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Aclarubicin

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Ara-C, Aclarubicin Combined PEG-G-CSF

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, PEG-G-CSF 6mg subcutaneously on days 0. One course includes 28 days.

Ara-C, Aclarubicin Combined G-CSF

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14, Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8, G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14. G-CSF was postponed or interrupted in case of white blood cell (WBC) count greater than 20 × 109/L .

One course includes 28 days.

ARA-C subcutaneously in a 12-hour infusion on days 1 through 14

AraC

Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8

Peg-G-CSF

G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.

G-CSF

Ming Hou, Docter

Ming Hou

Most of patients with acute myeloid leukemia (AML) are elder and have poor prognosis despite induction chemotherapy.The regimen of cytarabine(Ara-C), aclarubicin and G-CSF (CAG regimen ) has been widely used in China for the treatment of acute myeloid leukemia (AML). Strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. Granulocyte colony-stimulating factor(G-CSF) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． Pegylated granulocyte colony-stimulating factor (PEG-G-CSF )is a long-acting reagent that permits less frequent injection．The project is undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China.In order to report the efficacy and safety of PEG-G-CSF combined with Ara-C and aclarubicin for the treatment of Acute Myeloid Leukemia, compared to the regimen of Ara-C, aclarubicin and G-CSF (CAG ).

The Investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed AML (not APL) patients in China. Participants are randomised selected to receive the regimen of Ara-C, aclarubicin and PEG-G-CSF , or the regimen of Ara-C, aclarubicin and G-CSF (CAG ).Platelet count, bleeding and other symptoms are evaluated before and after treatment. Adverse events are also recorded throughout the study.

Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients

A Multi-center Randomized Open-label Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of Acute Myeloid Leukemia Patients

Bone marrow blasts not more than 5%, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count more than 1\*10\^9/L, platelet count more than 100\*10\^9/L,independence of red cell transfusions

Shandong University

Professor and Director

Cladribine

Aclacinomycins

The patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following: Cladribine 5mg/㎡，d1-5；G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle

Liang Wang, M.D.

The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

AML is most common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia

Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Aclarubicin in Patients With Refractory/Relapsed Acute Myeloid Leukemia: a Phase 2 Clinical Trial

Less than 5% of blast cells in bone marrow aspiration is defined as CR.

The hematologic toxicities and non-hematologic toxicities will be graded according to CTCAE version 3.0

Sun Yat-sen University

Professor

cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle.

Cladribine 5 mg/m2, intravenous drip,d1-5,4 weeks per cycle.

Cladribine Injection

aclarubicin 10 mg, intravenous drip,d3-6,4 weeks per cycle.

G-CSF 300 µg,subcutaneous injection, d0-9,4 weeks per cycle.

cytarabine 10mg/ m2, subcutaneous injectionq,q12h, d3-9,4 weeks per cycle.

cytarabine

wang hua, MD.

hua wang, MD.

In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in elderly patients with AML.

The low-intensity chemotherapy were developed to reduce the early mortality and improve the benefit-risk ratio for longterm survival in elderly or unfit AML patients.Previous studies revealed that the standard dose of CAG regimen consisting of low-dose cytarabine and aclarubicin in combination with granulocyte colonystimulating factor (G-CSF) priming as an induction therapy was well-tolerated by patients and led to a complete remission (CR) rate of 50.0% in patients aged≥ 70 years. Cladribine (2-chlorodeoxyadenosine ) is a nucleoside analogue of anti-adenosine deaminase that has extensive antitumor activity in hematological tumor.The purine analog 2-CdA increases the uptake of Ara-C and the accumulation of its active cytotoxic metabolite 5α-triphosphate Ara-C (Ara-CTP) in leukemia cells. This finding suggests that synergy occurs between cladribine and cytarabine. In this study, the investigators conducted a phase II trial that evaluated the efficacy and safety of cladribine in combination with modified CAG regimen (low-dose cytarabine and aclarubicin) in unfit patients with AML.Patients will receive C-CAG regimen as follows: cladribine 5 mg/m2, d1-5; G-CSF 300 µg, d0-9; aclarubicin 10 mg, d3-6; cytarabine 10mg/ m2 q12h, SC, d3-9; 4 weeks per cycle. The participants are permitted to quit the study if complete remission (CR) was not achieved after two courses of chemotherapy.The participants will be treated for a total of six cycles unless disease progression or unacceptable side effects are observed or participants withdrew their consent.

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Efficacy and Safety of Cladribine in Combination With G-CSF,Low-dose Cytarabine and Aclarubicin in Newly Diagnosed Unfit Patients With Acute Myeloid Leukemia

Safety and tolerability of Cladribine in Combination With treatment for CAG for AML (type, frequency, severity and relationship of adverse events to study treatment).

The time from registration to induction failure, death or relapse whichever occurs first

The time from the date of registration to the date of death, whatever the cause. Patients still alive at the date last contact will be censored.

Assessment of the prognostic value of Minimal Residual Disease (MRD) by flowcytometry or PCR

Director, Head of hematology, Principal Investigator, Clinical Professor

Venetoclax

Azacitidine

Induction: Subjects who meet the enrollment conditions will receive Venetoclax plus Azacitidine and CAG(VA-CAG) . Participants will receive this induction Therapy as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.

Consolidation: If patients are intermediate or poor risk and have plans for allogeneic hematopoietic stem-cell transplantation(allo-HSCT) , high dose cytarabine (3g/m2 q12h days 1-3) for 1-2 cycles and follow up with allo-HSCT. In other cases, high dose cytarabine for 4 cycles.

Induction:

VA regimen：

Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21);

Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

CAG regimen：

Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7;

Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7;

Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC \>20×10\^9/L；

Consolidation:

Drug: Cytarabine 3g/m2 q12h on days 1-3.

Venetoclax in combination with azacitidine and CAG

Sanbin Wang, MD

Lin Liu, MD

Lin Liu

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).

This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (AML).

The combination of venetoclax and azacitidine is the standard therapy for elderly (\> 60 year old) patients with newly diagnosed AML who are not eligible for intensive chemotherapy. Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. The preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for newly diagnosed young patients with AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 62 patients will take part in this trial.

A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

A Phase II Study to Evaluate the Safety and Efficacy of Venetoclax in Combination With Azacitidine and CAG(VA-CAG) as Induction Therapy in Newly Diagnosed Patients With Acute Myeloid Leukemia(AML)

The overall remission rate (ORR) was defined as the percentage of patients who achieved complete remission (CR), complete remission with incomplete count recovery (CRi), or morphologic leukemia free state (MLFS) per the International Working Group criteria for AML.

Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

The duration of absolute value of peripheral blood neutrophils \<0.5×10\^9/L and platelet count \<50×10\^9/L during myelosuppression.

Leukaemia-free survival will be defined as the time since date of CR until either relapse or death in remission.

Overall Survival will be defined as the time from administration of the initial doses until death from any cause.

Percentage of participants who converted to MRD \< 10\^-3 by flow cytometry before initiation of consolidation therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Ara-C, Aclarubicin Combined With PEG-G-CSF for Initial Treatment of AML Patients	NCT03045627	Acute Myeloid L...	AraC Aclarubicin Peg-G-CSF G-CSF	60 Years - 75 Years	Shandong University
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia	NCT03181815	Acute Myeloid L... Relapse Leukemi...	Cladribine G-CSF Aclarubicin Cytarabine	15 Years - 75 Years	Sun Yat-sen University
Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML	NCT04254640	Acute Myeloid L... Elderly Patient... Newly Diagnosed	Cladribine Inje... Aclarubicin G-CSF cytarabine	18 Years - 90 Years	Sun Yat-sen University
A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients	NCT05662956	Acute Myeloid L...	Venetoclax in c...	18 Years - 65 Years	Hematology department of the 920th hospital
Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML	NCT04254640	Acute Myeloid L... Elderly Patient... Newly Diagnosed	Cladribine Inje... Aclarubicin G-CSF cytarabine	18 Years - 90 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for aclarubicin

Every month we try and update this database with for aclarubicin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aclarubicin

Every month we try and update this database with for aclarubicin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aclarubicin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.