VOR33 for Leukemia, Myeloid, Acute

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine Siteman Cancer Center, Saint Louis, MO
Leukemia, Myeloid, Acute+2 More
VOR33 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called VOR33 may help treat acute myeloid leukemia.

See full description

Eligible Conditions

  • Leukemia, Myeloid, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myeloid, Acute

Study Objectives

This trial is evaluating whether VOR33 will improve 1 primary outcome and 10 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of Up to approximately 28 days.

Month 24
Incidence of toxicities to determine the MTD and RP2D of Mylotarg™
Month 24
Incidence of transplant-related mortality (TRM) post HCT
Day 28
Incidence of neutrophil engraftment
Month 12
Percentage of CD33-negative myeloid cells
Months 12 and 24
Overall Survival (OS)
Relapse-free Survival (RFS)
Up to 24 months
Incidence of acute GVHD Grade (G) G2-G4 and G3-G4
Incidence of chronic GVHD (all and moderate-severe)
Incidence of primary and secondary graft failure
Day 28
Time to neutrophil engraftment
Day 60
Time to platelet recovery

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Myeloid, Acute

Trial Design

3 Treatment Groups

Cohort 2
1 of 3
Cohort 1
1 of 3
Cohort 3
1 of 3
Experimental Treatment

This trial requires 18 total participants across 3 different treatment groups

This trial involves 3 different treatments. VOR33 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 2VOR33 infusion followed by Mylotarg Dose Level 2
Cohort 1VOR33 infusion followed by Mylotarg Dose Level 1
Cohort 3VOR33 infusion followed by Mylotarg Dose Level 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab ozogamicin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: months 12 and 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly months 12 and 24 for reporting.

Closest Location

Washington University School of Medicine Siteman Cancer Center - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Myeloid, Acute or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
AML sample from the patient must have evidence of CD33 expression (>0%)
Renal: estimated glomerular filtration rate (GFR) >60 mL/min
Must have a related or unrelated stem cell donor that is a 10/10 match for HLA-A, -B, -C, -DRB1 and -DQB1.
Cardiac: left ventricular ejection fraction (LVEF) ≥50%
Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) ≥66%.
Must be ≥18 and ≤70 years of age.
Must have confirmed diagnosis of AML in first or second complete remission (CR1 or CR2) or have bone marrow blasts ≤10% without circulating blasts.
AML must have intermediate or high-risk disease-related genetics and the presence of minimal residual disease (MRD). Subjects in CR2 or with persistent morphologic blasts; may have favorable disease-related genetics.
Candidate for HLA-matched allogeneic HCT using a myeloablative conditioning regimen.
Performance Status: Karnofsky score of ≥70.

Patient Q&A Section

What causes leukemia, myeloid, acute?

"The cause of acute leukemia, myeloid, is mostly unknown. But, the likelihood of leukemia, myeloid, acute progressing into chronic leukemia is affected by several factors, including patient age, sex and race, exposure to ionizing radiation and other exogenous substances (drugs or infection), and the particular type of leukemia. The risk is greater for acute lymphocytic leukemia compared to acute myelogenous leukemia. Exposure to ionizing radiation for cancer treatment and leukemia survivors have increased the risk of developing leukemia, myeloid, acute. This is due to the risk of developing leukemia as a result of mutation of genes responsible for DNA repair and the cellular pathways to repair DNA." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, myeloid, acute?

"Symptoms of leukemia, myeloid, acute will range from vague discomfort to life-threatening. Symptoms may arise in any of the body systems. Symptoms are quite variable and can resemble that of flu, cold or any other infection. The causes of symptoms are diverse and include the bone marrow and blood. Diagnosis is best accomplished through an evaluation by a physician. It is important to recognize the typical symptomatology of leukemia, myeloid, acute." - Anonymous Online Contributor

Unverified Answer

Can leukemia, myeloid, acute be cured?

"Chronic phase chronic myeloid leukemia and chronic phase acute myeloid leukemia are relatively curable when the karyotypic abnormality remains in < 15% of the nuclei, thus do not have the potential to be cured if the leukemia was refractory for a prolonged period of time." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, myeloid, acute a year in the United States?

"This national count is consistent with an estimated 2,600 new cases of leukemia, myeloid, acute in the next 5 years (2,620 in the last 5 yr). In addition to other cancer rates, an accurate 5-year count of the leukemias (acute lymphoblastic, acute myeloid, chronic lymphocytic, and multiple myeloma), and all myeloproliferative lymphoproliferative disorders (Chronic myelogenous, idiopathic, and primary myelofibrosis) should be kept." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, myeloid, acute?

"Treatment for leukemia, myeloid, acute is mostly chemotherapy or surgery. This article also discusses the treatment of children with leukemia with chemotherapy using growth hormone for growth problems, and with bone marrow transplants if the underlying leukemia is myelogenous. Although chemotherapy destroys the bone marrow, bone marrow transplantation can help the patient. Treatment with astemizole to reduce side effects from chemotherapy is also common." - Anonymous Online Contributor

Unverified Answer

What is leukemia, myeloid, acute?

"There are 20 identifiable variants, but most types can be diagnosed using clinical information and routine laboratory testing. The variants identified here comprise most cases of all-trans-retinoic acid (ATRA)-resistant acute myeloid leukemia and are potentially treatable with fludarabine, an analog of ATRA. We will not propose for these to be recognized as a separate "type." There are, however, many other variants, and some of these also could be treated in this way but this would have to be validated in studies in larger patient populations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of vor33?

"Vor33 is toxic in mice. The major side effects of vor33 in mice are lethality and renal cytopenia. The major side effects of vor33 in monkeys are reversible, dose-dependent renal toxicity and hepatic toxicity." - Anonymous Online Contributor

Unverified Answer

What does vor33 usually treat?

"There is less discussion about the overall efficacy of the vor33 gene therapy for the treatment of non-LMSC cancers than for LMSC malignancies. Clinicians will likely find clinical trials for specific cancers in the upcoming years." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia, myeloid, acute?

"It is common to hear people say 'there needs to be a breakthrough in cancer research to treat leukemia, myeloid, acute' and that such research doesn't happen very often. On that note, we discuss some significant recent discoveries relevant to hematological malignancies. As for the other types of malignancies we are discussing in this article, we don't intend to focus on such discoveries; rather, we expect that such discoveries will be mentioned and explained when relevant. In the future we expect other discoveries relevant to hematological malignancies, of which there many." - Anonymous Online Contributor

Unverified Answer

Is vor33 typically used in combination with any other treatments?

"Patients with acute leukemias (AL) and MDS and some patients with CLL who had vor33 used in combination with other treatments were responsive. The treatment schedules for patients used more than one treatment or used vor33 in combination with vor33 are currently being evaluated." - Anonymous Online Contributor

Unverified Answer

How does vor33 work?

"Data from a recent study suggest that the transcriptional profile of myeloid and lymphoid progenitor cells is differentially regulated by Vor33 and that Vor33 may target certain aspects of human myeloid and lymphoid development by altering the transcriptional activity of its targets; Vor33 may thus exert its proliferative effects on myeloid and lymphoid cells in ways that would not be anticipated in the absence of its target, which is not a member of the Vor family." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, myeloid, acute?

"While there is currently no cure available for leukemia, [power], a health information website for [people with leukemia, myeloid, acute (LMWE)] can help you find recent clinical trial information on treatments for these conditions. Clinical trials are often used to test whether a treatments or drug helps improve outcomes for those with LMWE, even if they do not cure the condition. While LMWE treatments exist, [research] can help you choose the treatment that will best meet your individual needs." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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