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

NCT06490562 | Not Yet Recruiting

• 1 other identifier: IIT2024034
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Graft-versus-host Disease

Outcome Measures

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.

  Until the end of the study

Secondary Outcomes (5)

• 1-year overall survival rate (OS)

  1 year after the last patient was enrolled

• 1-year recurrence rate (CIR)

  1 year after the last patient was enrolled

• 1-year non recurrent mortality rate (NRM)

  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)

  1 year after the last patient was enrolled

• The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.

  1 year after the last patient was enrolled

Study Arms (2)

PDCy group

OTHER

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

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

Drug: Non Cy

Interventions

PDCy DRUG

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

PDCy group

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

Non Cy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Central Study Contacts

erlie jiang, MD

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 8, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 8, 2024

Record last verified: 2024-05