Phase 2 Leukaemia Trial, Recruiting NCT06224257 Sponsor: Institute of Hematology & Blood Diseases Hospital, China Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06224257
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have been diagnosed with T-cell large granular lymphocytic leukemia (T-LGLL), a rare type of blood cancer
  • People who meet at least one of the following reasons for needing treatment: low red blood cell levels or dependence on blood transfusions; very low white blood cell counts or frequent infections due to low white blood cell counts; an enlarged spleen that is growing or very large; an autoimmune disease (such as rheumatoid arthritis or autoimmune thyroid disease) that also requires treatment; or severe symptoms such as significant weight loss, drenching night sweats, or persistent fever
  • People whose condition did not respond to, or who could not tolerate, a first course of standard treatment
  • People who are well enough to carry out basic daily activities (based on a standard medical scoring system, this means scoring 0, 1, or 2 on the ECOG scale — confirm with trial site)
  • People whose life expectancy is at least 6 months
  • People who are willing and able to follow the study requirements and who have signed a written consent form

Who may not be able to join:

  • People who have a history of other blood or lymph node cancers
  • People who have had a malignant (cancerous) tumour within the past 5 years — exceptions may apply for certain fully cured, low-risk skin cancers or similarly treated early-stage cancers (confirm with trial site)
  • People who have previously had an organ transplant or a stem cell transplant
  • People who have had an active infection in the 2 weeks before starting the trial medication
  • People who have hepatitis B, hepatitis C, HIV, or any other ongoing infection that requires treatment
  • People with a history of a weakened immune system or a condition they were born with that affects the immune system
  • People with serious or uncontrolled health conditions, including significant heart disease, high blood pressure that cannot be controlled, major metabolic disorders, or conditions that seriously affect the stomach or digestive system
  • People whose liver function tests (specifically ALT and AST levels) are more than 2.5 times higher than the normal range, confirmed on two separate tests at least one week apart
  • People with significantly reduced kidney function (a creatinine clearance measurement below 30 ml/min — confirm with trial site)
  • People with a history of a mental illness
  • People with a history of certain lung conditions, including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-related lung damage, drug-related lung damage, or severely reduced lung function
  • People who have received a live (attenuated) vaccine within 4 weeks before joining the trial
  • People who have taken part in another clinical trial within 4 weeks before the start of this trial
  • People who have a known allergy to Linperlisib or any of its ingredients
  • People who are pregnant or breastfeeding
  • People whom the trial doctor considers unsuitable for the study for other medical reasons

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jun Shi, PhD, Institute of Hematology & Blood Diseases Hospital, China

Phone: 13752253515

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Registry
ClinicalTrials.gov
Start date
3 December 2023
Est. completion
31 October 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of patients with hematologic remission

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov