- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176027
Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Angioimmunoblastic T Cell Lymphoma
January 28, 2024 updated by: Liren Qian, Navy General Hospital, Beijing
Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma
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 angioimmunoblastic T-cell lymphoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory angioimmunoblastic T-cell lymphoma.
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liren Qian, PhD
- Phone Number: +861066957676
- Email: qlr2007@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100048
- Recruiting
- Navy General Hospital
-
Contact:
- Liren Qian, M.D.
- Phone Number: +861066957676
- Email: qlr2007@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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;
- Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.)
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Azacytidine plus CAOLD regimen
Patients were treated by Azacytidine plus CAOLD regimen
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 1 year
|
ORR was defined as the proportion of patients who achieved CR or PR as their best response
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: through study completion, an average of 2 year
|
OS was defined as time from diagnosis to death from any cause or the last follow-up
|
through study completion, an average of 2 year
|
Progression Free Survival (PFS)
Time Frame: 18 months
|
PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Liren Qian, PhD, Navy General Hospital, Beijing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2030
Study Registration Dates
First Submitted
August 5, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Actual)
December 19, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphadenopathy
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Immunoblastic Lymphadenopathy
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Azacitidine
Other Study ID Numbers
- NavyGHB-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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