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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • PDCy

    Drug

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

  • Non Cy

    Drug

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: PDCy groupOther 1 intervention
Group B: Non Cy groupOther 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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