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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03181815
Collaborator
(none)
48
1
1
48
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Study Details

Study Description

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.

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

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
5mg/㎡ d1-5
Other Names:
  • cladribine injection
  • Drug: G-CSF
    300ug d0-9
    Other Names:
  • granulocyte
  • Drug: Aclarubicin
    10mg d3-6
    Other Names:
  • Aclacinomycin
  • Drug: Cytarabine
    10mg/㎡ q12h SC d3-9
    Other Names:
  • Ara-C
  • Outcome Measures

    Primary Outcome Measures

    1. Complete Remission (CR) rate [Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)]

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

    Secondary Outcome Measures

    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)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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; 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liang Wang Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Liang Wang, M.D., Sun Yat-sen Univerisity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liang Wang, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03181815
    Other Study ID Numbers:
    • C-CAG in AML
    First Posted:
    Jun 9, 2017
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liang Wang, Professor, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2019