Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia
Recruiting
Phase 2Interventional Study
Severe Aplastic AnemiaCyclophosphamide Reduced-doseImmunosuppressive Therapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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 …
Inclusion 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.
Exclusion Criteria:
* 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.
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