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Methylprednisolone, Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim for Aplastic Anemia or Myelodysplastic Syndrome

This study is testing a combination of medicines for people with aplastic anemia or certain types of myelodysplastic syndrome (MDS). The medicines include methylprednisolone, horse anti-thymocyte globulin, cyclosporine, and either filgrastim or pegfilgrastim. Horse anti-thymocyte globulin targets immune cells called T-lymphocytes, which are thought to cause low blood counts in these conditions. Methylprednisolone and cyclosporine also help suppress immune cells. Filgrastim and pegfilgrastim help white blood cells grow. The goal is to see if this combination improves blood counts. You may be able to join if you have aplastic anemia or low or intermediate-risk MDS, whether you've been treated before or not. The study aims to enroll 140 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 140 participants.
What's involved
You would receive methylprednisolone, horse anti-thymocyte globulin, cyclosporine, and either filgrastim or pegfilgrastim. Treatment continues for up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits every 6-12 months for up to 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01624805

Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~140 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Anti-Thymocyte GlobulinCyclosporineFilgrastimMethylprednisolonePegfilgrastim

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of response
Measured over Up to 6 years

Conditions

Aplastic Anemia
de Novo Myelodysplastic Syndrome
Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome

Explore related trials

Aplastic AnemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tapan M Kadia · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Tapan Kadia, MD
[email protected]
713-563-3534
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

liver function (bilirubin \< 2mg/dL, AST \<3 x ULN)
kidney function (creatinine \< 2.5 x ULN ). 6. ECOG performance status of ≤ 2. 7. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 8. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 9. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol. 10. Patients should have an indication for therapy for their disease such as transfusion dependence or morbidity associated with their cytopenia(s) such as bleeding, severe fatigue, or frequent/multiple infections (eg. neutropenia).

What this trial measures

  • Achievement of responseUp to 6 years

    Measured by complete response (CR), partial response, or hematologic improvement.