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Anti-tumor antibiotic

Daunorubicin for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Chandni Dargan, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a lower dose of the chemotherapy drug daunorubicin given over 5 days, to see if it's less toxic than the standard dose given over 3 days.

Eligible Conditions
  • Refractory Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Absolute Blast Count
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Extramedullary Leukemia Progression
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Patient Symptoms
+2 more
Secondary outcome measures
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Area Under the Curve.
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Elimination Half-life
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Maximum Concentration.
+1 more

Side effects data

From 2019 Phase 3 trial • 657 Patients • NCT00049517
98%
Leukopenia
98%
Thrombocytopenia
97%
Anemia
97%
Neutropenia
61%
Transfusion platelets
60%
Transfusion: PRBCS
47%
Infection w/ Gr3-4 neutropenia
37%
Febrile neutropenia
9%
Hemorrhage with Grade 3 or 4 Platelets
8%
Anorexia
7%
Fever
6%
Nausea
5%
Dyspnea
5%
Fatigue
5%
Rash
4%
Hypoxia
4%
Bilirubin Increased
3%
ALT Increased
3%
Stomatitis
3%
Hypotension
3%
Infection w/o neutropenia
3%
Hypokalemia
2%
Diarrhea w/o prior colostomy
2%
Epistaxis
2%
Hypoalbuminemia
2%
Pain-other
2%
hyperglycemia
2%
Colitis
2%
Syncope
2%
Typhlitis
2%
Hypertension
2%
DIC
2%
Vomiting
2%
Petechiae
2%
Hyponatremia
2%
Pneumonitis/pulmonary infiltrates
1%
Dysphagia
1%
AST increased
1%
Abdominal Pain
1%
Confusion
1%
Pericardial Effusion/Pericarditis
1%
Wound-infectious
1%
Diarrhea
1%
ARDS
1%
Thrombosis
1%
CNS hemorrhage
1%
Ocular-Other
1%
Arthralgia
1%
Renal Failure
1%
Tumor Lysis Syndrome
1%
Pruritus
1%
Bone, pain
1%
Proctitis
1%
Lymphopenia
1%
Hemoptysis
1%
Vaginal Bleeding
1%
Hypocalcemia
1%
Hypophosphatemia
1%
Dizziness/Lightheadedness
1%
Hallucinations
1%
Anxiety/Agitation
1%
Headache
1%
Rectal or Perirectal Pain
1%
Pleural effusion
1%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Daunorubicin (Induction Therapy)
High Dose Daunorubicin (Induction Therapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with relapsed/refractory ALL and AMLExperimental Treatment1 Intervention
Patients in this arm will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
2013
Completed Phase 4
~4940

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,785 Total Patients Enrolled
Chandni Dargan, MDPrincipal Investigator - Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this trial still open to volunteers?

"Affirmative - clinicaltrials.gov reveals that this medical trial is actively enrolling participants. The study was initiated on May 8th 2020 and the most recent update occurred July 1st 2022; it seeks to enrol 10 patients from one site."

Answered by AI

What is the intended outcome of this research endeavor?

"The primary aim of this two-year trial is to evaluate the pro/anti-cancer cellular immune response in patients with relapsed or refractory acute leukemia upon targeted anthracycline treatment. Secondary objectives include exploring pharmacokinetic parameters such as time at maximum concentration, maximum concentration, and elimination half-life through serial daunorubicin level evaluations taken before infusion and at multiple intervals post administration."

Answered by AI

Has Daunorubicin been investigated in other research studies?

"Presently, 104 studies are being conducted on Daunorubicin with 35 reaching the third phase. Houston is a major city for research related to this drug; however, 7437 medical centres across the United States of America are currently running trials."

Answered by AI

What medical conditions can Daunorubicin be employed to alleviate?

"Primarily prescribed for lymphoma, daunorubicin can additionally be used to alleviate the symptoms of Ewing's tumor, newly diagnosed therapy-related acute myeloid leukemia, and ALL (acute lymphoblastic leukemia)."

Answered by AI

Has the FDA sanctioned Daunorubicin for clinical usage?

"Although there is some evidence to suggest that Daunorubicin is safe, as this study has only reached Phase 2 trials and without any data backing efficacy yet, its safety rating was determined to be a score of 2."

Answered by AI

Is this medical study open to applicants aged eighty-five and above?

"As indicated by the eligibility requirements, individuals must be between 1 year old and 21 years of age to partake in this clinical trial."

Answered by AI

How many participants have been enrolled in this clinical trial thus far?

"Affirmative. The particulars posted on clinicaltrials.gov verify that this medical study, initially published on 8th May 2020, is actively accepting volunteers. 10 test subjects are necessary to be enrolled from a single institution."

Answered by AI

Do I meet the criteria to join in this research endeavor?

"This particular trial is accommodating a maximum of 10 patients suffering from acute leukemia, aged between 1 and 21 years old. To be eligible for participation they must have received two prior therapeutic attempts that were ineffective or been in relapse more than once but unable to receive intensive care at the time of consent. Upfront therapies are allowed as well as pulse steroids lasting 5 days or less given during routine maintenance therapy."

Answered by AI
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~0 spots leftby Apr 2025