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Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment (BID-PERAL)

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ClinicalTrials.gov Identifier: NCT04423367
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Shi, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
This is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.

Condition or disease Intervention/treatment Phase
Acquired Pure Red Cell Aplasia Drug: bortezomib/dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial
Actual Study Start Date : September 13, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : September 30, 2023


Arm Intervention/treatment
Experimental: bortezomib/dexamethasone
Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.
Drug: bortezomib/dexamethasone
Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: within 12 weeks ]

Secondary Outcome Measures :
  1. Frequency and severity of adverse events and severe adverse events [ Time Frame: within 12 weeks ]
  2. Relapse free survival [ Time Frame: within 24 and 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG ≤ 2.
  • Age from 18 to 70.
  • Diagnosed with acquired pure red cell aplasia.
  • Meets the criteria of first-line treatment failure or relapse.
  • Organs in good function.
  • Signed informed consent.

Exclusion Criteria:

  • Nursing woman.
  • Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc.
  • Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc.
  • Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma.
  • Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation.
  • Secondary PRCA caused by solid tumors except for thymoma.
  • Secondary PRCA caused by drugs or pregnancy.
  • Secondary PRCA caused by the B19 virus.
  • Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities.
  • Previously received treatment in other trials within 4 weeks before enrollment.
  • Previously treated with the proteasome inhibitor.
  • Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment.
  • Have a history of malignant tumors.
  • Have a history of mental illness.
  • Inability to understand or to follow study procedures.

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): NCT04423367


Contacts
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Contact: Jun Shi, PhD (86)2223900913 shijun@ihcams.ac.cn
Contact: Lele Zhang, MD (86)15811139278 zhanglele@ihcams.ac.cn

Locations
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China
Regenerative Medicine Center Recruiting
Tianjin, China
Contact: Jun Shi, PhD    (86)2223900913    shijun@ihcams.ac.cn   
Contact: Jingyu Zhao, MPH    (86)13752253515    zhaojingyu@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Jun Shi, PhD Institute of Hematology & Blood Diseases Hospital
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Responsible Party: Jun Shi, Director, Regenerative Medicine Clinic Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04423367    
Other Study ID Numbers: IHBDH-IIT2020010
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jun Shi, Institute of Hematology & Blood Diseases Hospital:
Acquired Pure Red Cell Aplasia
PRCA
Failure or Relapse after First-line Treatment
Additional relevant MeSH terms:
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Red-Cell Aplasia, Pure
Recurrence
Disease Attributes
Pathologic Processes
Anemia
Hematologic Diseases
Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents