Status:
TERMINATED
Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Acute Biphenotypic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 (...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability of fludarabine, cytarabine (araC), and pegcrisantaspase in patients with relapsed and refractory leukemias. SECONDARY OBJECTIVES: I. T...
Eligibility Criteria
Inclusion
- 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
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient with documented hypersensitivity to any of the components of the chemotherapy program
- Prior treatment with pegylated asparaginase
- Patients with a diagnoses of acute promyelocytic leukemia (AML-M3) will be excluded from this trial
- Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Effective methods of birth control include:
- Birth control pills, shots, implants or patches
- Intrauterine devices (IUDs)
- Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide
- Abstinence
- Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation, oophorectomy, and/or hysterectomy
- Patients with history of clinically significant venous thromboembolism
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04526795
Start Date
April 9 2021
End Date
November 15 2024
Last Update
December 12 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030