Is NCT03850574 recruiting in Los Angeles, CA?

Yes, NCT03850574 is currently recruiting participants at its Los Angeles, CA location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Los Angeles, CA

About This Acute Myeloid Leukemia Study in Los Angeles

The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with

Sponsor: Aptose Biosciences Inc.

Who Can Participate

Inclusion Criteria

for Parts A/B/C:

Study participant is defined as having morphologically documented primary or secondary AML, MDS-IB2 (≥ 10% bone marrow blasts), or CMML by the World Health Organization (WHO) criteria (2016), and fulfills one of the following:

Refractory to at least 1 cycle of prior therapy

Relapsed after achieving remission with a prior therapy

Study participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Study participant'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), at 4 weeks for biologic or cellular immunotherapies, or 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, a shorter than stated washout period may be considered provided that the study participant has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies.

Study participant must meet the following criteria as indicated on the clinical laboratory tests.

Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× institutional upper limit normal (ULN)

Total serum bilirubin ≤ 1.5× institutional ULN

Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of \> 45 mL/min.

Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)

Female study participants must be either:

Of non-childbearing potential

Post-menopausal (defined as at least 1 year without any menses) prior to screening, or

Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)

Or, if of childbearing potential,

Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and

Must use an acceptable highly effective method of birth control starting at screening and throughout the study period and for 90 days after the final study drug administration.

Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration

Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.

Male study participants and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at screening and continue throughout the study period and for 90 days after the final study drug administration.

Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.

Study participant agrees not to participate in another interventional study while on treatment.

Exclusion Criteria

for Parts A/B/C: Study participants must not enter the study if any of the following exclusion criteria are met:

Study participant was diagnosed with acute promyelocytic leukemia (APL).

Study participant has known BCR-ABL-positive leukemia.

Study participant has an active malignancy other than AML, MDS-IB2, or CMML.

Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML, MDS-IB2, or CMML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)

Study participant has had hematopoietic stem cell transplant (HSCT) and meets any of the following criteria:

Has undergone HSCT within the 2-month period prior to the first study dose

Has clinically significant graft-versus-host-disease (GVHD) requiring treatment

Has ≥ Grade 2 persistent non-hematological toxicity related to the transplant

Had a donor lymphocyte infusion (DLI) ≤ 30 days prior to the first study dose.

Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.

Study participant has disseminated intravascular coagulation abnormality (DIC).

Study participant has had major surgery within 4 weeks prior to the first study dose.

Study participant has had radiation therapy within 4 weeks prior to the first study dose.

Study participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or study participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.

Study participant has any of the following cardiac abnormalities of history:

Study participant has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval \> 250 milliseconds (ms).

Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \> 450 ms in three successive screening measurements.

Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.

Study participant is known to have active infection including any identified active COVID-19 infection.

Study participant is known to have human immunodeficiency virus infection.

Study participant has known active hepatitis B or C, or other active hepatic disorder.

Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation.

Study participant has a history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor. Inclusion Criteria for Part D:

Study participant is defined as having morphologically documented newly diagnosed previously untreated primary or secondary AML by the World Health Organization (WHO) criteria (2016) and considered ineligible to receive intensive chemotherapy. Study participants ≥ 75 years of age are considered ineligible to receive intensive chemotherapy if they meet any of the following criteria:

ECOG Performance Status of 2 or 3;

Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina;

Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%;

Creatinine clearance ≥ 30 mL/min to \< 45 ml/min;

Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0×ULN;

Any other comorbidity that the Investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor during screening and prior to treatment. Study participants are considered ineligible to receive intensive chemotherapy based on their age being ≥ 75 years.

Study participant \< 75 years has an ECOG performance status ≤ 2; study participant ≥ 75 years has an ECOG performance status 0-2.

Study participant must meet the following criteria as indicated on the clinical laboratory tests:

Serum AST and ALT ≤ 3× institutional ULN unless considered due to leukemic organ involvement.

Total serum bilirubin ≤ 3x institutional ULN unless considered due to leukemic organ involvement for study participants \< 75 years; total serum bilirubin ≤ 1.5x institutional ULN (or ≤ 3x institutional ULN if documented history of Gilbert's syndrome) unless considered due to leukemic organ involvement for study participants ≥ 75 years.

Creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 30 mL/min for study participants \< 75 years; creatinine clearance as calculated by the Cockcroft-Gault formula or measured by 24-h urine collection of ≥ 45 mL/min for study participants ≥ 75 years.

Study participant is suitable for oral administration of study drug and has minimum life expectancy (≥ 3 months)

Female study participants must be either:

Of non-childbearing potential

Post-menopausal (defined as at least 1 year without any menses) prior to screening, or

Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening)

Or, if of childbearing potential,

Must have a negative serum or urine pregnancy test at screening (within 72 hours prior to start of treatment), and

Must use an acceptable highly effective contraception starting at screening and throughout the study period and for 90 days after the final study drug administration.

Female study participants must not be breastfeeding at screening and during the study period, and for 90 days after the final study drug administration.

Female study participants must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.

Male study participants must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.

Study participant agrees not to participate in another interventional study while on treatment. Exclusion Criteria for Part D: Study participants must not enter the study if any of the following exclusion criteria are met:

Study participant was diagnosed with acute promyelocytic leukemia (APL).

Study participant has known BCR-ABL-positive leukemia.

Study participant has an active malignancy other than AML.

Study participant has received treatment with the following:

An HMA, VEN (or other BCL-2 inhibitor), a tyrosine kinase inhibitor (TKI), a FLT3 inhibitor (FLT3i), a hematopoietic stem cell transplant (HSCT), and/or a chemotherapeutic agent for antecedent myeloid neoplasm (Note: Prior chemotherapy for solid tumors considered in remission is allowed.)

CAR-T cell therapy

Experimental therapies for antecedent myeloid neoplasms

Current participation in another research or observational study

Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from treatment for antecedent myeloid neoplasms (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, immunosuppressive therapy, radiation, or surgery).

Study participant has meningeal or central nervous system (CNS) involvement with leukemia or other CNS disease related to underlying and secondary effects of malignancy.

Study participant has disseminated intravascular coagulation abnormality (DIC).

Study participant has had major surgery within 4 weeks prior to the first study dose.

Study participant has had radiation therapy within 4 weeks prior to the first study dose.

Study participant has any of the following cardiac abnormalities of history:

Study participant has a mean QT interval (QTc) by Friderica's method (QTcF) \> 450 ms in three successive screening measurements.

Study participant has any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as congenital long QT, syndrome, family history of long QT syndrome.

Study participant is known to have active infection, including any identified active COVID-19 infection.

Study participant is known to have human immunodeficiency virus infection.

Study participant has known active hepatitis B or C, or other active hepatic disorder.

Study participant has any condition which, in the Investigator's opinion, makes the study participant unsuitable for study participation, including a chronic respiratory disease that requires continuous oxygen, or a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, or cardiovascular disease, or any other medical condition or known hypersensitivity to any of the study medications including excipients of VEN and AZA that in the opinion of the Investigator would adversely affect participating in this study.

Study participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal) or other medical conditions (e.g., infection, heart failure, COPD flare, etc.).

Study participant has a white blood cell count \> 25 × 10\^9/L. (Treatment with hydroxyurea or use of leukapheresis are permitted to meet this criterion.)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT03850574) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Los Angeles, CA

If you're searching for acute myeloid leukemia treatment options in Los Angeles, CA, this clinical trial (NCT03850574) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Los Angeles, CA

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