Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
NCT ID: NCT03853044
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
23 participants
INTERVENTIONAL
2018-12-29
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chidamide plus CHOP
Participants received six 21-day cycles of chidamide, combined with six cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (21-day cycles).
Chidamide
Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Prednisone
Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Interventions
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Chidamide
Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Prednisone
Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director
Principal Investigators
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Weili Zhao, MD. PhD
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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Ruijin hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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C-CHOP
Identifier Type: -
Identifier Source: org_study_id
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