoposide or alkylating agents High-dose methotrexate-based regimen (HDMTX; 500 mg/m² to 3 g/m² infused up to 24 hours) in combination with native E. coli asparaginase, PEG-asparaginase, vinca alkaloids, steroids, etoposide or alkylating agents. Clofarabine as a single agent as recommended in the prescribing information or clofarabine-based regimens with 20 mg/m²/day for up to 5 days.

Primary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.

Time Frame

From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.

Secondary Outcome Measure Information:

Title

Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation

Description

Time Frame

12 weeks

Title

Description

Time Frame

12 weeks

Title

Event Free Survival (EFS)

Description

Time Frame

6 months

Title

Duration of Complete Remission

Description

Time Frame

Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group.

Title

Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi)

Description

Time Frame

Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group.

Title

Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation

Description

Time Frame

12 weeks

Title

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Time Frame

Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months.

Title

Number of Participants With Adverse Events

Description

Time Frame

From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.

Title

100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

Description

Time Frame

100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016

Title

Number of Participants With Anti-blinatumomab Antibodies

Description

Time Frame

Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days).

Title

Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death

Description

Time Frame

From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Subjects with Philadelphia negative B-precursor ALL, with any of the following: refractory to primary induction therapy or refractory to salvage therapy, in untreated first relapse with first remission duration <12 months in untreated second or greater relapse relapse at any time after allogeneic HSCT Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy. Greater than 5% blasts in the bone marrow Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease Diagnosis of Burkitt's leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement Isolated extramedullary disease Current autoimmune disease or history of autoimmune disease with potential CNS involvement Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert) Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Research Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Research Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Research Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Research Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Research Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Research Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Research Site

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Research Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Research Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Research Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Research Site

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Research Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 20

Country

Czechia

Facility Name

Research Site

City

Creteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Research Site

City

Le Chesnay

ZIP/Postal Code

78157

Country

France

Facility Name

Research Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Research Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Research Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Research Site

City

Pierre-Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Research Site

City

Kiel

ZIP/Postal Code

24116

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Research Site

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Research Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Research Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Ioannina

ZIP/Postal Code

45110

Country

Greece

Facility Name

Research Site

City

Patra

ZIP/Postal Code

26500

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Research Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Research Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Research Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Research Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Research Site

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Research Site

City

Venezia

ZIP/Postal Code

30174

Country

Italy

Facility Name

Research Site

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Research Site

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Research Site

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Research Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Research Site

City

Salamanca

State/Province

Castilla León

ZIP/Postal Code

37007

Country

Spain

Facility Name

Research Site

City

Badalona

State/Province

Cataluña

ZIP/Postal Code

08916

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

ChangHua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Research Site

City

Bristol

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW3 2PF

Country

United Kingdom

Facility Name

Research Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Research Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Research Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Research Site

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28631497

Citation

Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, Cong Z, Hechmati G, Stein A. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017 Sep;20(9):911-922. doi: 10.1080/13696998.2017.1344127. Epub 2017 Jul 11.

Results Reference

background

PubMed Identifier

28249141

Citation

Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foa R, Bassan R, Arslan O, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Bruggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.

Results Reference

background

PubMed Identifier

30947585

Citation

Dombret H, Topp MS, Schuh AC, Wei AH, Durrant S, Bacon CL, Tran Q, Zimmerman Z, Kantarjian H. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019 Sep;60(9):2214-2222. doi: 10.1080/10428194.2019.1576872. Epub 2019 Apr 5.

Results Reference

background

PubMed Identifier

30645768

Citation

Kuchimanchi M, Zhu M, Clements JD, Doshi S. Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. Br J Clin Pharmacol. 2019 Apr;85(4):807-817. doi: 10.1111/bcp.13864. Epub 2019 Feb 18.

Results Reference

background

PubMed Identifier

29954814

Citation

Stein AS, Larson RA, Schuh AC, Stevenson W, Lech-Maranda E, Tran Q, Zimmerman Z, Kormany W, Topp MS. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. Blood Adv. 2018 Jul 10;2(13):1522-1531. doi: 10.1182/bloodadvances.2018019034.

Results Reference

background

PubMed Identifier

29739753

Citation

Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, Franklin J, Tran Q, Cong Z, Schuh AC. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018 Jun 28;131(26):2906-2914. doi: 10.1182/blood-2017-09-804658. Epub 2018 May 8.

Results Reference

background

PubMed Identifier

34830762

Citation

Kantarjian HM, Zugmaier G, Bruggemann M, Wood BL, Horst HA, Zeng Y, Martinelli G. Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. Cancers (Basel). 2021 Nov 9;13(22):5607. doi: 10.3390/cancers13225607.

Results Reference

background

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

34161631

Citation

Jabbour E, Patel K, Jain N, Duose D, Luthra R, Short NJ, Zugmaier G, San Lucas A, Velasco K, Tran Q, Zaman F, Konopleva M, Kantarjian H. Impact of Philadelphia chromosome-like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study. Am J Hematol. 2021 Oct 1;96(10):E379-E383. doi: 10.1002/ajh.26281. Epub 2021 Jul 7. No abstract available.

Results Reference

derived

PubMed Identifier

33542479

Citation

Wei AH, Ribera JM, Larson RA, Ritchie D, Ghobadi A, Chen Y, Anderson A, Dos Santos CE, Franklin J, Kantarjian H. Biomarkers associated with blinatumomab outcomes in acute lymphoblastic leukemia. Leukemia. 2021 Aug;35(8):2220-2231. doi: 10.1038/s41375-020-01089-x. Epub 2021 Feb 4.

Results Reference

derived

PubMed Identifier

32289160

Citation

Rambaldi A, Huguet F, Zak P, Cannell P, Tran Q, Franklin J, Topp MS. Blinatumomab consolidation and maintenance therapy in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia. Blood Adv. 2020 Apr 14;4(7):1518-1525. doi: 10.1182/bloodadvances.2019000874.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

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Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial