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Purine Analogues

Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Roland Walter

Research Sponsored by Fred Hutchinson Cancer Research Center

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 5 years. 2-year rfs reported.

Awards & highlights

Study Summary

This trial is studying how well gemtuzumab ozogamicin works when given with other cancer treatments in treating patients with acute myeloid leukemia or high-grade myeloid tumors that have not been previously treated.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years. 2-year rfs reported.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years. 2-year rfs reported.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years. 2-year rfs reported. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival (EFS) Rate (Phase 2)

Gemtuzumab ozogamicin

Secondary outcome measures

30-day All-cause Mortality

Neoplasm, Residual

+5 more

Side effects data

From 2021 Phase 4 trial • 51 Patients • NCT03727750

22%

Febrile Neutropenia

18%

Thrombocytopenia

18%

Hypokalaemia

16%

Nausea

14%

Sepsis

12%

Vomiting

12%

Pyrexia

10%

Constipation

10%

Diarrhoea

10%

Anaemia

10%

Neutropenia

10%

Aspartate Aminotransferase Increased

10%

Disease Progression

10%

Hypomagnesaemia

10%

Headache

10%

Epistaxis

Fatigue

Alanine Aminotransferase Increased

Asthenia

Abdominal Pain Upper

Gamma-Glutamyltransferase Increased

Infusion Related Reaction

Gingival Bleeding

Chills

Pneumonia

Acute Kidney Injury

Atypical Pneumonia

Dehydration

Traumatic Intracranial Haemorrhage

Atrial Fibrillation

Covid-19 Pneumonia

Escherichia Urinary Tract Infection

Fall

Capillary Leak Syndrome

Supraventricular Tachycardia

Eye Infection Fungal

Neutropenic Sepsis

Pneumonia Respiratory Syncytial Viral

Sinusitis

Acute Myeloid Leukaemia

Respiratory Failure

Vitreous Floaters

Gastric Haemorrhage

Multiple Organ Dysfunction Syndrome

Pneumonia Klebsiella

100%

80%

60%

40%

20%

Study treatment Arm

Gemtuzumab Ozogamicin (GO)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (GO, GCLAM)Experimental Treatment6 Interventions

INDUCTION THERAPY: Participants receive gemtuzumab ozogamicin IV either as a single dose on day 1, or as three doses on days 1, 4, and 7. Participants also receive G-CSF SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, and mitoxantrone hydrochloride IV on days 1-3. Patients who do not achieve a CR or CRi following the first cycle of induction are eligible for a second cycle, which is given without gemtuzumab ozogamicin. Participants with a CR or CRi may then proceed to Post-Remission Therapy. POST-REMISSION THERAPY: Participants receive G-CSF, cladribine, and cytarabine as in Induction Therapy during cycle 1, and cytarabine IV every 12 hours on days 1-6 of cycles 2-3. Treatment repeats every month for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Filgrastim

FDA approved

Cladribine

FDA approved

Mitoxantrone

FDA approved

Gemtuzumab ozogamicin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,179 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,202 Total Patients Enrolled

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,910,374 Total Patients Enrolled

Frequently Asked Questions

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

What aim is this experiment endeavoring to fulfill?

"This clinical trial aims to identify the Maximum Tolerable Dose (MTD) of Gemtuzumab Ozogamicin (GO) When Added to GCLAM over a one year period beginning with treatment initiation. Secondary objectives include evaluating Complete Response + Incomplete Hematologic Recovery Rate, Measurable Residual Disease Negative Status, Overall Survival and Aplasia Frequency. Regression models will be used for statistical comparison between patient outcomes who received or did not receive GO in addition to controlling for prognostic factors."

Answered by AI

What is the current enrollment capacity for this research trial?

"Unfortunately, this medical research is no longer accepting new participants. It was initially posted on September 14th 2018 and last updated October 10th 2022. If you are still looking to get involved in clinical trials for cancer, there are currently 3816 open studies that need volunteers; 394 of these involve Gemtuzumab Ozogamicin specifically."

Answered by AI

Could you please provide a synopsis of past experiments involving Gemtuzumab Ozogamicin?

"At present, 398 clinical studies are examining the therapeutic potential of Gemtuzumab Ozogamicin. Of those, 93 have advanced to Phase 3 trials and Saint Louis, Missouri continues to be a hub for such research with 12930 sites offering this medication."

Answered by AI

Has the recruitment process for this clinical trial begun?

"This experiment is no longer open for recruitment. Initially posted on September 14th 2018, the trial was last modified on October 10th 2022. For individuals who are curious about similar studies, there are currently 3816 clinical trials actively enrolling those with cancer and 398 studies recruiting patients to receive Gemtuzumab Ozogamicin treatments."

Answered by AI

For what maladies is Gemtuzumab Ozogamicin typically prescribed?

"Hemopoietic stem cell transplant is typically managed with Gemtuzumab Ozogamicin. This immunotherapy intervention has also been found to be effective in treating bone marrow transplants, diagnostic imaging, and combating infection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm

Roland B Walter 2018. "Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03531918.