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

NCT03181815 | Unknown Phase 2

• 1 other identifier: C-CAG in AML
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia; Relapse Leukemia

Keywords

CLADRIBINE; ACUTE MYELOID LEUKEMIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From initiation of C-CAG treatment to end of the study (about within 3 months since enrollment)

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: Cladribine; Drug: G-CSF; Drug: Aclarubicin; Drug: Cytarabine

Interventions

Cladribine DRUG

5mg/㎡ d1-5

Also known as: cladribine injection

treatment arm

G-CSF DRUG

300ug d0-9

Also known as: granulocyte

treatment arm

Aclarubicin DRUG

10mg d3-6

Also known as: Aclacinomycin

treatment arm

Cytarabine DRUG

10mg/㎡ q12h SC d3-9

Also known as: Ara-C

treatment arm

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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; 垫·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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Liang Wang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cladribine; Granulocyte Colony-Stimulating Factor; Aclarubicin; aclacinomycins; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides

Study Officials

• Liang Wang, M.D.

  Sun Yat-sen Univerisity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, M.D.

CONTACT

+862087342439; wangliang@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

CN (1)