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A randomized controlled trial for arsenic trioxide combined with ESHAP (etoposide+methylprednisolone+cytarabine+cisplatin) in the treatment of relapsed or refractory ALK+ anaplastic large cell lymphoma.

A randomized controlled trial for arsenic trioxide combined with ESHAP (etoposide+methylprednisolone+cytarabine+cisplatin) in the treatment of relapsed or refractory ALK+ anaplastic large cell lymphoma.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017310
Enrollment
Unknown
Registered
2018-07-23
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALK+ anaplastic large cell lymphoma

Interventions

Control group:Etoposide 60mg/m2/d d1-4
Methylprednisolone 500mg/d d1-4
Cytarabine 2g/m2/Q12h d5
Cisplatin 25mg/m2/d d1-4
Experimental group:Etoposide 60mg/m2/d d1-4
ATO 10mg/d d1-14

Sponsors

Tongji Hospital Affiliated to Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years; 2. Diagnosed with histologically confirmed ALK positive anaplastic large lymphoma (WHO classification(2016)); 3. Didn't reach CR or relapsed following first-line treatment; 4. Measurable disease with baseline positron emission tomography (PET) scans demonstrating positive lesions compatible with anatomical tumour sites identified by computerized tomography (CT); 5. Patients were required to have an Eastern Cooperative Oncology Group performance status of 0-2.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing women; 2. Human infected immunodeficiency virus,active hepatitis B or C; 3. Presence of central nervous involvement; 4. History of myocardial infarction within the past 6 months; 5. Any significant concurrent,uncontrolled medical condition; 6. Total bilirubin >2x upper limit of normal (ULN),and/or alkaline phosphatase or aspartate aminotrnaferase >2.5x ULN unless there was evidence of direct liver involvemet by lymphoma; 7. Creatinine >1.5x ULN; 8. Any other tumour.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
CR;PR;OS;PFS;AE;

Countries

China

Contacts

Public ContactDing Yi

Tongji Hospital Affiliated to Tongji University School of Medicine

18621908870@163.com+86 18621908870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026