CompletedPhase 1

A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.

China10 participantsStarted 2024-12-04

Plain-language summary

A study to evaluate the safety, efficacy, and pharmacokinetics of MegaLT in treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Who can participate

Age range

4 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 4 and 75 years (inclusive) at screening; gender is not restricted; * Diagnosed with refractory thrombocytopenia following radiotherapy/chemotherapy or transplantation; * Adequate organ function：Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \< 2.5\*upper limit of normal (ULN); Serum creatinine \< 1.5\* ULN; Total bilirubin level \< 1.5\* ULN; Coagulation function: International Normalized Ratio (INR) ≤ 1.5\* ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5\*ULN; Hemoglobin ≥ 60 g/L, or hemoglobin maintained at this level after transfusion; Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form. Exclusion Criteria: * Patients with any malignant tumor relapse; * Pregnant or breastfeeding women; * Life expectancy less than 3 months; * Severe infections or severe concurrent conditions such as heart, liver, lung, kidney, neurological, or metabolic diseases; * History of severe thrombotic events or known thrombotic risk factors. Exceptions: Participants for whom the potential benefits of the study, as determined by the investigator, outweigh the potential risks of thromboembolic events; * Uncontrolled infectious or other serious diseases, including but not limited to infections (e.g., HIV positive), congestive heart fai…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Event(AE)

Timeframe: From the date of initial infusion to 1 year after initial infusion

Incidence of bleeding events

Timeframe: From the date of initial infusion to 1 year after initial infusion

The cumulative incidence and grade of graft-versus-host disease (GVHD) including acute and chronic GVHD

Timeframe: From the date of initial infusion to 1 year after initial infusion

The probability of GVHD-free, relapse-free survival(GRFS)

Timeframe: From the date of initial infusion to 1 year after initial infusion

Overall response rate (ORR)

Timeframe: 4 weeks after initial infusion

Trial details

NCT IDNCT06534255

SponsorAnhui Provincial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Refractory Thrombocytopenia trials

Who can participate

Age range

4 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Adverse Event(AE)

Timeframe: From the date of initial infusion to 1 year after initial infusion

Incidence of bleeding events

Timeframe: From the date of initial infusion to 1 year after initial infusion

The cumulative incidence and grade of graft-versus-host disease (GVHD) including acute and chronic GVHD

Timeframe: From the date of initial infusion to 1 year after initial infusion

The probability of GVHD-free, relapse-free survival(GRFS)

Timeframe: From the date of initial infusion to 1 year after initial infusion

Overall response rate (ORR)

Timeframe: 4 weeks after initial infusion