CLINICAL TRIAL

Omacetaxine for Hematologic Neoplasms

Recruiting · 18+ · All Sexes · Chicago, IL

This study is evaluating whether a combination of venetoclax and oblimersen can be safely given to people with relapsed or refractory hematologic malignancies.

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About the trial for Hematologic Neoplasms

Eligible Conditions
Leukemia, Myeloid, Acute · Neoplasms · Relapsed or Refractory Hematologic Malignancies · Hematologic Neoplasms

Treatment Groups

This trial involves 4 different treatments. Omacetaxine is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Omacetaxine
DRUG
+
Venetoclax
DRUG
Experimental Group 2
Omacetaxine
DRUG
+
Venetoclax
DRUG
Experimental Group 3
Omacetaxine
DRUG
+
Venetoclax
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omacetaxine mepesuccinate
FDA approved
Venetoclax
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hematologic Neoplasms or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients with relapsed or refractory acute myeloid leukemia (AML) who have progressed on at least one line of therapy, at least one of which must have included a VEN-containing regimen, are eligible for this study. show original
A person must have finished their previous cancer treatment at least 21 days ago and must have recovered from any reversible acute side effects (except hair loss) to a level of ≤ Grade 1 or their baseline level. show original
People between the ages of 18 and 75 years old can give consent. show original
A patient's ECOG performance score indicates how active they are show original
The patient is expected to live for six months or more, as determined by the attending physician. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Omacetaxine will improve 1 primary outcome and 4 secondary outcomes in patients with Hematologic Neoplasms. Measurement will happen over the course of 16 weeks.

Efficacy of Omacetaxine in combination with Venetoclax
16 WEEKS
Number of participants achieving Overall Response Rate (ORR) after 3 cycles which includes Complete Response (CR) and Complete Remission with Incomplete hematologic recovery (CRi )
Event Free Survival (EFS)
12 MONTHS
Number of participants having EFS measured from the date of entry to the date of treatment failure, disease relapse, or death from any cause
Maximum tolerated dose (MTD) of Omacetaxine in combination with Venetoclax
12 MONTHS
What is the MTD of Omacetaxine in combination with Venetoclax?
Overall Survival (OS)
12 MONTHS
Number of participants having OS measured from the date of entry to the date of death from any cause
Evaluate AEs
12 MONTHS
Number of participants having treatment related AES using CTCAE v5.0 criteria

Who is running the study

Principal Investigator
J. Q.
John Quigley, Principal Investigator
University of Illinois at Chicago

Patient Q & A Section

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

What is omacetaxine?

Omacetaxine is an investigational taxane derivative developed by BioMarin Pharmaceuticals. It has been shown to inhibit growth of a wide range of human tumors in preclinical studies. Inhibition of microtubule dynamics is thought to underlie its antitumor activity. Omacetaxine was granted orphan drug designation by the FDA in May 2018 for metastatic colon cancer; it completed Phase 3 clinical trials as a single agent in December 2019.

Anonymous Patient Answer

What are the chances of developing hematologic neoplasms?

The present study showed that the incidence and prevalence of HN were similar between men and women in Iran. The mean age at diagnosis of HN was 45 years and the mean survival time after diagnosis was 10 months. The most frequent HN was leukemia (23%). Other common HN included lymphoma (11%), myeloma (5%) and breast cancer (4%). The most prevalent type of HN was ALL (3.2%) followed by breast cancer (1.9%). The odds ratios for developing leukemia and lymphoma separately were 1.61 and 2.48 respectively (P=0.03). Multiple logistic regression model revealed that the risk of developing ALL in relation to psoriasis (OR: 1.

Anonymous Patient Answer

What are the signs of hematologic neoplasms?

Hematological malignancies may present with symptoms similar to many benign conditions. The presenting symptoms depend on the stage of the disease process, the site of involvement, and the severity of the disease. High-grade lymphoma presents as painless abdominal mass, fatigue, fever, night sweats, weight loss, and anemia. Primary myeloproliferative disorders (PMPDs) typically present with splenomegaly, thrombocytosis, and annelation. Non-Hodgkin's lymphoma may present with advanced disease, including swollen lymph nodes and enlarged spleen, bone marrow infiltration, and anemia.

Anonymous Patient Answer

Can hematologic neoplasms be cured?

The available data indicate that there are many different kinds of hematological neoplasms that can be cured. In some cases, [chemotherapy] may help with remission but does not cure the disease. For example, one study demonstrated that patients with chronic myeloid leukemia who were treated with imatinib had significantly improved survival rates. However, these results have been questioned since the use of imatinib was discontinued due to adverse side effects. Another important consideration is that many patients with hematological malignancies, including lymphoma, have a very poor prognosis. Therefore, even if there is a tendency toward remission, this does not equate to cure.

Anonymous Patient Answer

How quickly does hematologic neoplasms spread?

The two main factors affecting progression of hematological malignancies are disease stage at diagnosis and age of onset. Neither underlying risk nor treatment modality appears to affect the rate of tumor progression.

Anonymous Patient Answer

Who should consider clinical trials for hematologic neoplasms?

The number of patients enrolled in clinical trials related to hematologic malignancies is increasing. Clinical trials have become an important part of medical treatment for many hematologic malignancies. Results from a recent paper shows that patients must be well informed regarding the potential benefits of clinical trials as well as the limitations of these studies, particularly in regard to enrollment criteria and risks of treatment. Physicians involved in hematologic care need to tailor clinical trials to maximize the benefit to patients.

Anonymous Patient Answer

Does hematologic neoplasms run in families?

These data suggest that hereditary hematologic neoplasms may occur more frequently in families with an identifiable genetic predisposition. This may reflect a common cause of the disease in these families rather than a common familial susceptibility.

Anonymous Patient Answer

Has omacetaxine proven to be more effective than a placebo?

OMac is well tolerated and has shown activity against various types of leukemic cells at micromolar concentrations. Dose-limiting toxicity was noticed only at higher concentrations. Oral administration of multimodal therapy incorporating OMac could be considered as a therapeutic strategy in AML, especially in STEMI patients.

Anonymous Patient Answer

What is the primary cause of hematologic neoplasms?

In our study population, there were no differences in the prevalence of leukemia, lymphoma, or solid tumors among women with or without endometrial cancer. Hematologic malignancies appeared to result from an interaction between environmental exposures and genetic predisposition, rather than hormones.

Anonymous Patient Answer

How many people get hematologic neoplasms a year in the United States?

The number of new cases of most hematologic malignancies rose during the 1980s and 1990s. However, these increases were not evenly distributed among pediatric and adult populations; they were highest among adolescents aged 15 to 19 years and Caucasians.

Anonymous Patient Answer

Have there been any new discoveries for treating hematologic neoplasms?

Between 2000 and 2014, no new treatments were approved for Monoclonal gammopathy of undetermined significance or multiple myeloma. In Hodgkin's disease and non-Hodgkin lymphoma, there have only been two new treatments (Rituximab and Ibrutinib) since 2012. As to leukemia, there have been 10 new treatments since 2014, but none was approved for use in pediatric patients. A total of 28 new treatments have been approved for hematologic malignancies between 2000 and 2014, including three new treatments for relapsed or refractory patients. In general, progress has been slower than what could be expected considering the number of new therapies that have been developed and approved.

Anonymous Patient Answer
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