Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Pancytopenia Due to Chemotherapy

Treatments: Drug: rhIL-11

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02314273

TBK-10-01

Details and patient eligibility

About

The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.

Full description

Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group

Enrollment: 120 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• new diagnosis of ALL
• TBIL≤34umol/L，Cr≤120umol/L，a normal EF
• age <18 years

Exclusion criteria

• patients with uncontrolled infection
• patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

rhIL-11 group

Experimental group

Description:

patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL

Treatment:

Drug: rhIL-11

control group

No Intervention group

Description:

control group