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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Angioimmunoblastic T-cell Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03853044

C-CHOP

Details and patient eligibility

About

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.

Full description

This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Has accepted Chemotherapy before
2. Has accepted autologous Stem cell transplantation before
3. 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
4. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
5. Primary CNS lymphoma
6. LVEF≤50%
7. 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
8. Other uncontrollable medical condition that may that may interfere the participation of the study
9. Not able to comply to the protocol for mental or other unknown reasons
10. Pregnant or lactation
11. HIV infection
12. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Chidamide plus CHOP

Experimental group

Description:

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

Treatment:

Drug: Chidamide

Drug: Vincristine

Drug: Cyclophosphamide

Drug: Prednisone

Drug: Doxorubicin