Gemtuzumab Ozogamicin + Donor Leukocytes for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byJohn Reagan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: John L. Reagan

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying 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. Gemtuzmab ozogamicin is a class of drugs known as an antibody drug conjugate. The drug is given on days 1,4,7. It is infused, attaches to cells with a certain marker on the surface (the majority of which would be leukemia cells). The drug is then internalized and the chemotherapy drug becomes activated. Gemtuzumab is currently FDA approved for the treatment of acute myeloid leukemia. The infusion of leukocytes to stimulate the immune system to fight your leukemia is investigational and has not been proven to cure cancer. This combination of Gemtuzumab Ozogamicin and donor leukocytes is not an FDA approved treatment and is investigational. Initially a total of 6 patients will be included in the study to assess the safety of the treatment. Once 6 patients have been treated and no unacceptable toxicities are seen, more patients will be enrolled. The study will treat up to 18 patients on the study.

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with acute myeloid leukemia.

Women of childbearing potential and sexually active males must use 2 forms of effective contraception method from time of consent through 6 months after completing treatment (whether last treatment is infusion or drug)

+12 more

Exclusion Criteria

Evidence of HIV infection

I have had a stem cell transplant from a donor.

I haven't had purine analog or alemtuzumab treatments in the last year.

+9 more

Participant Groups

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.

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.

Gemtuzumab Ozogamicin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Mylotarg for: