Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

NCT05958719 | Recruiting Phase 2

• 1 other identifier: IIT2023003
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.

Conditions

Peripheral T Cell Lymphoma; Epigenetic Repression

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.

  2 years post initiation of treatment

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  2 years post initiation of treatment

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  2 years post initiation of treatment

• Duration of Response (DOR)

  2 years post initiation of treatment

• Overall Survival (OS)

  2 years post initiation of treatment

Other Outcomes (2)

• levels of lymphocyte subsets in blood

  2 years post initiation of treatment

• levels of cytokines in serum

  2 years post initiation of treatment

Study Arms (2)

interim evaluation of CR group

EXPERIMENTAL

Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another two cycles with CAMP regimen can be obtained. Subsequently,chidamide monotherapy was given as maintenance therapy for 24 months. Patients with interim evaluation of SD or PD withdrew from this study.

Drug: Chidamide; Drug: Azacitidine; Drug: liposomal mitoxantrone; Drug: prednisone

interim evaluation of PR group

EXPERIMENTAL

Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated withchidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for four cycles. For patients with interim-PET evaluation of PR, another two cycles of CAMP regimen will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT and following chidamide maintenance. Subsequently, chidamide monotherapy was given as maintenance therapy for 24 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study.

Drug: Chidamide; Drug: Azacitidine; Drug: liposomal mitoxantrone; Drug: prednisone

Interventions

Chidamide DRUG

chidamide 30mg biw, p.o, 21 days for a cycle.

interim evaluation of CR group; interim evaluation of PR group

Azacitidine DRUG

75mg/m2, continuous i.h. on day 1-7，21 days for a cycle.

interim evaluation of CR group; interim evaluation of PR group

liposomal mitoxantrone DRUG

12mg/m2， d1,21 days for a cycle.

interim evaluation of CR group; interim evaluation of PR group

prednisone DRUG

60mg/m2，d1-5,21 days for a cycle.

interim evaluation of CR group; interim evaluation of PR group

Eligibility Criteria

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

You may qualify if:

• Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
• More than 18 years of age.
• Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10\^9/L); 2) platelet count (≥75×10\^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min;
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• LVEF value measured by echocardiography ≥50%.
• Life expectancy \> 3 months.

You may not qualify if:

• Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
• Patients with central nervous system involvement by lymphoma.
• Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
• Pregnant or breastfeeding women.
• Presence of human immunodeficiency virus (HIV) virus infection.
• Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded:
• Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;
• Carcinoma in situ of the cervix

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

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

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dehui Zou, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dehui Zou, Dr.

CONTACT

86-022-23909282; zoudehui@ihcams.ac.cn

Huimin Liu, Dr.

CONTACT

86-022-23909282; liuhuimin@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of lymphoma Diagnosis and Treatment Center

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 25, 2023
• Study Start: March 2, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 2, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)