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Trial record 1 of 108 for:    ALCANTARA study
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Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02000427
First received: November 15, 2013
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Relapsed/Refractory Philadelphia Positive B-precursor ALL Drug: Blinatumomab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants with CR/CRh* within 2 cycles of treatment with blinatumomab [ Time Frame: Approximately 12 weeks ]

Secondary Outcome Measures:
  • Number of Participants with MRD remission within 2 cycles of treatment with blinatumomab [ Time Frame: Approximately 12 weeks ]
  • Duration of CR or CRh* [ Time Frame: Approximately 3 - 4 years ]
  • Number of Participants with CR within 2 cycles of treatment with blinatumomab [ Time Frame: Approximately 12 weeks ]
  • Number of Participants with CRh* rate within 2 cycles of treatment with blinatumomab [ Time Frame: Approximately 12 weeks ]
  • Number of Participants with CR+CRh*+ Complete Response incomplete (CRi) rate within 2 cycles of treatment with blinatumomab [ Time Frame: Approximately 12 weeks ]
  • Overall survival [ Time Frame: Approximately 3 - 4 years ]
  • Number of Participants undergoing Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) and 100-day mortality after alloHSCT [ Time Frame: 100 days ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability and number of participants withIncidence of adverse events and antibody formation [ Time Frame: Approximately 2 - 3 years ]
  • Serum concentration of blinatumomab [ Time Frame: Approximately 2 - 3 years ]

Enrollment: 45
Actual Study Start Date: January 3, 2014
Study Completion Date: January 6, 2017
Primary Completion Date: May 20, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blinatumomab

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.

Drug: Blinatumomab
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.
Other Names:
  • Blincyto®
  • AMG 103

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000427

Locations
United States, California
Research Site
Duarte, California, United States, 91010
Research Site
La Jolla, California, United States, 92093-0960
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site
New York, New York, United States, 10065
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Texas
Research Site
Houston, Texas, United States, 77030
France
Research Site
Nantes Cedex 1, France, 44093
Research Site
Paris Cedex 10, France, 75475
Research Site
Toulouse cedex 9, France, 31059
Germany
Research Site
Berlin, Germany, 12200
Research Site
Essen, Germany, 45122
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Würzburg, Germany, 97080
Italy
Research Site
Bergamo, Italy, 24127
Research Site
Bologna, Italy, 40138
Research Site
Roma, Italy, 00161
Research Site
Venezia, Italy, 30174
Research Site
Verona, Italy, 37134
United Kingdom
Research Site
London, United Kingdom, NW3 2PF
Research Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02000427     History of Changes
Other Study ID Numbers: 20120216
2006-006520-19 ( EudraCT Number )
Study First Received: November 15, 2013
Last Updated: June 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blinatumomab
Antibodies, Bispecific
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017