CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 140 target
Drug / intervention
Anti-Thymocyte Globulin +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01624805
NCT01624805Phase 2RecruitingOn Track
Long Recruiting
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Phase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Jun 21, 2012·Updated Jun 22, 2026

In Brief

A Phase 2 clinical trial evaluating Anti-Thymocyte Globulin, Cyclosporine, and 3 other interventions for Aplastic Anemia and 3 related conditions. Currently recruiting, targeting 140 participants across 1 site.

Detailed Summary

This phase II trial studies 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. Horse anti-thymocyte globulin is made from horse blood and targets immune cells known as T-lymphocytes. Since T-lymphocytes are believed to be involved in causing low blood counts in aplastic anemia and in some cases of myelodysplastic syndromes, killing these cells may help treat the disease. Methylprednisolone and cyclosporine work to suppress immune cells called lymphocytes. This may help to improve low blood counts in aplastic anemia and myelodysplastic syndromes. Filgrastim and pegfilgrastim are designed to cause white blood cells to grow. This may help to fight infections and help improve the white blood cell count. Giving methylprednisolone and horse anti-thymocyte globulin together with cyclosporine, filgrastim, and/or pegfilgrastim may be an effective treatment for patients with aplastic anemia or myelodysplastic syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAplastic Anemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
201220132014201520162017201820192020202120222023202420252026202720282029
First PostedJun 21, 2012
Enrollment StartJun 25, 2012
Primary CompletionJun 30, 2029
TodayJul 1, 2026
Enrollment to primary: 17.0 yearsPosted 14.0 years agoPrimary completion in 3.0 years

Arms & Interventions

Treatment (methylprednisolone, hATG, cyclosporine, G-CSF)experimental

Patients receive methylprednisolone IV over 10 minutes on days 1-4 and IV or PO with taper over days 5-30. Patients also receive horse anti-thymocyte globulin IV over 8 hours daily on days 1-4, cyclosporine PO BID on days 1-180, and pegfilgrastim or pegfilgrastim biosimilar SC on day 5 and/or filgrastim SC beginning on day 5 and continuing until absolute neutrophil count recovers. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

Biological: Anti-Thymocyte GlobulinDrug: CyclosporineBiological: FilgrastimDrug: MethylprednisoloneBiological: Pegfilgrastim

Interventions

Anti-Thymocyte Globulinbiological

Given IV

Cyclosporinedrug

Given PO

Filgrastimbiological

Given SC

Methylprednisolonedrug

Given IV or PO

Pegfilgrastimbiological

Given SC