What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy often leads to side effects such as neutropenia, anemia, thrombocytopenia, fatigue, and increased risk of infections. Targeted therapies, like gemtuzumab ozogamicin, can cause liver toxicity, infusion reactions, and myelosuppression. Immunotherapies, including cancer vaccines like Galinpepimut-S (GPS), may result in injection site reactions, flu-like symptoms, and potential immune-related adverse effects. These treatments aim to manage AML but come with a range of side effects that need to be carefully monitored.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Acute Myeloid Leukemia (AML). Oral azacitidine (CC-486) is approved for post-remission maintenance therapy in patients who have achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) following intensive induction chemotherapy. Gemtuzumab ozogamicin (GO) is another approved option for maintenance therapy, administered as a single agent. Additionally, IDH inhibitors are approved for continued treatment in patients showing a continued response. These treatments focus on maintaining remission and delaying relapse, similar to the approach of Galinpepimut-S (GPS), which targets the WT1 protein in AML patients in second or later complete remission.

What other types of research exist?

One promising alternative to Galinpepimut-S (GPS) for AML patients is Gemtuzumab ozogamicin (GO). GO is an immunoconjugate consisting of a CD33 antibody linked to calicheamicin, a potent cytotoxic agent. It has shown efficacy in treating relapsed and refractory AML in both adults and children. Another potential alternative is the combination of immune checkpoint inhibitors, such as durvalumab and tremelimumab, which have shown efficacy in other cancers and are being explored for AML treatment.

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Cancer Vaccine

Galinpepimut-S for Acute Myeloid Leukemia (REGAL Trial)

Phase 3

Waitlist Available

Research Sponsored by Sellas Life Sciences Group

Eligibility Criteria Checklist

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

Must have

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3

Must be in second morphological complete remission (with or without platelet recovery)

Must not have

Has had an allogeneic tissue/solid organ transplant

Currently have central nervous system leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6, 9, and 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a treatment called GPS, which helps the immune system fight cancer, in patients with AML who have experienced multiple remissions. The goal is to see if GPS can improve survival rates by making the body's natural defenses better at destroying cancer cells.

Who is the study for?

Adults over 18 with acute myeloid leukemia (AML) in second remission, not eligible for stem cell transplant, and who have good liver function. Women must be non-pregnant, postmenopausal or surgically sterile; sexually active participants must use contraception. Excludes those with severe allergies to certain immune stimulants, other cancers within 5 years, autoimmune diseases requiring treatment in the past 2 years, CNS leukemia or recent investigational drug use.

What is being tested?

The trial is testing Galinpepimut-S (GPS), a new therapy against the best available treatments chosen by investigators for AML patients in their second complete remission. The main goal is to compare overall survival rates between GPS and existing therapies.

What are the potential side effects?

Potential side effects of Galinpepimut-S may include allergic reactions due to its components like Montanide and immune stimulants GM-CSF or G-CSF. Other common cancer treatment side effects could occur such as fatigue, nausea, blood disorders but specific side effects of GPS are not detailed.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do heavy physical work.

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My cancer is in its second complete remission.

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I have been diagnosed with AML.

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I am 18 years or older and have given my consent.

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I am not eligible for a stem cell transplant from a donor.

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My kidneys are not in end stage failure.

Exclusion Criteria

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

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I have received a transplant from another person.

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My leukemia has spread to my brain or spinal cord.

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I have been treated for an autoimmune disease in the last 2 years.

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My cancer has spread to my brain or its coverings.

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I am currently being treated for a severe infection.

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I am continuing treatment that helped me achieve a second or later remission.

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I have an immune system disorder or am on long-term steroids.

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I have been diagnosed with a type of leukemia called acute promyelocytic.

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I have another cancer that has worsened or needed treatment in the last 5 years.

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I haven't had a stem cell transplant after achieving my second or later complete remission.

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I am scheduled for a stem cell transplant soon.

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I am currently on treatment for AML.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6, 9 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6, 9 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 9 and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival

Secondary study objectives

LFS

LFS rate (%)

MRD

+1 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Galinpepimut-S + Montanide + GM-CSFExperimental Treatment3 Interventions

A maximum of 15 total injections will be administered as follows: 1. First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase. 2. Injections 7 to 12: every 4 weeks (between Weeks 14 and 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (between Weeks 40 and 52). The third series of injections of galinpepimut-S define the late immune booster phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered one day before and on the same day as the galinpepimut-S + Montanide injection.

Group II: Best Available TherapyActive Control5 Interventions

Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Galinpepimut-S

2011

Completed Phase 2

~60

GM-CSF

2011

Completed Phase 4

~1280

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies, such as FLT3 inhibitors, block specific molecular pathways essential for cancer cell survival. Immunotherapies, including monoclonal antibodies and cancer vaccines like Galinpepimut-S (GPS), harness the body's immune system to recognize and destroy leukemia cells. GPS targets the WT1 protein, which is overexpressed in AML cells, aiming to stimulate an immune response specifically against these cancer cells. These treatments are crucial as they offer more precise and potentially less toxic options compared to traditional chemotherapy, improving outcomes and quality of life for AML patients.

Targeting the innate immune system as immunotherapy for acute myeloid leukemia.