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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181815
• Other study ID #: C-CAG in AML
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: Liang Wang, M.D.
• Phone: +862087342439
• Email: wangliang[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women;

• Clinical diagnosis of Relapsed/Refractory AML (non-APL);

• ECOG performance status (PS) score 0-3;

• AST and ALT <=2.5 times the institutional ULN;

• Total bilirubin <=2.0 times the institutional ULN

• Serum creatinine<2.0 times the institutional ULN;

• Subjects should take effective contraceptive measures,and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects;

• Patients should understand the disease and voluntarily receive the study regimen and follow-up.

Exclusion Criteria:

• Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);

• Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;

• Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;

• Subjects suffered from AIDS,active hepatitis B or C virus infection; ?·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;

• Be allergic to any component of C-CAG regimen;

• Subjects ever exposed to cladribine or CAG-based regimen.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Relapse Leukemia

Intervention

Drug:
• Cladribine
5mg/? d1-5
• G-CSF
300ug d0-9
• Aclarubicin
10mg d3-6
• Cytarabine
10mg/? q12h SC d3-9

Locations

Country	Name	City	State
China	Liang Wang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission (CR) rate	Less than 5% of blast cells in bone marrow aspiration is defined as CR.	Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The hematologic toxicities and non-hematologic toxicities will be graded according to CTCAE version 3.0	From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment)