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

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ClinicalTrials.gov Identifier: NCT03318419
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
dr. luyue, Sun Yat-sen University

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
Acute Lymphoblastic Leukemia Drug: Cladribine Drug: G-CSF Drug: Cytarabine Drug: Pegaspargase 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : January 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


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 Name: cladribine injection

Drug: G-CSF
300ug d0-14
Other Name: granulocyte

Drug: Cytarabine
10mg/㎡ q12h SC d1-14
Other Name: Ara-C

Drug: Pegaspargase
2500U/m2 im d1
Other Name: Pegaspargase injection




Primary Outcome Measures :
  1. CR rate [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318419


Contacts
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Contact: hua wang, MD. wanghua@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: yue lu, MD.    0086-02087342438    dr_luyue@sina.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: yue lv, MD. sun-yat sun university cancer center

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Responsible Party: dr. luyue, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03318419     History of Changes
Other Study ID Numbers: ALL-2017
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Cladribine
Pegaspargase
Asparaginase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs