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New treatment option for Severe Aplastic Anemia
Official title Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
ClinicalTrials.gov ID: NCT06695741
What this study is testing
What is Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy?
Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for severe aplastic anemia.
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
- This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Subject has a diagnosis of naïve severe or very severe aplastic anemia
- Male or female age ≥ 12 years
- Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent.
You likely can't join if
- Previously received immunosuppressive therapy \> 4 weeks
- Previously treated with TPO-RA \> 4 weeks
- Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.
- Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless...
- Tested positive for HIV or syphilis
- Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities.
See the full eligibility criteria
- Subject has a diagnosis of naïve severe or very severe aplastic anemia
- Male or female age ≥ 12 years
- Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent.
- Previously received immunosuppressive therapy \> 4 weeks
- Previously treated with TPO-RA \> 4 weeks
- Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.
- Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure.
- Tested positive for HIV or syphilis
- Presence of severe liver, kidney, or heart failure, or other life-threatening comorbidities.
- History of radiotherapy and chemotherapy for malignant solid tumors in recent 5 years
- Combined with other serious disorders
- Pregnant or breast-feeding patients
- Patients considered to be ineligible for the study by the investigator for reasons other than the above.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.