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A clinical study of mitoxantrone liposome, chidamide combined with lenalidomide in the treatment of angioimmunoblastic T-cell lymphoma (AITL)

A clinical study of mitoxantrone liposome, chidamide combined with lenalidomide in the treatment of angioimmunoblastic T-cell lymphoma (AITL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099653
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Angioimmunoblastic T-cell lymphoma (AITL)

Interventions

Experimental group:Mitoxantrone liposome16-20mg/m^2,iv,d1
Cediranib 20mg~30mg,po,biw
Lenalidomide 10mg,po(the dosage is determined by the investigator based on the patients tolerance, either 1-14 days or 1-21 days of administration).

Sponsors

THE FIRST HOSPITAL OF LANZHOU UNVERSITY
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient fully understands this study and voluntarily participates in it. 2. Age: >= 18 years old. 3. The expected survival time is >= 3 months. 4. Angioimmunoblastic T-cell lymphoma (AITL) diagnosed by histopathology. 5. Patients with newly diagnosed cases or relapsed patients who have received at least one line of systemic treatment with an anthracycline-containing regimen in the past. Relapsed and refractory is defined as relapse after complete remission (CR), or failure to achieve partial remission after 2 cycles of initial chemotherapy, and failure to achieve complete remission after 6 cycles of chemotherapy. 6. There must be at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: for lymph node lesions, the measurable lymph nodes should have a long diameter > 1.5 cm; for non-lymph node lesions, the measurable extranodal lesions should have a long diameter > 1.0 cm. 7. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2 points. 8. Hepatic and renal functions: Serum creatinine <= 1.5 times the upper limit of the normal value; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 times the upper limit of the normal value (<= 5 times the upper limit of the normal value for patients with liver invasion); Total bilirubin <= 1.5 times the upper limit of the normal value (<= 3 times the upper limit of the normal value for patients with liver invasion).

Exclusion criteria

Exclusion criteria: 1. Uncontrollable systemic diseases, that is, even after drug treatment, the control still fails to meet the standard, and the indicators are still higher than the normal ones in the disease field (such as cardiovascular diseases, diabetes, etc.); 2. A history of known immediate or delayed hypersensitivity reactions to drugs of the same class as the study drug and its excipient components; 3. Patients who refuse to adopt effective contraceptive measures during the study period; 4. Patients who are simultaneously participating in other interventional clinical studies; 5. Patients with other concurrent malignant tumors that require treatment; 6. Patients whom the investigator deems inappropriate to participate in this study; 7. Patients who have previously used this treatment regimen and showed no response to the clinical treatment.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
CRR;mPFS;mOS;Safety;

Countries

China

Contacts

Public ContactZIjian Li

THE FIRST HOSPITAL OF LANZHOU UNVERSITY

zijianli@foxmail.com+86 189 9311 5461

Outcome results

None listed

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