A Phase 2 interventional study of CACAG+VEN and 3+7 in Acute Monocytic Leukemia, sponsored by Chinese PLA General Hospital. Recruiting at 3 sites in China. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Chinese PLA General Hospital · Phase 2, Interventional, and Treatment
Among 50 studies testing cytarabine in Leukemia, Monocytic, Acute — 3 open to participants now, 4 under way, 1 of them phase 3. Cytarabine · Leukemia, Monocytic, Acute.
Among the 50 studies testing cytarabine in Leukemia, Monocytic, Acute, this one is the 3rd largest by planned enrollment of the 48 interventional ones that give a count, is one of 2 that started in 2025, is one of 20 in phase 2, and was the 50th registered.
194 studies on the registry are indexed under Leukemia, Monocytic, Acute; 12 are open to participants now.
Browse Leukemia, Monocytic, Acute studies →3 of the 50 studies testing cytarabine in Leukemia, Monocytic, Acute are open now, in 2 countries. Recruiting first, the newest first:
OHSU Knight Cancer Institute · Sites in United States
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 1 mo–14 yrs
By country, each count listing its studies:
Cytarabine: first FDA approval 1969 (CYTARABINE), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
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: 14 Years to 60 Years · 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.
50 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 23 · Phase 2 27 · Phase 3 4
First in 1994; 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 204 is above the median of 42 across 158 interventional studies indexed under Leukemia, Monocytic, Acute.
Median enrollment 48 across the 48 interventional studies. Of the 42 that completed or were terminated, 15 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 50 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 1 study filed under Leukemia, Monocytic, Acute — fewer than ten, so there is no comparison to draw.
1 of the studies testing cytarabine in Leukemia, Monocytic, Acute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| 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 |
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Among the 50 studies testing cytarabine in Leukemia, Monocytic, Acute, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:
Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.
Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.
The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.
The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles.
Drug: CACAG+VEN
Participants assigned toStandard "3+7" Regimen will receive the standard "3+7" induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines.
Drug: 3+7
Drug pages: Azacitidine · Cytarabine · Aclacinomycins · Tucidinostat · Venetoclax · Granulocyte Colony-Stimulating Factor
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.
IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Composite Complete Remission Rate
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC \<1.0×10⁹/L) or thrombocytopenia (platelets \<100×10⁹/L).
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission Rate after Cycle 1
Proportion of participants achieving complete remission (CR) after one cycle of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 1
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after one cycle of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate after Cycle 1
Proportion of participants achieving overall response after one cycle of treatment. Overall response is defined as the sum of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Partial Remission Rate after Cycle 1
Proportion of participants achieving partial remission (PR) after one cycle of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 1
Proportion of participants achieving minimal residual disease (MRD) negativity after one cycle of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Composite Complete Remission Rate after Cycle 1
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after two cycles of treatment.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission Rate after Cycle 2
Proportion of participants achieving complete remission (CR) after two cycles of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 2
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after two cycles of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L).
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Partial Remission Rate after Cycle 2
Proportion of participants achieving partial remission (PR) after two cycles of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 2
Proportion of participants achieving minimal residual disease (MRD) negativity after two cycles of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Progression-Free Survival
The time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression is defined according to standard criteria for acute monocytic leukemia.
Time frame: Up to 12 months after enrollment
Overall Survival
The time from enrollment to death from any cause. For surviving participants, data will be censored at the date of last follow-up.
Time frame: Up to 12 months after enrollment
Relapse Rate
The proportion of participants who achieve remission (CR or CRi) and subsequently experience disease relapse during the follow-up period. Relapse is defined according to standard criteria for acute monocytic leukemia.
Time frame: Up to 12 months after enrollment
Duration of Remission
The time from the first documented remission (CR or CRi) to disease relapse or death from any cause, whichever occurs first.
Time frame: Up to 12 months after enrollment
Adverse reactions in hematology
Record of adverse events in hematological system during and after treatment
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Nonhematological adverse reactions
Record of adverse events in other organs or systmes during and after treatment
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Started Sep 2025 (actual). Primary completion is estimated for Sep 2028, 36 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 36 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Azacitidine · Cytarabine · Aclacinomycins · Tucidinostat · Venetoclax · Granulocyte Colony-Stimulating Factor
Chinese PLA General Hospital →