Trial · NCT06682169
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective remission rate in the 24th week (ORR) | Week 24 | Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined. |
| Secondary | Best Objective Response Rate (BOR) | Week 24 | The best therapeutic effect among all therapeutic outcomes |
| Secondary | Duration of Relief (DOR) | Through study completion, an average of 2 year | The duration of symptom relief for patients after receiving treatment |
| Secondary | Improvement in Lee cGVHD symptom score of subjects in week 24 | Week 24 | The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms. |
| Secondary | Failure free survival (FFS) | Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96 | The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient |
| Secondary | Primary disease recurrence rate (MR) | Weeks 8, 16,24， 36, 48 | The probability of recurrence of the patient's disease within a certain period of time. |
| Secondary | Non-Relapse Mortality (NRM) | Weeks 8, 16,24， 36, 48 | NRM was defined as death without recurrent or progressive disease |
| Secondary | Overall survival (OS) | Through study completion, an average of 2 year | From randomization to the time of death caused by any reason |
| Secondary | Percentage of subjects whose daily glucocorticoid dose decreased | Week 24 | Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids |
| Secondary | Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | Through study completion, an average of 2 year | The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√" |
| Secondary | Changes in 5-level EQ-5D (EQ-5D-5L) | Through study completion, an average of 2 year | The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty) |
| Secondary | Adverse events (AE) | Through study completion, an average of 2 year | The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators. |
| Secondary | Cmax | Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle) | The maximum concentration of medication that enters the bloodstream after administration |
| Secondary | Ctrough | Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle) | After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT06682169/registered