Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Soochow University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Cladribine; Drug: Fludarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT05578378

2022027

Details and patient eligibility

About

To explore the efficiency and safety of CLAG regimen in R/R ALL

Full description

R/R Acute Lymphoblastic Leukemia has poor response to second-line chemotherapy.Here,we want to explore efficiency and safety of CLAG regimen in R/R ALL.

Enrollment: 32 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-3. Expecting life span is more than 6 weeks.

Exclusion criteria

Patients are combined with severe organ dysfunction or organ failure: Cardiac failure, Liver and kidney insufficiency.

Patients are combined with severe infection or other complications that can not tolerate chemotherapy.

Patients are considered as other tumor progression. Patients have used cladribine. Pregnant and lactating women will not be included.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

CLAG arm

Experimental group

Description:

Cladribine (5 mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.

Treatment:

Drug: Cladribine

Control arm

Active Comparator group

Description:

Patients in the control arm received the investigator's choice of one of the following three regimens: 1. FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. 2. a high-dose cytosine arabinoside-based regimen; 3. a high-dose methotrexate-based regimen

Treatment:

Drug: Fludarabine