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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03341 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0890 | Other Identifier | M D Anderson Cancer Center |
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The study terminated early because the company was longer providing the investigational product.
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This phase Ib/II trial best dose, possible benefits and/or side effects of omacetaxine and venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (recurrent) or does not respond to treatment (refractory) and have a genetic change RUNX1. Drugs used in chemotherapy, such as omacetaxine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving omacetaxine and venetoclax may help to control the disease.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability and recommended phase 2 dose (RP2D) of omacetaxine in combination with venetoclax for patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation. (Phase 1b) II. To determine the efficacy of omacetaxine in combination with venetoclax for patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome harboring a RUNX1 mutation. (Phase II)
SECONDARY OBJECTIVES:
I. To determine duration of response (DOR), event-free survival (EFS), and overall survival (OS).
II. To evaluate occurrence of minimal residual disease (MRD) negative status by multiparameter flow cytometry and molecular evaluation.
OUTLINE: This is a phase I, dose de-escalation study followed by a phase II study.
Patients receive omacetaxine subcutaneously (SC) twice daily (BID) on days 2-3 or 2-4, and venetoclax orally (PO) on days 1-7, 1-10 or 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days, then every 3 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ph 1 Arm A (AML) Dose 0 | Experimental | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Ph 1 Arm B (MDS) Dose 0 | Experimental | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Ph 1 Arm A (AML) Dose +1 | Experimental | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Ph 1 Arm B (MDS) Dose + 1 | Experimental | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Ph 2 Arm A (AML) Dose +1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacetaxine Mepesuccinate | Drug | Given SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) of Omacetaxine in Combination With Venetoclax | The RP2D will be selected at the end of the Phase 1b portion based on safety data , in Arms A and B independently. Preliminary efficacy and PK data for each dose level may also be considered as appropriate. | Up to 30 days |
| Number of Participant to Achieve Complete Remission | Complete Remission for AML is defined as: Absolute neutrophil count > 10^3/UL, platelets . 10^5/UL, red cell transfusion independence, absence of extramedullary disease, and bone marrow with < 5% blasts. Complete Remission for MDS is defined as: Absolute neutrophil count > 10^3/UL, platelets . 10^5/UL, hemoglobin >11 g/dl, and bone marrow with < 5% blasts. Peripheral dysplasia will be noted. | At day 28, and 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | Time from date of treatment start until the date of failure or death from any cause. | Up to Two years, 8 months, 30 days |
| Overall Survival (OS) | The Kaplan-Meier method will be used to estimate the probabilities. Log-rank tests will be used to compare among subgroups of patients in terms of OS. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
Patients with any concurrent uncontrolled clinically significant medical condition including active infection or psychiatric illness, which could place the patient at unacceptable risk of study treatment
Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and/or phototherapy for chronic skin GVHD are permitted after discussion with the PI)
Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or known human immunodeficiency virus (HIV) infection
Subject has a white blood cell count > 25 x 10^9/L. (Note: Hydroxyurea is permitted to meet this criterion.)
Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception
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| Name | Affiliation | Role |
|---|---|---|
| Courtney DiNardo, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40979071 | Derived | DiNardo CD, Jen WY, Montalban-Bravo G, Wang X, Loghavi S, Lavu S, Short NJ, Chien K, Issa GC, Pemmaraju N, Yilmaz M, Andreeff M, Borthakur G, Kadia TM, Daver NG, Garcia-Manero G, Mill CP, Su X, Fiskus W, Bhalla KN. Omacetaxine and venetoclax in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with mutant RUNX1. Blood Neoplasia. 2025 Jul 25;2(4):100145. doi: 10.1016/j.bneo.2025.100145. eCollection 2025 Nov. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ph 1 Arm A (AML) Dose 0 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2024 |
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| Experimental |
Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
| Ph 2 Arm B (MDS) Dose + 1 | Experimental | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
|
| Venetoclax | Drug | Given PO |
|
|
| Up to Two years, 8 months, 30 days |
| Duration of Response | Response date to loss of response or last follow up. | Up to Two years, 8 months, 30 days |
| Ph 1 Arm B (MDS) Dose 0 |
Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| FG002 | Ph 1 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| FG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| FG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| FG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| COMPLETED |
|
| NOT COMPLETED |
|
study moved to the phase 2 portion, with 10 AML patients treated at the RP2D. Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ph 1 Arm A (AML) Dose 0 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG001 | Ph 1 Arm B (MDS) Dose 0 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG002 | Ph 1 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) of Omacetaxine in Combination With Venetoclax | The RP2D will be selected at the end of the Phase 1b portion based on safety data , in Arms A and B independently. Preliminary efficacy and PK data for each dose level may also be considered as appropriate. | RP2D was only assessed in the phase 1 portion of the study. In the phase 1b portion of the MDS arm, 2 patients were treated at dose level 0 before the study was closed by the sponsor. | Posted | Number | mg/m2 | Up to 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participant to Achieve Complete Remission | Complete Remission for AML is defined as: Absolute neutrophil count > 10^3/UL, platelets . 10^5/UL, red cell transfusion independence, absence of extramedullary disease, and bone marrow with < 5% blasts. Complete Remission for MDS is defined as: Absolute neutrophil count > 10^3/UL, platelets . 10^5/UL, hemoglobin >11 g/dl, and bone marrow with < 5% blasts. Peripheral dysplasia will be noted. | Of the 24 patients enrolled in the study, three were not evaluable for response. One participant in Ph 1 Arm A (AML) Dose 0 was not evaluable for response. Two participants in Ph 2 Arm A (AML) Dose +1 were not available for response. | Posted | Count of Participants | Participants | At day 28, and 3 cycles. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | Time from date of treatment start until the date of failure or death from any cause. | Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor. | Posted | Median | Full Range | Months | Up to Two years, 8 months, 30 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The Kaplan-Meier method will be used to estimate the probabilities. Log-rank tests will be used to compare among subgroups of patients in terms of OS. | Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor. Survival will be presented by median survival, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. | Posted | Median | Full Range | Months | Up to Two years, 8 months, 30 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Response date to loss of response or last follow up. | Due to lack of efficacy during an interim analysis, the AML arm was closed. In the phase 1b portion of the MDS arm, 2 patients were treated before the study was closed by the sponsor. | Posted | Median | Full Range | Month | Up to Two years, 8 months, 30 days |
|
Up to Two years, 8 months, 30 days
There were zero participants at risk for Serious Adverse Events, Other Adverse Events and All-Cause Mortality for Ph 1 ARM B (MDS) Dose +1 and Ph 2 ARM B (MDS) Dose +1 due to the study closing and zero participants being registered on those two arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ph 1 Arm A (AML) Dose 0 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 1 | 3 | 3 | 3 | 1 | 3 |
| EG001 | Ph 1 Arm B (MDS) Dose 0 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-10 . Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 0 | 2 | 2 | 2 | 1 | 2 |
| EG002 | Ph 1 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 1 | 9 | 5 | 9 | 5 | 9 |
| EG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 2 | 10 | 7 | 10 | 4 | 10 |
| EG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-neutropenic fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Failure to thrive | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Right middle cerebellar peduncle and medullary lesion - (Brain Lesions) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Slurred speech | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Altered mental status | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute hypoxic respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cellulitis of the right toe | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney DiNardo MD, Professor | The university of Texas MD Anderson Cancer Center | 713-794-1141 | cdinardo@mdanderson.org |
| Jul 16, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2023 | Sep 20, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015456 | Leukemia, Biphenotypic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077863 | Homoharringtonine |
| D004952 | Esters |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D006248 | Harringtonines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| Ph 1 Arm A (AML) Dose +1 |
Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
|
|
| OG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
|
|
Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
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| OG003 | Ph 1 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG004 | Ph 2 Arm A (AML) Dose +1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
| OG005 | Ph 2 Arm B (MDS) Dose + 1 | Participants receive omacetaxine SC BID on days 2-4, and venetoclax PO on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Omacetaxine Mepesuccinate: Given SC Venetoclax: Given PO |
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