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TERMINATEDPHASE2

Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.

A Phase II Trial of Fludarabine in Combination With Daunorubicin and Cytarabine Liposome for Adults With Newly-diagnosed Acute Myeloid Leukemia: University of California Hematologic Malignancies Consortium Protocol 1914

NCT04425655•University of California, San Diego

View on ClinicalTrials.gov

Summary

This phase 2 clinical trial will evaluate the effectiveness and safety of fludarabine in combination with CPX-351 in patients with untreated AML. Patients will receive fludarabine and CPX-351 during Induction 1 and 2 as well as 2 cycles of consolidation therapy.

Detailed Description

This is a phase 2, open label single arm study to look at the effectives and safety of fludarabine in combination with CPX-351 in patients with untreated AML. The rationale for this combination stems from data which indicated that pre-treatment of the THP-1 cell line with fludarabine for 4 hours prior to CPX-351 administration (Flu-CPX) significantly potentiated intracellular ara-CTP accumulation compared to CPX-351 alone. This suggests that fludarabine combined with CPX-351 may have efficacy against leukemic clones that would be resistant to CPX-351 or standard chemotherapy in first induction. It has been demonstrated that treatment with CPX-351 produces superior clinical outcomes in secondary AML likely due to its novel formulation, which results in sustained exposure of the cytotoxic agents cytarabine and daunorubicin in a synergistic 5:1 ratio within the plasma and bone marrow. Fludarabine can potentially improve upon the outcomes observed with CPX-351 monotherapy and 7+3 by enhancing intracellular ara-CTP accumulation from CPX-351. Patients will received fludarabine and CPX-351 for up to 2 cycles of induction and 2 cycles of consolidation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed de novo or secondary AML as defined by WHO criteria
•2. Intermediate- or poor-risk disease by ELN 2017 criteria
•3. Adults 18 years of age or older
•4. ECOG performance status of 0, 1, or 2
•5. Able to give informed consent and follow study guidelines
•6. Organ function requirements:
•1. Adequate renal function defined as creatinine clearance greater than 60 ml/min
•2. Adequate hepatic function defined by serum bilirubin less than or equal 2 mg/dL. If serum bilirubin greater than 2 mg/dl and direct bilirubin is less than 30 percent of total bilirubin contact study chair for eligibility exception for Gilbert's syndrome.
•3. ALT/AST less than or equal to 3 times the upper limit of normal
•4. LVEF 50 percent by echocardiogram or MUGA
+2 more criteria

Exclusion Criteria

•1. Current or anticipated use of additional investigational agents.
•2. Any prior treatment for AML with the exception of corticosteroids, hydroxyurea, and/or leukapheresis to prevent or treat early complications prior to starting study therapy. Permitted prior therapy must be stopped 24 hours prior to starting study therapy.
•3. Prior use of hypomethylating agents is permitted for patients with history of antecedent MDS. Last dose of hypomethylating therapy must have been 15 or more days prior to starting study therapy. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment.
•4. Favorable risk cytogenetics as defined by 2017 ELN risk stratification including acute promyelocytic leukemia
•5. Chronic myeloid leukemia in myeloid blast crisis
•7. Clinical evidence of active CNS leukemia
•8. Active or metastatic second malignancy
•9. Any major surgery or radiation therapy within four weeks.
•10. Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
•11. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
+9 more criteria

Locations (1)

UCSD Moores Cancer Center

La Jolla, California, United States

Key Dates

Start Date

August 5, 2020

Primary Completion Date

July 1, 2022

Completion Date

July 1, 2022

Last Updated

September 22, 2022

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia, AdultAMLAML, Adult

Interventions

Fludarabine

DRUG

Vyxeos

DRUG

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AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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RECRUITINGPHASE1

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

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High-risk Myelodysplastic SyndromeChronic Myelomonocytic Leukemia (CMML)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

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