Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03318419
Collaborator
(none)
50
1
1
60
0.8

Study Details

Study Description

Brief Summary

The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL.Our previous experience has shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) 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 Pegaspargase (C-GAP) in patients with refractory/relapsed acute Lymphoblastic Leukemia

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

ALL is common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL. Our previous experience has shown that Cladribine in combination of GAP(G-CSF priming, low dose cytarabine, and Pegaspargase) 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 :
50 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 Pegaspargase in Patients With Refractory/Relapsed Acute Lymphoblastic 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, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cladribine group

Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm

Drug: Cladribine
5mg/㎡ d1-5
Other Names:
  • cladribine injection
  • Drug: G-CSF
    300ug d0-14
    Other Names:
  • granulocyte
  • Drug: Cytarabine
    10mg/㎡ q12h SC d1-14
    Other Names:
  • Ara-C
  • Drug: Pegaspargase
    2500U/m2 im d1
    Other Names:
  • Pegaspargase injection
  • Outcome Measures

    Primary Outcome Measures

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

      Complete Remission: less than 5% blasts in bone marrow

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Men and women;

    • Clinical diagnosis of Relapsed/Refractory ALL;

    • 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 ALL, 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-GAP regimen;

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center GuangZhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: yue lv, MD., sun-yat sun university cancer center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    dr. luyue, professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03318419
    Other Study ID Numbers:
    • ALL-2017
    First Posted:
    Oct 23, 2017
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2019