NCT06176027

Brief Summary

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
52mo left

Started Oct 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2024Sep 2030

First Submitted

Initial submission to the registry

August 5, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

3.9 years

First QC Date

August 5, 2023

Last Update Submit

October 26, 2024

Conditions

Relapsed Peripheral T-Cell LymphomasRefractory Peripheral T-Cell Lymphomas

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    ORR was defined as the proportion of patients who achieved CR or PR as their best response

    1 year

Secondary Outcomes (2)

  • Overall Survival (OS)

    through study completion, an average of 2 year

  • Progression Free Survival (PFS)

    18 months

Study Arms (1)

Azacytidine plus CAOLD regimen

EXPERIMENTAL

Patients were treated by Azacytidine plus CAOLD regimen

Drug: Azacytidine plus CAOLD regimen

Interventions

Azacytidine plus CAOLD regimenDRUG

Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)

Azacytidine plus CAOLD regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must satisfy all following criteria to be enrolled in the study:
  • Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
  • Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
  • Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
  • Meet the following lab criteria:
  • Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)
  • Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)
  • Hemoglobin ≥ 8 g/dL.
  • Anticipated life expectancy at least 3 months

You may not qualify if:

  • Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
  • Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Liren Qian, PhD

    Navy General Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

Liren Qian, PhD

CONTACT

+861066957676qlr2007@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician, Associate Professor

Study Record Dates

First Submitted

August 5, 2023

First Posted

December 19, 2023

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2030

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

CN(1)