HM43239 for Leukemia, Myeloid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
Leukemia, Myeloid+3 More
HM43239 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

See full description

Eligible Conditions

  • Leukemia, Myeloid
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myeloid

Study Objectives

This trial is evaluating whether HM43239 will improve 5 primary outcomes and 5 secondary outcomes in patients with Leukemia, Myeloid. Measurement will happen over the course of During Cycle 1 (30 days in dose escalation part and 28 days in expansion part).

Day 30
Number of patient with dose limiting toxicity (DLT)
Year 3
Cumulative Incidence or Relapse
Year 3
Overall Survival
Year 3
Event Free Survival
Month 1
Best Response Rate per modified International Working Group criteria
Change of clinical response to HM43239 per modified International Working Group criteria
Year 3
Duration of Response
Day 28
Area Under the Concentration-Time Curve (AUC)
Maximum Serum Concentration (Cmax)
Time to maximum concentration (Tmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Myeloid

Trial Design

1 Treatment Group

HM43239
1 of 1
Experimental Treatment

This trial requires 120 total participants across 1 different treatment group

This trial involves a single treatment. HM43239 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

HM43239
Drug
This phase 1/2 study consists of dose escalation and expansion. Dose escalation cohort is planned up to 10 dose levels. If subject in the dose escalation cohort at any dose level achieves clinical response then the dose level will continue to enroll.

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of achievement of a remission until the date of relapse, assessed up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of achievement of a remission until the date of relapse, assessed up to 3 years for reporting.

Closest Location

MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Myeloid or one of the other 3 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:
Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent including privacy language as per national regulations (e.g., HIPAA Authorization for U.S. site) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
Patient is ≥ 18 years of age (or country's legal age of majority if the legal age was > 18 years) at the time of obtaining informed consent.
Refractory to at least 1 cycle of prior therapy
Relapsed after achieving remission with a prior therapy
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patient's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). (upon discussion with the Medical Monitor, shorter than stated washout period may be considered provided that the patient has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies)
Patient must meet the following criteria as indicated on the clinical laboratory tests
Serum aspartate aminotransferase(AST) and alanine aminotransferase(ALT) ≤ 2.5× institutional upper limit normal (ULN)
Total serum bilirubin ≤ 1.5× institutional ULN
Serum creatinine ≤ 1.5× institutional ULN or an estimated glomerular filtration rate (eGFR) of > 60 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation.

Patient Q&A Section

What causes leukemia?

"The exact causes of leukemia are unknown. Genetic, chemical, nutritional, or viral exposure do not appear to be the main risk factors for acute myeloid leukemia at least in the general population. It is thought most cases are caused by an inherited susceptibility to this leukemogenic disease and not by exposure to environmental carcinogens in an individual who has no known family history of leukemia. Genetic studies suggest many genes can become mutated or overexpressed in a single person, leading to the development of acute myeloid leukemia. Other factors such as smoking or infection may increase the risk of developing the disease. Smoking alone is also a risk factor. Exposure to ionizing radiation, hereditary factors, or gene mutations may also cause acute myeloid leukemia." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"At this time, we can’t cure leukemia but we can use our data to find the optimal treatments. The goal is to find a cure and one that is most effective, effective and has the lowest toxic effect" - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"Leukemia is a type of cancer of the blood and bone marrow that originates from hematopoietic stem cells. Leukemia may also be classified by the type of cells involved in the cancer. It accounts for approximately 1% of all cancers diagnosed in the UK. leukemias are usually treated primarily with chemotherapy, and some patients may receive bone marrow transplantation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"Most patients with leukemia undergo treatment, most often a bone marrow [transplant](https://www.withpower.com/clinical-trials/transplant) (BMT), a chemotherapy drug regimen, or a combination of these. Treatment options may also include an interstitial radiation therapy dose. Other options include a stem cell transplant or gene therapy. A few patients will have their disease cured with BMT, a chemotherapy drug regimen, or gene therapy.\n" - Anonymous Online Contributor

Unverified Answer

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

"Current U.S. Bureau of Census-derived data do not provide a complete population-based picture of the incidence and outcomes of AML since it does not reflect the prevalence of patients living in remote areas of the country or those who have succumbed to the devastating effects of late-stage treatments. Moreover, many people with AML might not be reported to their primary healthcare providers. The need for the development of comprehensive data on AML outcomes that can be used in comparative analyses is urgently required." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia?

"Most patients with leukemia may have none of the above criteria. They often present with unexplained blood changes or unexplained white blood cell abnormalities without history of a malignancy, but this situation is relatively common. A careful history is mandatory in all cases." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing leukemia?

"There is an overall small risk of developing leukemia. This risk is dependent on age and specific cancer types. But the risk is not zero and is much worse than that of having a normal lifetime expectancy." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia?

"The survival rate for acute leukemia is similar among all age groups, with the exception of those < 40 years old (see Figure 2). Most deaths result from treatment-related causes. Survival rates for acute leukemias have improved over the last 3 decades although the exact reasons for this improvement remain unknown. Patients with chronic leukemias have good survival rates." - Anonymous Online Contributor

Unverified Answer

How does hm43239 work?

"Hm43239 is a first-stage Hh pathway inhibitor that inhibits the activity of GLI family genes through interactions with chromatin. Because this study is the first demonstration of drug effects of Hh inhibitors, similar to Hh inhibitors used in cancer patients, the mechanisms of inhibition of Hh signaling should be further examined and potentially lead ultimately to a new class of anti-cancer drugs" - Anonymous Online Contributor

Unverified Answer

What is hm43239?

"It was concluded that Hm43239 is a new antigen found in acute lymphoblastic leukemia, diffuse chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia and T-Cell acute lymphoblastic leukemia." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of hm43239?

"The side effects of this compound for patients who have leukemia or lymphoma can be many and vary. These can include headache, dizziness, vertigo, fatigue, nausea, vomiting, diarrhea, vomiting blood, constipation and hypotension, fever or chills and chest tightness or cough. Patients should discuss all of this with their doctor and should remember them for a period of time after they disappear. These side effects should not be confused with the ones listed above, which are generally not related to the treatment. It is important that the patients understand how the drugs can affect them and be prepared when they do. Patients should discuss their medications with their doctor and remember everything. It is important to report the side effects to your doctor immediately." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving hm43239?

"A human monoclonal antibody (hm43239) with a high binding specificity for the P2X subfamily of P2X purinoceptors, and with activity against several other P2X purinoceptor subtypes was developed. It was capable of causing anaphylaxis when infused in the rat or in man. A Phase I clinical trial study was undertaken in USA and UK, but was stopped. As of this writing, no human clinical trials have been reported. The drug was developed by Prof David Nutt of University College London, UCL." - 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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