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

Primary Purpose

Acute Myeloid Leukemia, Relapse Leukemia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cladribine

G-CSF

Aclarubicin

Cytarabine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring CLADRIBINE, ACUTE MYELOID LEUKEMIA

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Liang WangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

Complete Remission (CR) rate

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03181815

First Posted

June 7, 2017

Last Updated

August 18, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03181815

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Relapse Leukemia

Keywords

CLADRIBINE, ACUTE MYELOID LEUKEMIA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cladribine

Other Intervention Name(s)

cladribine injection

Intervention Description

5mg/㎡ d1-5

Intervention Type

Drug

Intervention Name(s)

G-CSF

Other Intervention Name(s)

granulocyte

Intervention Description

300ug d0-9

Intervention Type

Drug

Intervention Name(s)

Aclarubicin

Other Intervention Name(s)

Aclacinomycin

Intervention Description

10mg d3-6

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Ara-C

Intervention Description

10mg/㎡ q12h SC d3-9

Primary Outcome Measure Information:

Title

Complete Remission (CR) rate

Description

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

Time Frame

Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang Wang, M.D.

Phone

+862087342439

wangliang@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liang Wang, M.D.

Organizational Affiliation

Sun Yat-sen Univerisity

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liang Wang

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang Wang, M.D.

Phone

+862087342439

wangliang@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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