Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia
NCT ID: NCT04526795
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
19 participants
INTERVENTIONAL
2021-04-09
2024-11-15
Brief Summary
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Detailed Description
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I. To determine the safety and tolerability of fludarabine, cytarabine (araC), and pegcrisantaspase in patients with relapsed and refractory leukemias.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (complete remission \[CR\], CR with incomplete count recovery \[CRi\], partial remission \[PR\], or morphologic leukemia free state \[MLFS\]) of a lead-in dose of single-agent pegcrisantaspase in patients with relapsed and refractory leukemias.
II. To determine the overall response rate (complete remission \[CR\], CR with incomplete count recovery \[CRi\], partial remission \[PR\], or morphologic leukemia free state \[MLFS\]) of fludarabine, araC, and pegcrisantaspase in patients with relapsed and refractory leukemias.
III. To assess overall survival (OS) and disease-free survival (DFS) of patients treated with fludarabine, araC, and pegcrisantaspase.
IV. To assess the duration of response to the combination in patients with advanced leukemias.
V. To characterize the pharmacokinetics (PK) pharmacodynamics (PD) anti-drug antibodies (ADA) of pegcrisantaspase in patients with relapsed and refractory leukemias.
EXPLORATORY OBJECTIVE:
I. Explore pretreatment and on-treatment biological correlates to predict sensitivity/resistance of pegcrisantaspase-based therapy.
OUTLINE: This is a dose-escalation study of pegcrisantaspase.
INDUCTION: Patients receive pegcrisantaspase intravenously (IV) over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-11 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-10. Treatment repeats every 5 weeks for up 3 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (pegcrisantaspase, fludarabine, cytarabine)
INDUCTION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-11 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive pegcrisantaspase IV over 60 minutes on days 1 and 15, and fludarabine IV over 15-30 minutes and cytarabine IV over 2 hours on days 8-10. Treatment repeats every 5 weeks for up 3 cycles in the absence of disease progression or unacceptable toxicity.
Cytarabine
Given IV
Fludarabine
Given IV
Pegcrisantaspase
Given IV
Interventions
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Cytarabine
Given IV
Fludarabine
Given IV
Pegcrisantaspase
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Tapan M Kadia
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-05459
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0434
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0434
Identifier Type: -
Identifier Source: org_study_id