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Topoisomerase II inhibitors

mitoxantrone + etoposide + gemtuzumab ozogamicin for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Konstantinos Lontos, MD
Research Sponsored by Robert Redner, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights

Study Summary

This trial is testing a new combination therapy for leukemia patients who didn't respond to initial treatment.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Remission Rate
Secondary outcome measures
Cytogenetic Status
Overall Survival (OS)
Percent of blasts
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: mitoxantrone + etoposide + gemtuzumab ozogamicinExperimental Treatment1 Intervention
10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mitoxantrone + etoposide + gemtuzumab ozogamicin
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,857 Total Patients Enrolled
Robert Redner, MDLead Sponsor
1 Previous Clinical Trials
29 Total Patients Enrolled
Konstantinos LontosLead Sponsor

Frequently Asked Questions

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

Are there any spots remaining for this experiment?

"Clinicaltrials.gov cites that this investigation is actively recruiting individuals to join its trial, which was first announced on February 28th 2019 and edited most recently on February 9th 2022."

Answered by AI

What health risks are associated with mitoxantrone + etoposide + gemtuzumab ozogamicin?

"The safety of the combination treatment mitoxantrone + etoposide + gemtuzumab ozogamicin has been assessed as a 2, based on Phase 2 trial data that suggest some degree of safety but do not indicate efficacy."

Answered by AI

What type of individuals can volunteer for this medical experiment?

"This trial is open to 53 applicants aged 18-75 with acute myeloid leukemia or myelodysplastic syndrome that persists after treatment. Eligible patients must be able to comprehend and grant written consent, have an Eastern Cooperative Oncology Group Performance Status of 0-2, a creatinine clearance of at least 30 mL/min, AST and ALT levels no higher than two times the upper normal limit, total bilirubin not exceeding twice the upper normal limit, and CD33 expression detected in over thirty percent of leukemic blasts on the bone marrow sample. Pancytopenia resulting from disease progression"

Answered by AI

What other data has been collected concerning the combined effects of mitoxantrone, etoposide and gemtuzumab ozogamicin?

"Currently, 366 clinical trials are being conducted on the combination of mitoxantrone + etoposide + gemtuzumab ozogamicin. Out of these studies, 100 have developed to Phase 3 tests. The majority of such experiments take place in New york City; however there exists an additional 16368 sites across the globe running corresponding investigations."

Answered by AI

Are individuals younger than 60 being included in this clinical experiment?

"This clinical trial is open to any patient aged between 18 and 75 years old. Furthermore, there are 597 trials for those under the legal age of consent and 1470 for individuals over 65."

Answered by AI

What ailments is the combination of mitoxantrone, etoposide and gemtuzumab ozogamicin most frequently utilized to treat?

"Mitoxantrone + etoposide + gemtuzumab ozogamicin is a commonly employed therapeutic regimen for treating small cell lung cancer and also has applications in the treatment of lymphoma, Hodgkin's disease, metastatic thymic cancer, acute myelocytic leukemia."

Answered by AI

How many people are currently taking part in this experiment?

"Yes, the clinicaltrials.gov database indicates that this study is in search of participants at present. The first posting was on February 28th 2019 and it has been modified as recently as February 9th 2022; 53 individuals are needed from one particular site to complete the trial."

Answered by AI
~3 spots leftby Apr 2025