Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

NCT03853044 | Unknown Phase 2

• 1 other identifier: C-CHOP
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.

Conditions

Angioimmunoblastic T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

  At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (6)

• Overall response rate

  At the end of Cycle 6 (each cycle is 21 days)

• Progression free survival

  Baseline up to data cut-off (up to approximately 4 years)

• Overall survival

  Baseline up to data cut-off (up to approximately 4 years)

• Duration of response

  Baseline up to data cut-off (up to approximately 4 years)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Baseline up to data cut-off (up to approximately 4 years)

Other Outcomes (1)

• Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

  Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

Chidamide plus CHOP

EXPERIMENTAL

Participants received six 21-day cycles of chidamide, combined with six cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (21-day cycles).

Drug: Chidamide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Chidamide DRUG

Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles

Chidamide plus CHOP

Cyclophosphamide DRUG

Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.

Chidamide plus CHOP

Doxorubicin DRUG

Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.

Chidamide plus CHOP

Vincristine DRUG

Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.

Chidamide plus CHOP

Prednisone DRUG

Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Chidamide plus CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed angioimmunoblastic T cell lymphoma
• Treatment naive
• Age \> 18 years
• Must has measurable lesion in CT or PET-CT prior to treatment
• ECOG 0,1,2
• Informed consented

You may not qualify if:

• Has accepted Chemotherapy before
• Has accepted autologous Stem cell transplantation before
• History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
• Primary CNS lymphoma
• LVEF≤50%
• Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<75\*10\^9/L; ALT or AST \>2\*ULN; AKP or bilirubin \>1.5\*ULN ;Creatinine\>1.5\*ULN
• Other uncontrollable medical condition that may that may interfere the participation of the study
• Not able to comply to the protocol for mental or other unknown reasons
• Pregnant or lactation
• HIV infection
• If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Immunoblastic Lymphadenopathy

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphadenopathy; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Weili Zhao, MD. PhD

  Ruijin Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: December 29, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)