BridgeMD
New treatment option for Hematological Malignancy
Official title Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors
ClinicalTrials.gov ID: NCT06584006
What this study is testing
What is Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections?
Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for hematological malignancy.
Also referred to as Combination Therapy Group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
- Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
- Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
- Estimated creatinine clearance rate ≥ 30 mL/min.
- AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
You likely can't join if
- Active autoimmune disease.
- Patients considered to have a malignant T-cell clone.
- Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
- Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \<1.0×10\^9/L, HB\<70g/L, PLT\<50×10\^9/L).
- HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
- Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological...
See the full eligibility criteria
- Patients with histologically confirmed myeloid, B lymphocyte, and plasma cell-derived malignant hematological tumors.
- Lymphocyte count ≤ 0.8×109/L or CD4+T cell count ≤ 0.35×109/L.
- Age ≥ 18 years, both male and female, with an expected survival period of more than 3 months.
- Estimated creatinine clearance rate ≥ 30 mL/min.
- AST and ALT ≤ 3.0 x ULN. Bilirubin ≤ 1.5 x ULN.
- ECOG ≤ 2.
- Able to understand and voluntarily provide informed consent.
- Active autoimmune disease.
- Patients considered to have a malignant T-cell clone.
- Within 8 days after chemotherapy for lymphoma and within 14 days after chemotherapy for AML.
- Tumor involvement in the bone marrow leading to hematopoietic suppression (neutrophils \<1.0×10\^9/L, HB\<70g/L, PLT\<50×10\^9/L).
- HIV-positive patients and/or active HBV or HCV infection (as evidenced by positive HBV-DNA and HCV-RNA test records).
- Patients with chronic respiratory diseases requiring continuous oxygen, or with significant past medical history of kidney, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular diseases.
- Immunosuppressive treatment (such as cyclosporine, corticosteroids, ruxolitinib, JAK1/2 inhibitors, etc.) within the past 5 days.
- Psychiatric disorders that would interfere with study participation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation.
- Consideration of allergy to Thymalfasin or Interleukin-2.
- Any other condition that the researcher believes makes the patient unsuitable for this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.