A prospective, single armed, phase II clinical trial for the combination of crizotinib and salvage chemotherapy in patients with relapsed or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)

Combination of crizotinib and salvage chemotherapy in patients with relapsed or refractory anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029373

Enrollment

Unknown

Registered

2020-01-26

Start date

2013-01-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

Lymphoma

Interventions

Case series:crizotinib and salvage chemotherapy

Eligibility

Sex/Gender

All

Age

7 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. informed consent obtained; 2. patients younger than 75 years old; 3. Patients with life expectancy at least 12 weeks; 4. Patients had an Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 2; 5. patients had histologically confirmed sALCL with ALK expression identified using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) assays in the Pathology Department of Sun Yat-sen Cancer Center; 6. They had not received previous cytotoxic chemotherapy within two weeks before enrollment and had recovered from the acute toxic effects of previous therapy before initiation of crizotinib or salvage chemotherapy; 7. At least one lesion with > 15 mm long axis, or 18FDG-PET/CT-avid; 8. Patients had adequate bone marrow (absolute neutrophil count >=1000 cells per uL, platelet count >=50 000 cells per uL), renal <=1.5 ULN serum creatinine, and hepatic (total bilirubin <=1.5 ULN and alanine aminotransferase <=2.5 ULN) function; 9. Voluntarily provided to follow the visit plans; 10. All patients of childbearing age must agree to effective contraception during the study period and within 6 months of discontinuation of treatment. Female patients of childbearing age must have a negative urine pregnancy test before treatment.

Exclusion criteria

Exclusion criteria: 1. Transforming lymphoma; 2. Received treatment for lymphoma within 2 weeks before enrollment; 3. History of other malignancies; secondary lymphoma, lymphosarcoma, and leukemia occurring after chemotherapy or radiotherapy for other malignancies; central lymphoma involvement; 4. Neutrophil count <1.0x10^9/L, or hemoglobin <80g / L, or platelet count <90x10^9/L; liver dysfunction unrelated to lymphoma (transaminases exceed 3 times the upper limit of normal and / or blood Bilirubin greater than 2.0 mg/dl); Renal insufficiency (blood creatinine concentration more than twice the upper limit of normal value) unrelated to lymphoma; 5. active infections, decompensated heart failure, dilated cardiomyopathy that require systemic antibiotics or antiviral drugs, coronary heart disease with ST segment depression on the electrocardiogram, and myocardial infarction that has occurred in the last 6 months Patients with severe organic disease, severe mental illness; 6. Allergic to any research drug; 7. Pregnant women or breast-feeding women; 8. Patients who have been administered any other investigational product within the 3 weeks prior to first dose of investigational product in the study.

Design outcomes

Primary

Measure	Time frame
Objective remission ratio;	—

Countries

China

Contacts

Public ContactTong-yu Lin

Sun Yat-sen University Cancer Center

linty@sysucc.org.cn+86 13926400320

Outcome results

None listed

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