Acute Graft-versus-host DiseaseNCT06490562
Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
A study testing PDCy and Non Cy in people with Acute Graft-versus-host Disease, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Graft-versus-host Disease
- What is being tested?
- PDCy and Non Cy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects eligible for inclusion in this study must meet all of the following criteria:
- Patients with malignant hematological diseases undergo haploid/sibling incomplete matching/unrelated donor transplantation;
- Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);
- Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;
- No age, gender, or race restrictions;
- The physical condition assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
- The patient or their authorized representative agrees to participate in the clinical trial and signs an informed consent form.
Who cannot join
- Subjects meeting any of the following criteria are not eligible for inclusion in this study:
- Siblings of matched donor transplant;
- Patients with other malignant tumors that require treatment;
- There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;
- HIV serological reaction was positive;
- Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;
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- Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;
- Active heart disease is defined as one or more of the following:
- Have a history of uncontrolled or symptomatic angina pectoris;
- Myocardial infarction less than 6 months prior to enrollment in the study;
- A history of arrhythmia requiring medication treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\>NYHA level 2);
- The ejection fraction is below the lower limit of the normal range.
- Individuals who are allergic to any medication or component such as Cy, CNI, etc;
- The researchers believe that it is not suitable for participants.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicenter Randomized Controlled Clinical Trial Protocol for the Efficacy and Safety of Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Read the detailed description
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Efficacy Evaluation: Follow up observation of the difference in efficacy and safety between two groups in preventing severe (III-IV) aGVHD.
Primary Exploratory Endpoint: Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Secondary Exploratory Endpoints:
- 1-year overall survival rate (OS);
- 1-year recurrence rate (CIR);
- 1-year non recurrent mortality rate (NRM);
- The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD);
- The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
- Conditions
- Acute Graft-versus-host Disease
- Being tested
- PDCy, Non Cy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDCyDrug
Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD
Non CyDrug
Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI
| Study group | Role | What they receive |
|---|---|---|
| PDCy group | Other | Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD Receives: Drug: PDCy |
| Non Cy group | Other | Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI Receives: Drug: Non Cy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Measured: Until the end of the study
Secondary outcomes (5)
1-year overall survival rate (OS)
1-year overall survival rate (OS)
Measured: 1 year after the last patient was enrolled
1-year recurrence rate (CIR)
1-year recurrence rate (CIR)
Measured: 1 year after the last patient was enrolled
1-year non recurrent mortality rate (NRM)
1-year non recurrent mortality rate (NRM)
Measured: 1 year after the last patient was enrolled
The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD)
The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD)
Measured: 1 year after the last patient was enrolled
The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac
Measured: 1 year after the last patient was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490562
- Sponsor's protocol ID
- IIT2024034
- Status last verified
- May 2024
- First submitted
- 19 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Clinical Trial Protocol for the Efficacy and Safety of Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI
- ClinicalTrials.gov ID
- NCT06490562
- Acronym / sponsor ID
- IIT2024034
- Conditions
- Acute Graft-versus-host Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jul 2024 (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.
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Detailed description
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Efficacy Evaluation: Follow up observation of the difference in efficacy and safety between two groups in preventing severe (III-IV) aGVHD.
Primary Exploratory Endpoint: Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Secondary Exploratory Endpoints:
- 1-year overall survival rate (OS);
- 1-year recurrence rate (CIR);
- 1-year non recurrent mortality rate (NRM);
- The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD);
- The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDCy group | Other | Drug: PDCyLow dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD |
| Non Cy group | Other | Drug: Non CyOral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects eligible for inclusion in this study must meet all of the following criteria:
Key exclusion criteria (15 listed)
- Subjects meeting any of the following criteria are not eligible for inclusion in this study:
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 |
|---|---|---|
| PDCyLow dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD | Drug | PDCy group |
| Non CyOral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI | Drug | Non Cy group |
Primary outcome
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
Time frame: Until the end of the study
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI.
5 secondary outcomes
1-year overall survival rate (OS)
Time frame: 1 year after the last patient was enrolled
1-year recurrence rate (CIR)
Time frame: 1 year after the last patient was enrolled
1-year non recurrent mortality rate (NRM)
Time frame: 1 year after the last patient was enrolled
The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrent minimal residual disease (MRD)
Time frame: 1 year after the last patient was enrolled
The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
Time frame: 1 year after the last patient was enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PDCy and Non Cy in people with Acute Graft-versus-host Disease, run by Institute of Hematology & Blood Diseases Hospital, 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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang, MD (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used after gDLI. (time frame: Until the end of the study). 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 8 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.