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

NCT04425655 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia, Adult
  • AML
  • AML, Adult

Interventions

DRUG

Fludarabine

30mg/m2 days 1 through 5

DRUG

Vyxeos

100U/m2 days 1, 3 5 in induction, 65U/m2 days 1 and 3 for consolidation

Sponsors & Collaborators

Principal Investigators

  • Matthew Wieduwilt, MD, PhD · UC San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2022-07-01
Completion
2022-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425655 on ClinicalTrials.gov