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

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cladribine

G-CSF

Cytarabine

Pegaspargase

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cladribine group

Arm Description

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

Outcomes

Primary Outcome Measures

CR rate

Complete Remission: less than 5% blasts in bone marrow

Secondary Outcome Measures

Full Information

NCT ID

NCT03318419

First Posted

October 18, 2017

Last Updated

August 18, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03318419

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

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, 2020 (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 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.

6. Conditions and Keywords

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

Acute Lymphoblastic 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

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cladribine group

Arm Type

Experimental

Arm Description

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

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 d0-14

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Ara-C

Intervention Description

10mg/㎡ q12h SC d1-14

Intervention Type

Drug

Intervention Name(s)

Pegaspargase

Other Intervention Name(s)

Pegaspargase injection

Intervention Description

2500U/m2 im d1

Primary Outcome Measure Information:

Title

CR rate

Description

Complete Remission: less than 5% blasts in bone marrow

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

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

hua wang, MD.

wanghua@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yue lv, MD.

Organizational Affiliation

sun-yat sun university cancer center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

GuangZhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

yue lu, MD.

Phone

0086-02087342438

dr_luyue@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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