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Randomized controlled clinical study of immunosurveillance in patients with hematologic tumors to determine the timing of prevention of invasive fungal infections

Randomized controlled clinical study of immunosurveillance in patients with hematologic tumors to determine the timing of prevention of invasive fungal infections

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079810
Enrollment
Unknown
Registered
2024-01-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal infection

Interventions

Treatment group:Fluconazole 200mg
One group of patients with IgG > 7mg/ml or absolute NK cell count > 6.5?10^4/L:non-prophylactic

Sponsors

Huadong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: After autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation or ? after receiving strong cytotoxic drugs (such as high dose of CTX) or ? after a long course of high dose of glucocorticoids (0.5mg/kg predtisone for more than 1 month) or ? after using immunosuppressive drugs such as rituximab, it is necessary to meet that granulocytosis has recovered or no granulocytosis. Patients who do not require fungal prophylaxis according to current guidelines (i.e., patients who have developed grade III to IV graft-versus-host disease during allogeneic hematopoietic stem cell transplantation).

Exclusion criteria

Exclusion criteria: 1)patients with acute myeloid leukemia or other hematological malignancies had granuloidosis for more than one week after chemotherapy. 2)Patients with allogeneic hematopoietic stem cell transplantation who have developed grade III to IV acute graft-versus-host disease need fungal prophylaxis according to guidelines. 3) Participants who have participated in other clinical trials within 30 days. 4) Pregnant and nursing patients. 5) The patient has another type of tumor except superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN), or prostate intraepithelial carcinoma (PIN) 6) Have an active viral or bacterial infection that is not controlled with appropriate anti-infective treatment 7) serologic positive for known HIV or active hepatitis C virus; Patients with active hepatitis B virus, manifested as elevated HBV titer and abnormal liver function, need strict anti-hepatitis B virus treatment, and can be considered for inclusion after hepatitis B virus control (HBV titer decline). Hepatitis B major Sanyang, small sanyang patients, such as HBV-DNA< 500, can be enrolled after regular antiviral treatment. 8) A person with a mental disorder or other condition who is unable to cooperate with the requirements of research treatment and monitoring

Design outcomes

Primary

MeasureTime frame
Immunoglobulin level;Incidence of invasive fungal infections;

Countries

China

Contacts

Public ContactJiexian Ma

Huadong Hospital

jiexianma@hotmal.com+86 137 6452 0566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026