Acute Myeloid Leukemia Clinical Trial
Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia
Summary
This protocol is an open label, single arm, non-randomized, phase I / II clinical trial investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of allogeneic hematopoietic stem cell transplantation (HCT).
Full Description
This protocol is an open label, single arm, non-randomized, phase I / II clinical trial investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of allogeneic hematopoietic stem cell transplantation (HCT). The inability to attain remission status following induction therapy for AML remains a significant problem and is associated with poor outcomes. While HCT remains a curative option, its activity in the setting of relapsed or refractory AML is significantly diminished due to high relapse.
Eligibility Criteria
Inclusion Criteria:
Patient must have AML not in remission or at very high risk for HCT (Hematopoietic Cell Transplantation) relapse.
For newly diagnosed AML, patients must have achieved two consecutive induction attempts without achieving complete remission
For patients initially in complete remission whose AML relapses > 6 months after preceding remission, one re-induction must be attempted to be eligible
For AML patients with early relapse, in whom the preceding remission is shorter than 6 months duration, no re-induction regimen is necessary to be eligible
Patients with antecedent MDS (Myelodysplastic Syndrome) who progress to AML may have therapies rendered during both phases counted towards these requirements.
Patients with poor cytogenetic or molecular risk associated with very high risk for relapse after HCT may proceed without provisions for prior treatment. However, they must have received at least one induction attempt.
Patients must be ≥ 18 years of age and considered a candidate for HCT
Karnofsky ≥ 70% (Karnofsky performance status is measure of a cancer patients general well being and activities of daily life. Scores range from 100 to 0 where 100 is perfect health and 0 is death
Patients must meet acceptable organ function criteria: Total Bilirubin ≤2.5 mg%; AST (Aspartate transaminase) and ALT (Alanine transaminase) <5.0 X institutional upper limit of normal; GFR (Glomerular filtration rate) >40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; Lung function tests (DLCO, FEV1, FVC) > 50%; Ejection fraction > 50%
All patients must sign an informed consent
Women and men of child-bearing potential must agree to use adequate contraception
Exclusion Criteria:
Prior chemotherapy treatment for AML within 21 days from the initiation of HCT conditioning
Patients may NOT have evidence or symptoms of CNS disease at the time of enrollment
HIV or HTLV1 / HTLV2 (Human T-lymphotrophic virus) (seropositivity and/or PCR positivity)
Patients less than 18 years of age
Pregnant and nursing mothers are excluded from this study
Patients with untreated or uncontrolled neuropsychiatric illness
Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
Uncontrolled infections
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There is 1 Location for this study
Ann Arbor Michigan, 48109, United States
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