A Phase 2 interventional study of Azacitidine and Biospecimen Collection in Acute Monocytic Leukemia and Acute Myeloid Leukemia, sponsored by OHSU Knight Cancer Institute. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by OHSU Knight Cancer Institute · Phase 2, Interventional, and Treatment
Among 150 studies in Leukemia, Monocytic, Acute with a site in United States — 8 open to participants now, 12 under way, none of them phase 3. Leukemia, Monocytic, Acute · United States.
Among the 150 studies in Leukemia, Monocytic, Acute with a site in United States, this one is the 62nd largest by planned enrollment of the 132 interventional ones that give a count, is one of 2 that started in 2025, is one of 67 in phase 2, reaches primary completion later than 6 of the 11 other live ones, and was the 148th registered.
194 studies on the registry are indexed under Leukemia, Monocytic, Acute; 12 are open to participants now.
Browse Leukemia, Monocytic, Acute studies →8 of the 150 studies in Leukemia, Monocytic, Acute with a site in United States are open now. Recruiting first, the newest first:
University of Nebraska · Sites in United States
Ages 50+
Solu Therapeutics, Inc · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 18–80
University of Washington · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 1–60
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 12 Leukemia, Monocytic, Acute studies recruiting now, 6 (50%) set no upper age limit and 5 (42%) stop at 75 or younger; 3 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
150 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 59 · Phase 2 78 · Phase 3 14
First in 1987; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 42 across 158 interventional studies indexed under Leukemia, Monocytic, Acute.
Median enrollment 36 across the 132 interventional studies, 600 across the 3 observational. Of the 131 that completed or were terminated, 55 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 150 have an industry lead sponsor. The 10 most frequent:
OHSU Knight Cancer Institute is the lead sponsor of 243 studies on the registry; 44 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
OHSU Knight Cancer Institute has 1 study filed under Leukemia, Monocytic, Acute — fewer than ten, so there is no comparison to draw.
5 of the studies in Leukemia, Monocytic, Acute with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06429449University of Colorado, DenverMitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia | 2026-12 |
| NCT03737955University of WashingtonFractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia | 2026-12-31 |
| NCT06950034Solu Therapeutics, IncA Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML) | 2026-12-31 |
| NCT06504459OHSU Knight Cancer InstituteVenetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML | 2027-10-11 |
| NCT04282187University of WashingtonDecitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms | 2027-11-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 150 studies in Leukemia, Monocytic, Acute with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.
PRIMARY OBJECTIVE:
I. Assess efficacy of the investigational treatment based on disease remission.
SECONDARY OBJECTIVES:
I. Assess efficacy of the investigational treatment based on clinical response. II. Assess any-cause survival after treatment. III. Assess survival in the absence of treatment failure, hematologic relapse, or progressive disease.
IV. Assess duration of response, based on morphological assessments. V. Assess the safety and tolerability of the regimen.
EXPLORATORY OBJECTIVES:
I. Assess response based on measurable residual disease (MRD). II. Identify markers of clonal or clinical response and resistance to treatment.
III. Assess participant quality of life (QoL) using Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO CTCAE).
OUTLINE:
INDUCTION: Patients receive cladribine intravenously (IV) over 1-2 hours on days 1-5, cytarabine subcutaneously (SC) twice daily (BID) or once daily (QD) on days 1-10, and venetoclax orally (PO) on days 1-21 of cycle 1.
RE-INDUCTION: Patients with > 5% blasts after cycle 1 receive cladribine IV over 1-2 hours on days 1-5, cytarabine SC BID or QDon days 1-10, and venetoclax PO QD on days 1-21 of cycle 2.
REMISSION AFTER INDUCTION: Patients who achieve complete remission (CR)/CR with partial hematologic recovery/CR with incomplete blood count recovery/morphologic leukemia-free state (MLFS) after cycle 1 of induction, receive cladribine IV over 1-2 hours on days 1-3, cytarabine SC BID or QD on days 1-10 and venetoclax PO QD on days 1-21 of cycle 2.
CONTINUING THERAPY: Patients who achieve MLFS receive venetoclax PO QD on days 1-21 and azacitidine IV or SC QD on days 1-7 for 2 cycles then cladribine IV over 1-2 hours on days 1-3, cytarabine SQ BID or QD on days 1-10 and venetoclax PO QD on days 1-21 for 2 cycles. Cycles repeat every 28 days and continue to alternate every 2 cycles for up to cycle 18 in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) as clinically indicated on study. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.
At completion of study treatment, patients are followed up for 2 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ability to comprehend the nature of the study and provide (i.e., participant or legally authorized representative [LAR]). Written informed consent must be obtained prior to any study-specific procedures or interventions
Ineligible for standard of care induction therapy using intensive chemotherapy (IC) or unwilling to undergo IC induction therapy. Ineligible for IC is defined as
18-74 yrs of age with one of the following:
If ≥ 75 yrs of age, the following organ function values must be met and ECOG must be 0 to 2 at screening:
(AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN (Unless due to leukemic infiltration) (With the exception of documented Gilbert's syndrome or similar conditions. Liver function testing (LFT) and timepoints may be added, as clinically indicated, in such cases)
Willingness to comply with study requirements for within the specified timeframe, as follows:
Exclusion Criteria:
Use of drugs with documented drug-drug interaction toxicities with the study drugs
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
See Detailed Description
Drug: Azacitidine · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Drug: Cladribine · Drug: Cytarabine · Procedure: Echocardiography · Procedure: Lumbar Puncture · Procedure: Multigated Acquisition Scan · Other: Questionnaire Administration · Drug: Venetoclax
Given IV or SC
Also known as: 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow
Given IV
Also known as: 2-CdA, 2CDA, CdA, Cladribina, Leustat, Leustatin, Leustatine, RWJ-26251
Given SC
Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
Undergo ECHO
Also known as: EC
Undergo LP
Also known as: LP, Spinal Tap
Undergo MUGA
Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning
Ancillary studies
Given PO
Also known as: ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
Composite complete remission (CRc) rate
CRc is defined as achievement of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete blood count recovery (CRi) after induction (or re-induction). The CRc rate will be computed on the safety set and presented with a point-estimate and exact binomial 95% confidence interval (CI). CRc will also be modeled with univariable logistic regressions, applied to the efficacy set, to determine if any baseline patient or disease feature is correlated with clinical response.
Time frame: At start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21. Each cycle is 28 days)
Overall response rate (ORR)
ORR will be defined as the proportion of evaluable participants who attain a partial remission (PR) or better (i.e., CR, CRh, CRi, morphologic leukemia-free state \[MLFS\], or PR) while on investigational treatment. ORR will be computed for both the safety set and the efficacy set and presented with a point estimate and exact binomial CI. ORR will also be modeled with univariable logistic regressions with baseline patient and disease features as predictors and results considered hypothesis-generating.
Time frame: At start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21. Each cycle is 28 days)
Overall survival (OS)
OS will be computed for both the safety set and the efficacy set, and estimated with the Kaplan-Meier method. Median OS and OS rates at common landmark times (e.g., 1 year, 2 years) will be estimated with 95% log-log CIs. For both sets, univariable Cox models will be fit to OS to assess the impact of baseline patient and disease features with results (i.e., unadjusted hazard ratios and Wald test p-values) considered hypothesis-generating. Median follow-up will utilize a patient's OS measurement and censoring status and be estimated using the reverse Kaplan-Meier method.
Time frame: At start of treatment to death up to 2 years
Event-free survival (EFS)
EFS will be measured from start of treatment to the earliest date of treatment failure, progressive disease, or death from any cause. EFS will be estimated for the efficacy set using the Kaplan-Meier method, with median EFS and EFS rates at common landmark times presented with 05% log-log CIs. EFS will be alternatively estimated upon assigning 1-day event times to participants who never achieve MLFS or better. Univariable Cox models will be fit to EFS to assess the impact of baseline patient and disease features with model results considered hypothesis-generating.
Time frame: At start of treatment to primary refractory disease, hematologic relapse, discontinuation of treatment due to toxicity, disease progression or death up to 2 years
Duration of response (DOR)
DOR will be measured from the first date of documented hematologic response to the earliest of the following occurrences: hematologic relapse, disease progression (clinical or morphologic), or any-cause death. DOR will be estimated by the Kaplan-Meier method. Median DOR will be presented with a 95% log-log CI.
Time frame: At first date of documented ≥ MLFS or better to primary refractory disease, hematologic relapse, discontinuation of treatment due to toxicity, disease progression or death up to 2 years
Incidence of grade ≥ 3 adverse events (AEs)
AEs severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: At start of treatment up to 30 days after last dose of any study drug
Percentage of patients achieving 80% relative dose intensity
The percentage of participants achieving 80% relative dose intensity will be reported.
Time frame: At start of treatment to end of treatment up to 1 year and 5 months
Started Jan 2025 (actual). Primary completion is estimated for Oct 2027, 33 months after the start.
Of 19 phase 2 interventional studies under Leukemia, Monocytic, Acute, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 118. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Azacitidine · Cladribine · Cytarabine · Venetoclax
OHSU Knight Cancer Institute →