Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia (NCT04526795) | Clinical Trial Compass
TerminatedPhase 1
Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia
Stopped: Administratively Complete
United States19 participantsStarted 2021-04-09
Plain-language summary
This phase Ib trial investigates the side effects and best dose of pegcrisantaspase when given together with fludarabine and cytarabine for the treatment of patients with leukemia that has come back (relapsed) or has not responded to treatment (refractory). Pegcrisantaspase may block the growth of cancer cells. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pegcrisantaspase in combination with fludarabine and cytarabine may work better in treating patients with leukemia compared to the combination of fludarabine and cytarabine.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of relapsed or refractory leukemia including, but not limited to acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), T-cell prolymphocytic leukemia, biphenotypic acute leukemia, or blast-phase of chronic myeloid Leukemia (CML) will be allowed during the safety lead-in phase
* For cohort A of the expansion phase: Patients with a diagnosis untreated adverse-risk AML (as defined by ELN \[European Leukemia Net Classification\] 2017) will be enrolled
* For cohort B of the expansion phase: Patients with a diagnosis of relapsed or refractory AML will be enrolled
* Bilirubin =\< 2 mg/dL
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* Creatinine =\< 1.5 x ULN
* Cardiac ejection fraction of \> or = 45% within the past 3 months
* Amylase and lipase =\< 1.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* A negative urine pregnancy test is required within one week (7 days) for all women of childbearing potential prior to being registered on this trial
* 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
Exclusion Criteria:
* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or ab…