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

Launched by M.D. ANDERSON CANCER CENTER · Jun 20, 2012

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a combination of medications to treat patients with aplastic anemia or a type of blood disorder called myelodysplastic syndrome. The medications being studied include methylprednisolone, horse anti-thymocyte globulin, cyclosporine, filgrastim, and pegfilgrastim. These treatments aim to improve low blood counts by targeting specific immune cells that may be causing the problem and promoting the growth of white blood cells, which help fight infections. The goal is to see if this combination can effectively help patients who are not candidates for a stem cell transplant.

To be eligible for the trial, participants must be at least 18 years old and have a diagnosis of either aplastic anemia or myelodysplastic syndrome. They should not have received certain treatments recently and must have good organ function. Participants will need to agree to use contraception during the study and will be closely monitored for their response to the treatments. This trial is currently recruiting patients, and those who qualify can expect regular check-ups to assess their condition and the effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with the diagnosis of MDS (Low, Int-1 by IPSS, or hypocellular) who are either previously treated or untreated are eligible for this trial.
• • 2. Patients with the diagnosis of aplastic anemia who are either previously treated or untreated are eligible if they are not currently candidates for an allogeneic stem cell transplant.
• • 3. Patients ages 18 years and older are eligible
• • 4. Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy for at least 2 weeks prior to entering this study, and have recovered from the toxic effects of that therapy to grade 1 or less.
• 5. Adequate organ function as defined below:
• • 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).
• Exclusion Criteria:
• • 1. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated on this study.
• • 2. Known HIV infection.
• • 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• • 4. Patient with documented hypersensitivity to any of the component medications.