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Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476239
Recruitment Status : Active, not recruiting
First Posted : March 26, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery [CR/CRh*]) induced by blinatumomab in Chinese adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

The study will consist of a screening period, a treatment period, and a follow-up period.


Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Blinatumomab Phase 3

Detailed Description:

This is an open label, single-arm, multicenter phase 3 study to evaluate efficacy and safety of the BiTE (bispecific T cell engager) antibody blinatumomab in Chinese adult subjects with relapsed/refractory B-precursor ALL. The study will consist of a screening period, a treatment period, and a follow-up period.

Treatment will consist of up to 5 cycles of blinatumomab. Subjects who have achieved a bone marrow (BM) response (≤ 5% BM blasts) or CR/CRh*/CRi within 2 induction cycles of treatment may continue to receive up to 3 additional consolidation cycles of blinatumomab. Thirty days (± 3 days) after end of the last dose of protocol-specified therapy, subjects will have a safety follow-up visit.

If subjects are suitable for alloHSCT after treatment with blinatumomab, they may undergo alloHSCT instead of receiving further consolidation cycles with blinatumomab.

Subjects will be followed via clinic visit or telephone contact every 3 months +/- 1 month after their safety follow-up visit until death has been observed or a maximum of 2 years after start of treatment, whichever occurs first

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Evaluate the efficacy and safety of blinatumomab in Chinese subjects with relapsed/refractory B-precursor ALL, The study will consist of a screening period, a treatment period, and a follow-up period.

Treatment will consist of up to 5 cycles of blinatumomab

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : August 21, 2019
Estimated Study Completion Date : April 25, 2021


Arm Intervention/treatment
Experimental: blinatumomab
Approximately 120 Chinese adult subjects
Drug: Blinatumomab
Blinatumomab is administered as a continuous intravenous infusion (CIVI). A cycle = 6 weeks (4 weeks of blinatumomab treatment, 2-week treatment-free). Treatment will consist of up to 5 cycles of blinatumomab Subjects who have achieved a bone marrow (BM) response or CR/CRh*/CRi within 2 induction cycles of treatment may continue to receive up to 3 additional consolidation cycles of blinatumomab. 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.
Other Names:
  • BLINCYTO®
  • AMG103
  • MT103




Primary Outcome Measures :
  1. Change in rate of hematological response [CR/CRh] induced by blinatumomab [ Time Frame: Within 2 cycles of treatment (6 weeks/cycle) ]

    BM smears (slides) at screening and at the end of each treatment cycle (6 weeks/cycle) will be collected for cytomorphology testing.

    The degree of BM infiltration defined by the percentage of leukemic blasts in BM will be evaluated by local laboratories as per cytological assessment. In addition, the BM slides will be provided to the designated central laboratories for hematological assessment.

    The results of the local laboratory are applicable for inclusion into the study and for the decision if pre-treatment and/or blinatumomab treatment should be administered if the results of the central laboratory are not yet available at the time these decisions are made. For evaluation of baseline and response, the result of the central laboratory will prevail.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

101 Subjects have provided informed consent/assent prior to initiation of any study-specific activities/procedures or subjects legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated 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.

102 Subjects with Ph-negative B-precursor ALL, with any of the following:

  • Primary refractory after induction therapy or who had relapsed within 12 months of first remission or
  • Relapsed within 12 months of receiving alloHSCT or
  • Relapsed or refractory after first salvage therapy or beyond

    103 > 5% blasts in BM (by morphology)

    104 Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

    105 Age ≥ 18 years at the time of informed consent

Exclusion Criteria:

Disease Related

201 Subjects with Ph-positive ALL

202 Subjects with Burkitt´s Leukemia according to World Health Organization (WHO) classification.

203 History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis

204 Active ALL in the CNS (confirmed by cerebrospinal fluid [CSF] analysis) or testes

205 Isolated extramedullary disease

206 Current active autoimmune disease or history of autoimmune disease with potential CNS involvement

Other Medical Conditions

207 History of malignancy other than ALL within 5 years prior to start of protocol-specified therapy with the exception of:

  • Malignancy treated with curative intent and with no known active disease present for 5 years before enrollment and felt to be at low risk for recurrence by the treating physician.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease.
  • Adequately treated breast ductal carcinoma in situ without evidence of disease.
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer.

    208 Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)

Medications or Other Treatments

210 Autologous HSCT within 6 weeks prior to start of blinatumomab treatment

211 AlloHSCT within 3 months prior to start of blinatumomab treatment

212 Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment

213 Any systemic therapy against active GvHD within 2 weeks prior to start of blinatumomab treatment

214 Cancer chemotherapy within 2 weeks prior to start of blinatumomab treatment (intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab treatment). In addition, any subject whose organ toxicity (excluding hematologic) from prior ALL treatment has not resolved to common terminology criteria for adverse events (CTCAE) ≤ grade 1.

215 Radiotherapy within 2 weeks prior to start of blinatumomab treatment

216 Immunotherapy (eg, rituximab) within 4 weeks prior to start of blinatumomab treatment

217 Currently receiving treatment in another investigational device or drug study, or less than 4 weeks prior to start of blinatumomab treatment.

218 Previous treatment with anti-CD19 therapy

General

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

220 Pregnant women and women planning to become pregnant should not participate in this study. Subjects who are breast feeding prior to start of blinatumomab treatment may be enrolled if they stop breast feeding with breast milk produced during blinatumomab treatment and for an additional 48 hours after the last dose of blinatumomab.

222 Male participants are not required to use birth control during treatment with blinatumomab. However, you should let your female partner know you are in this study.

223 Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.

224 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

225 Previous treatment with blinatumomab

226 Abnormal screening laboratory values as defined below:

  • Aspartate aminotransferase (AST) and/or alanine aminotransferase ALT and/or ALP ≥ 5 x upper limit of normal (ULN)
  • Total bilirubin (TBL) ≥ 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
  • Creatinine ≥ 1.5 ULN or creatinine clearance < 60 ml/min (calculated)

    227 Woman of childbearing potential and is not willing to use 2 effective methods of contraception during treatment and for an additional 48 hours after the last dose of blinatumomab. Birth control is not required for postmenopausal women, or women with uterus/or both ovaries/ or both fallopian tubes removed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476239


Locations
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China, Beijing
Research Site
Beijing, Beijing, China, 100191
Research Site
Beijing, Beijing, China, 100730
Research Site
Beijing, Beijing, China, 100853
China, Fujian
Research Site
Fuzhou, Fujian, China, 350001
China, Guangdong
Research Site
Guangzhou, Guangdong, China, 510080
Research Site
Guangzhou, Guangdong, China, 510120
Research Site
Guangzhou, Guangdong, China, 510515
China, Henan
Research Site
Zhengzhou, Henan, China, 450008
China, Hubei
Research Site
Wuhan, Hubei, China, 430030
China, Hunan
Research Site
Changsha, Hunan, China, 410008
China, Jiangsu
Research Site
Nanjing, Jiangsu, China, 210029
Research Site
Suzhou, Jiangsu, China, 215006
China, Jilin
Research Site
Changchun, Jilin, China, 130021
China, Liaoning
Research Site
Shenyang, Liaoning, China, 110001
China, Shaanxi
Research Site
XI An, Shaanxi, China, 71004
China, Sichuan
Research Site
Chengdu, Sichuan, China, 610041
China, Tianjin
Research Site
Tianjin, Tianjin, China, 300020
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China, 310003
Research Site
Hangzhou, Zhejiang, China, 310009
China
Research Site
Beijing, China, 102206
Research Site
Hefei, China, 230001
Research Site
Shanghai, China, 200040
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03476239    
Other Study ID Numbers: 20130316
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Relapsed
Refractory
B-precursor
Acute Lymphoblastic
Leukemia ALL
Blinatumomab
Chinese Adult Subjects
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blinatumomab
Antineoplastic Agents