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Antibody Drug Conjugate

Gemtuzumab Ozogamicin + Donor Leukocytes for Acute Myeloid Leukemia

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)

Must not have

Previous allogeneic stem cell transplant

Previous history of Veno-occlusive disease/Sinusoidal Obstruction Syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 2 years post end of treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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I have been diagnosed with acute myeloid leukemia.

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I do not have any ongoing infections.

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

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

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My kidney and liver functions are within the required limits.

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

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There are no treatments that can cure my condition.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant from a donor.

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I have had Veno-occlusive disease/Sinusoidal Obstruction Syndrome before.

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I have active hepatitis B or C.

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I have been treated with Gemtuzumab ozogamicin before.

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I am eligible for a stem cell transplant from a donor.

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I have active leukemia in my brain or spinal cord.

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I need oxygen therapy for my lung condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate

Secondary study objectives

Dose limiting toxicities

Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met