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Not yet recruitingNCT06490562Updated Jul 8, 2024

Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI

An interventional study of PDCy and Non Cy in Acute Graft-versus-host Disease, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Sex
All
01

Study 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 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. 1-year overall survival rate (OS);
  2. 1-year recurrence rate (CIR);
  3. 1-year non recurrent mortality rate (NRM);
  4. 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);
  5. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.
02

Conditions studied

  • Acute Graft-versus-host Disease

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's planned enrollment of 66 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects eligible for inclusion in this study must meet all of the following criteria:

    1. Patients with malignant hematological diseases undergo haploid/sibling incomplete matching/unrelated donor transplantation;
    2. Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);
    3. Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;
    4. No age, gender, or race restrictions;
    5. The physical condition assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;
    6. The patient or their authorized representative agrees to participate in the clinical trial and signs an informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria are not eligible for inclusion in this study:

    1. Siblings of matched donor transplant;
    2. Patients with other malignant tumors that require treatment;
    3. There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;
    4. HIV serological reaction was positive;
    5. Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;
    6. Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;

    7. Active heart disease is defined as one or more of the following:

      1. Have a history of uncontrolled or symptomatic angina pectoris;
      2. Myocardial infarction less than 6 months prior to enrollment in the study;
      3. A history of arrhythmia requiring medication treatment or severe clinical symptoms;
      4. Uncontrolled or symptomatic congestive heart failure (\>NYHA level 2);
      5. The ejection fraction is below the lower limit of the normal range.
    8. Individuals who are allergic to any medication or component such as Cy, CNI, etc;
    9. The researchers believe that it is not suitable for participants.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Other
    PDCy group

    Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD

    Drug: PDCy

  • Other
    Non Cy group

    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

    Drug: Non Cy

Interventions

  • DrugPDCy

    Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD

  • DrugNon Cy

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Until the end of the study

Secondary outcomes

  1. 1-year overall survival rate (OS)

    1-year overall survival rate (OS)

    Time frame: 1 year after the last patient was enrolled

  2. 1-year recurrence rate (CIR)

    1-year recurrence rate (CIR)

    Time frame: 1 year after the last patient was enrolled

  3. 1-year non recurrent mortality rate (NRM)

    1-year non recurrent mortality rate (NRM)

    Time frame: 1 year after the last patient was enrolled

  4. 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)

    Time frame: 1 year after the last patient was enrolled

  5. 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

    Time frame: 1 year after the last patient was enrolled

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06490562
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Jul 8, 2024
Start date
Jul 2024 (estimated)
Primary completion
May 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 8, 2024

Study contacts

erlie jiang, MD
Contact
jiangerlie@ihcams.ac.cn
+86-15122538106

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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