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Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL

NCT06224842 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-25

No results posted yet for this study

Summary

This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m\^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m\^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.

Conditions

  • Angioimmunoblastic T-cell Lymphoma

Interventions

DRUG

mitoxantrone liposome 16 and azacitidine

The mitoxantrone liposome will be intravenous infused at a dose of 16mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).

DRUG

mitoxantrone liposome 18 and azacitidine

The mitoxantrone liposome will be intravenous infused at a dose of 18mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).

DRUG

mitoxantrone liposome 20 and azacitidine

The mitoxantrone liposome will be intravenous infused at a dose of 20mg/m\^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days).

Sponsors & Collaborators

  • Beijing Xisike Clinical Oncology Research Foundation

    collaborator UNKNOWN

  • CSPC Pharmaceutical Group

    collaborator UNKNOWN

  • Huijing Wu

    lead OTHER

Principal Investigators

  • Huijing Wu · Hubei Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224842 on ClinicalTrials.gov