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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    23
  • sponsor
    Ruijin Hospital
Updated on 23 January 2021
cyclophosphamide
lymphoma
vincristine
prednisone
measurable disease
doxorubicin
t-cell lymphoma

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.

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.

Details
Condition Angioimmunoblastic Lymphadenopathy
Treatment cyclophosphamide, prednisone, vincristine, doxorubicin, Chidamide
Clinical Study IdentifierNCT03853044
SponsorRuijin Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Angioimmunoblastic Lymphadenopathy?
Do you have any of these conditions: Do you have Angioimmunoblastic Lymphadenopathy??
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

Exclusion Criteria

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
LVEF50%
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>1.5ULN
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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