LinperlisibNCT07900282
Low-Dose Linperlisib Achieves Rapid Hematological Response in a Patient With Pure Red Cell Aplasia and Moderate-to-Severe Renal Insufficiency: A Case Report
An observational study of Linperlisib and PRCA, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This article reports a case of a 70-year-old male patient diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA) complicated by moderate-to-severe renal insufficiency. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Linperlisib, PRCA, Moderate-to-Severe Renal Insufficiency
- What is being tested?
- linperlisib
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A 70-year-old male patient diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA) complicated by moderate-to-severe renal insufficiency
Who may be able to join
- People who diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA).
- People who treatmented by linperlisib.
Who cannot join
- People who refuse to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
This article reports a case of a 70-year-old male patient diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA) complicated by moderate-to-severe renal insufficiency. The patient was refractory or intolerant to multiple prior treatment lines, including cyclosporine A, tacrolimus plus prednisone, sirolimus, and cyclophosphamide, and was transfusion-dependent. In this case,we choose the low-dose linperlisib.
- Conditions
- Linperlisib, PRCA, Moderate-to-Severe Renal Insufficiency
- Being tested
- linperlisib
- Keywords
- linperlisib, PRCA, Moderate-to-Severe Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linperlisibDrug
linperlisib 20mg qd
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin
unit of measure：concentration of HGB（g/L）；measurement tool：physiological parameter（man≥120g/L，female≥110g/L）
Measured: 2、4、8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start31 Jan 2026
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LinperlisibStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Miao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900282
- Sponsor's protocol ID
- linperlisib-case
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Linperlisib Achieves Rapid Hematological Response in a Patient With Pure Red Cell Aplasia and Moderate-to-Severe Renal Insufficiency: A Case Report
- ClinicalTrials.gov ID
- NCT07900282
- Acronym / sponsor ID
- linperlisib-case
- Conditions
- Linperlisib, PRCA, Moderate-to-Severe Renal Insufficiency
- Keywords
- linperlisib, PRCA, Moderate-to-Severe Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This article reports a case of a 70-year-old male patient diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA) complicated by moderate-to-severe renal insufficiency. The patient was refractory or intolerant to multiple prior treatment lines, including cyclosporine A, tacrolimus plus prednisone, sirolimus, and cyclophosphamide, and was transfusion-dependent. In this case,we choose the low-dose linperlisib.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A 70-year-old male patient diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA) complicated by moderate-to-severe renal insufficiency
Key inclusion criteria (2 listed)
- People who diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL)-associated pure red cell aplasia (PRCA).
- People who treatmented by linperlisib.
Key exclusion criteria (1 listed)
- People who refuse to sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linperlisiblinperlisib 20mg qd | Drug | – |
Primary outcome
hemoglobin
Time frame: 2、4、8weeks
unit of measure：concentration of HGB（g/L）；measurement tool：physiological parameter（man≥120g/L，female≥110g/L）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Linperlisib
Active, not recruitingPhase 1/2
Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
Peripheral T-cell Lymphoma
RecruitingPhase 1/2
Linperlisib Combined With Chidamide in Patients With PTCL
Peripheral T-cell Lymphoma
Not yet recruitingPhase 1/2
Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma
Peripheral T Cell Lymphoma
RecruitingPhase 2
Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
Non-Hodgkin Lymphoma
Not yet recruitingPhase 1/2
Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
Peripheral T Cells Lymphoma (PTCL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Linperlisib and PRCA, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin (time frame: 2、4、8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.