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

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Brief Title

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

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

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
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

CR rate


Condition

Acute Lymphoblastic Leukemia

Intervention

Cladribine

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

January 1, 2016

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2019

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

yue lv, MD., , [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03318419

Organization ID

ALL-2017


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

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


Verification Date

August 2019