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

Primary Purpose

Acquired Pure Red Cell Aplasia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

bortezomib/dexamethasone

About this trial

This is an interventional treatment trial for Acquired Pure Red Cell Aplasia focused on measuring Acquired Pure Red Cell Aplasia, PRCA, Failure or Relapse after First-line Treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhoukou Central Hospital
The Second Affilated Hospital of Shandong First Medical University
Regenerative Medicine CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bortezomib/dexamethasone

Arm Description

Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Frequency and severity of adverse events and severe adverse events

Relapse free survival

Full Information

NCT ID

NCT04423367

First Posted

June 5, 2020

Last Updated

December 4, 2022

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04423367

Brief Title

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

Acronym

BID-PERAL

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2020 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Acquired Pure Red Cell Aplasia

Keywords

Acquired Pure Red Cell Aplasia, PRCA, Failure or Relapse after First-line Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bortezomib/dexamethasone

Arm Type

Experimental

Arm Description

Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.

Intervention Type

Drug

Intervention Name(s)

bortezomib/dexamethasone

Intervention Description

Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

within 12 weeks

Secondary Outcome Measure Information:

Title

Frequency and severity of adverse events and severe adverse events

Time Frame

within 12 weeks

Title

Relapse free survival

Time Frame

within 24 and 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Shi, PhD

Phone

(86)2223900913

shijun@ihcams.ac.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Lele Zhang, MD

Phone

(86)15811139278

zhanglele@ihcams.ac.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Shi, PhD

Organizational Affiliation

Institute of Hematology & Blood Diseases Hospital, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhoukou Central Hospital

City

Zhoukou

State/Province

Henan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qian Liang, PhD

Phone

15703815972

lqw141230@163.com

Facility Name

The Second Affilated Hospital of Shandong First Medical University

City

Tai'an

State/Province

Shandong

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hong Zhang

Phone

18505386878

tyfyzhh@163.com

Facility Name

Regenerative Medicine Center

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Shi, PhD

Phone

(86)2223900913

shijun@ihcams.ac.cn

First Name & Middle Initial & Last Name & Degree

Jingyu Zhao, MPH

Phone

(86)13752253515

zhaojingyu@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33957358

Citation

Zhang L, Chen N, Xu Z, Liang Q, Pan H, Zhao J, Fang L, Shi J. Good treatment-free survival of monoclonal gammopathy of undetermined significance associated pure red cell aplasia after bortezomib plus dexamethasone. Blood Cells Mol Dis. 2021 Jul;89:102573. doi: 10.1016/j.bcmd.2021.102573. Epub 2021 Apr 27.

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

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