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

NCT03318419 | Unknown Phase 2

• 1 other identifier: ALL-2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• CR rate

  Complete Remission: less than 5% blasts in bone marrow

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

Study Arms (1)

Cladribine group

EXPERIMENTAL

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

Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Drug: Pegaspargase

Interventions

Cladribine DRUG

5mg/㎡ d1-5

Also known as: cladribine injection

Cladribine group

G-CSF DRUG

300ug d0-14

Also known as: granulocyte

Cladribine group

Cytarabine DRUG

10mg/㎡ q12h SC d1-14

Also known as: Ara-C

Cladribine group

Pegaspargase DRUG

2500U/m2 im d1

Also known as: Pegaspargase injection

Cladribine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cladribine; Granulocyte Colony-Stimulating Factor; Cytarabine; pegaspargase

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides

Study Officials

• yue lv, MD.

  sun-yat sun university cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hua wang, MD.

CONTACT

wanghua@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)