← Back to Search

Antibody Drug Conjugate

Gemtuzumab Ozogamicin + Donor Leukocytes for Acute Myeloid Leukemia

Q: What potential harm could be experienced with the use of Gemtuzumab Ozogamicin (GO)?

Due to the lack of clinical evidence supporting its efficacy, our team at Power assigned Gemtuzumab Ozogamicin (GO) a safety score of 2.

Q: Is enrollment still open for this experiment?

According to the latest update on clinicaltrials.gov, this medical trial is still welcoming participants. It was initially posted at the turn of 2019 and has been modified as recently as April 27th 2022.

Q: Have any further investigations been done with respect to the efficacy of Gemtuzumab Ozogamicin (GO)?

Currently, 26 investigations are running that assess the efficacy of Gemtuzumab Ozogamicin (GO). Of those active studies, 3 have advanced to Phase 3. While Baltimore is the epicentre for this medication's research with a significant quantity of trials being conducted there; 582 other clinical sites are also conducting GO-related experiments.

Q: How large is the participant population for this research endeavor?

Affirmative. According to information provided on clinicaltrials.gov, this research endeavour was first advertised on December 31st 2019 and is currently attempting to recruit 18 test subjects from 1 medical facility.

Phase 2

Waitlist Available

Led By John Reagan, MD

Research Sponsored by John L. Reagan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 4-weeks since prior chemotherapy or radiation to cellular therapy infusion

Histologic confirmation of acute myeloid leukemia (AML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 2 years post end of treatment

Awards & highlights

Study Summary

This trial is testing whether the drug Gemtuzumab Ozogamicin, followed by an infusion of blood cells called leukocytes from a donor, can stimulate the immune system to potentially fight the leukemia.

Who is the study for?

Adults with relapsed acute myeloid leukemia (AML) who have no curative treatment options and have previously undergone standard treatments. They must be at least 18 years old, not pregnant or nursing, and agree to use two forms of contraception. Donors for leukocytes must be first or second-degree relatives, healthy, meet specific health criteria including being free from certain infections like HIV and hepatitis.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Gemtuzumab Ozogamicin (GO), an FDA-approved drug for AML that targets leukemia cells, followed by donor leukocyte infusions to stimulate the immune system against leukemia. Initially involving six patients to assess safety before expanding up to eighteen participants if no severe toxicities are observed.See study design

What are the potential side effects?

Potential side effects include reactions related to infusion such as fever or chills, low blood counts leading to increased infection risk or bleeding problems, liver issues like elevated enzymes or bilirubin levels which can indicate damage or disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It has been over 4 weeks since my last chemotherapy or radiation treatment.

Select...

I have been diagnosed with acute myeloid leukemia.

Select...

I do not have any ongoing infections.

Select...

My lung function is good and I don't have lung disease symptoms.

Select...

I can take care of myself but might not be able to do active work.

Select...

My kidney and liver functions are within the required limits.

Select...

My AML has returned or worsened within 6 months after treatment.

Select...

There are no treatments that can cure my condition.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post infusion for a total of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post infusion for a total of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and post infusion for a total of 2 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

Response Rate

Secondary outcome measures

Dose limiting toxicities

Survival

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2Experimental Treatment2 Interventions

Patients ≥70 years old: GO 6mg/m2 (2mg/m2 each dose) Patients: < 70 years old: GO 9mg/m2 (3mg/m2 each dose) Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^8 CD3+ cells and maximum of 2x10^8 CD3+ cells/kg irrespective of the number of CD34+ cells. Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.

Group II: Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1Experimental Treatment2 Interventions

Patients ≥70 years old: GO 6mg/m2 (2mg/m2 each dose) Patients < 70 years old: GO 9mg/m2 (3mg/m2 each dose) Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10^7 CD3+ cells and maximum of 2x10^7 CD3+ cells/kg irrespective of the number of CD34+ cells. Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Miriam HospitalOTHER

238 Previous Clinical Trials

37,464 Total Patients Enrolled

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,974 Total Patients Enrolled

John L. ReaganLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Gemtuzumab Ozogamicin (Antibody Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03374332 — Phase 2

Frequently Asked Questions

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

What potential harm could be experienced with the use of Gemtuzumab Ozogamicin (GO)?

"Due to the lack of clinical evidence supporting its efficacy, our team at Power assigned Gemtuzumab Ozogamicin (GO) a safety score of 2."

Answered by AI

Is enrollment still open for this experiment?

"According to the latest update on clinicaltrials.gov, this medical trial is still welcoming participants. It was initially posted at the turn of 2019 and has been modified as recently as April 27th 2022."

Answered by AI

Have any further investigations been done with respect to the efficacy of Gemtuzumab Ozogamicin (GO)?

"Currently, 26 investigations are running that assess the efficacy of Gemtuzumab Ozogamicin (GO). Of those active studies, 3 have advanced to Phase 3. While Baltimore is the epicentre for this medication's research with a significant quantity of trials being conducted there; 582 other clinical sites are also conducting GO-related experiments."

Answered by AI

How large is the participant population for this research endeavor?

"Affirmative. According to information provided on clinicaltrials.gov, this research endeavour was first advertised on December 31st 2019 and is currently attempting to recruit 18 test subjects from 1 medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia

John L. Reagan 2019. "Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03374332.

All > Acute Myeloid Leukemia > Aml