Back to resultsBlinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
Primary Purpose
Relapsed/Refractory Philadelphia Positive B-precursor ALL
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Philadelphia Positive B-precursor ALL focused on measuring Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;
Eligibility Criteria
Inclusion Criteria
Patients with Ph+ B-precursor ALL, with any of the following:
- Relapsed or refractory to at least one second generation tyrosine kinase inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)
- OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
- Greater than 5% blasts in bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years of age, at the time of informed consent.
- Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Exclusion Criteria
- History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease
- History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis
- Active ALL in the CNS or testes
- Isolated extramedullary disease
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment
- Active acute or extensive chronic graft-versus-host disease (GvHD) which included the administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks before blinatumomab treatment
- immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic HSCT at the time of enrollment.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blinatumomab
Arm Description
Participants will receive blinatumomab by continuous intravenous (CIVI) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieve a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose will be 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 for all subsequent cycles of treatment.
Outcomes
Primary Outcome Measures
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles
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 meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow
no evidence of disease
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Secondary Outcome Measures
Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment
Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR).
An MRD response was defined as MRD < 10^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders.
Duration of CR or CRh* Response
Duration of response was measured for participants in remission (CR/CRh*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm 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.
Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles
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 meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles
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 with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles
Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Overall Survival
Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up.
Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive.
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission
Participants who achieved remission (CR/CRh*) during the first 2 cycles of treatment and received an allogeneic HSCT.
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 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 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?
Number of Participants Who Developed Anti-blinatumomab Antibodies
Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.
Steady State Concentration of Blinatumomab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02000427
Brief Title
Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
Official Title
A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2014 (Actual)
Primary Completion Date
May 20, 2015 (Actual)
Study Completion Date
January 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
Detailed Description
This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, participants will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Philadelphia Positive B-precursor ALL
Keywords
Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blinatumomab
Arm Type
Experimental
Arm Description
Participants will receive blinatumomab by continuous intravenous (CIVI) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieve a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose will be 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 for all subsequent cycles of treatment.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
Blincyto®, AMG 103
Intervention Description
Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles
Description
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 meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow
no evidence of disease
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Time Frame
Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Secondary Outcome Measure Information:
Title
Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment
Description
Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR).
An MRD response was defined as MRD < 10^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders.
Time Frame
Approximately 12 weeks
Title
Duration of CR or CRh* Response
Description
Duration of response was measured for participants in remission (CR/CRh*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm 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.
Time Frame
Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months
Title
Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles
Description
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 meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Time Frame
Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Title
Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles
Description
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 with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Time Frame
Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Title
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles
Description
Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts.
Complete remission was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.
Complete remission with partial hematological recovery was defined as meeting the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.
Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria:
less than or equal to 5% blasts in the bone marrow;
no evidence of disease;
incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000/μl.
Participants without a post-baseline disease assessment were considered non-responders.
Time Frame
Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Title
Overall Survival
Description
Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up.
Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive.
Time Frame
From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.
Title
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission
Description
Participants who achieved remission (CR/CRh*) during the first 2 cycles of treatment and received an allogeneic HSCT.
Time Frame
Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.
Title
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
Description
The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 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.
Time Frame
From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months.
Title
Number of Participants With Adverse Events
Description
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?
Time Frame
From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.
Title
Number of Participants Who Developed Anti-blinatumomab Antibodies
Description
Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.
Time Frame
Day 29 of each treatment period and 30 days after the last dose
Title
Steady State Concentration of Blinatumomab
Time Frame
Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients with Ph+ B-precursor ALL, with any of the following:
Relapsed or refractory to at least one second generation tyrosine kinase inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)
OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
Greater than 5% blasts in bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Age ≥ 18 years of age, at the time of informed consent.
Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Exclusion Criteria
History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease
History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis
Active ALL in the CNS or testes
Isolated extramedullary disease
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment
Active acute or extensive chronic graft-versus-host disease (GvHD) which included the administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks before blinatumomab treatment
immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic HSCT at the time of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
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
La Jolla
State/Province
California
ZIP/Postal Code
92093-0960
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
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
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
45122
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
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
Roma
ZIP/Postal Code
00161
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
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28355115
Citation
Martinelli G, Boissel N, Chevallier P, Ottmann O, Gokbuget N, Topp MS, Fielding AK, Rambaldi A, Ritchie EK, Papayannidis C, Sterling LR, Benjamin J, Stein A. Complete Hematologic and Molecular Response in Adult Patients With Relapsed/Refractory Philadelphia Chromosome-Positive B-Precursor Acute Lymphoblastic Leukemia Following Treatment With Blinatumomab: Results From a Phase II, Single-Arm, Multicenter Study. J Clin Oncol. 2017 Jun 1;35(16):1795-1802. doi: 10.1200/JCO.2016.69.3531. Epub 2017 Mar 29. Erratum In: J Clin Oncol. 2017 Aug 10;35(23):2722. J Clin Oncol. 2017 Aug 20;35(24):2856.
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
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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
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PubMed Identifier
31679130
Citation
Clements JD, Zhu M, Kuchimanchi M, Terminello B, Doshi S. Population Pharmacokinetics of Blinatumomab in Pediatric and Adult Patients with Hematological Malignancies. Clin Pharmacokinet. 2020 Apr;59(4):463-474. doi: 10.1007/s40262-019-00823-8.
Results Reference
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PubMed Identifier
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Citation
Martinelli G, Boissel N, Chevallier P, Ottmann O, Gokbuget N, Rambaldi A, Ritchie EK, Papayannidis C, Tuglus CA, Morris JD, Stein A. Long-term follow-up of blinatumomab in patients with relapsed/refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukaemia: Final analysis of ALCANTARA study. Eur J Cancer. 2021 Mar;146:107-114. doi: 10.1016/j.ejca.2020.12.022. Epub 2021 Feb 13.
Results Reference
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PubMed Identifier
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Citation
Topp MS, Stein AS, Gokbuget N, Horst HA, Boissel N, Martinelli G, Kantarjian H, Bruggemann M, Chen Y, Zugmaier G. Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia: Results of a pooled analysis. Cancer Med. 2021 Apr;10(8):2601-2610. doi: 10.1002/cam4.3731. Epub 2021 Mar 18.
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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
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
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