A Phase II, Multi-Center, Investigator-Initiated Study of Dasatinib against Angioimmunoblastic T-Cell Lymphoma (AITL) and Other T Follicular Helper Cell Lymphoma - AI-Help

Chiba Shigeru0 sites18 target enrollmentAugust 20, 2019

ConditionsRelapsed/refractory T Follicular Helper Cell Lymphoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Relapsed/refractory T Follicular Helper Cell Lymphoma
Sponsor: Chiba Shigeru
Enrollment: 18
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 20, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Chiba Shigeru

Eligibility Criteria

Inclusion Criteria

•(1\)Diagnosed as having angioimmunoblastic T\-cell lymphoma (AITL), follicular T\-cell lymphoma (FTCL), nodal T\-cell lymphomas with T\-follicular helper cell phenotype (nPTCL\-TFH) or peripheral T\-cell lymphoma not otherwise specified (PTCL\-NOS) by histopathological evaluation by biopsy at each investigational sites. (2\)Correspond to one or more of the following. AITL in the preceding paragraph is not limited to this. A. Immunohistochemical test of biopsy samples (two or more of PD1, ICOS, CXCL13, BCL6, CXCR5 are positive for tumor cells.) B. Immunohistochemical test or flow cytometry of a biopsy sample confirmed positive for tumor cells CD10\. C. The DNA of the biopsy sample has been confirmed to be positive for the G17V mutation of the RHOA gene. Relapse after at least 1 regimen of chemotherapy to target diseases before enrollment, or SD or PD with the latest regimen. (3\)One or more lesions other than skin that can be measured in two directions orthogonal to each other in a CT tomographic image. The size of the lesion should be 1\.5 cm or more for nodular lesions and 1\.0 cm or more for extranodal lesions. (4\)Relapse after at least 1 regimen of chemotherapy to target diseases before enrollment, or SD or PD with the latest regimen (5\)Able to provide with tumor tissue samples (FFPE) at the initial or relapsed time (6\)Males and females aged 20 years or older (at the time of obtaining consent) (7\)Performance status (PS) of 0 to 2 according to the ECOG criteria (8\)Organ functions maintained that meet the following criteria. A. WBC \>\= 2,000 /microliter B. Neutrophils \>\= 1,000 /microliter C. Platelets \>\= 75,000 /microliter D. Hemoglobin \>\= 8\.0 g/dL E. SpO2 \>\= 95% (9\)Having given the patient s written consent to participation in the study

Exclusion Criteria

•(1\)Patients with clinical findings of central nervous system (CNS) invasion attributable to lymphoma. Neurological evaluation and head CT/MRI and lumbar puncture should be performed for patients with suspected CNS invasion in order to exclude CNS lesions. (2\)Patients with poor\-controlled systemic fungal, bacterial, or viral infection (unresolved and persistent infection\-related signs/symptoms despite appropriate antibiotics, antiviral therapies, and/or other therapies) (3\)Patients infected with human immunodeficiency virus (HIV), Human T\-lymphotropic virus type\-1 (HTLV\-1\) or hepatitis C virus (HCV), or those who have findings of active hepatitis B virus (HBV) infection shown below (HBsAg\-positive, HBsAg\-negative, with anti\-HBs antibody\-positive and/or anti\-HBc antibody\-positive and viral DNA detectable) (4\)Renal function disorder (creatinine clearance calculated by the Cockcroft\-Gault formula, \<30 mL/min) or hepatic function disorder \[total serum bilirubin level, \>2\.0 mg/dL (34 micromol/L) (except the case of Gilbert symptoms or identified invasion of lymphoma into the liver or pancreas), serum transaminase (AST or ALT), \>3 times of the upper limit of normal level (except the case associated with lymphoma)] (5\)Patients with a medical history of malignant tumor other than diseases targeted in this study and/or a histry of radiation therapy. However, patients who underwent surgery for radical cure and have shown no signs of relapse for 5 years can be included. Patients with the following medical history/complications can be included. (basal or squamous cell carcinoma of the skin, intraepithelial carcinoma of uterine cervix, intraepithelial carcinoma of breast, Accidental histological findings of prostate cancer using tumor, nodes, and metastasis (TNM) clinical staging system (T1a or T1b), Early gastric cancer for which endoscopic mucosal resection or endoscopic submucosal dissection was performed)
•(6\)Patients who are using any other study drugs, whatever types they may be, at the start of administration of the drugs for this study, or have used other study drugs within 4 weeks. Patients who continuously have medically\-critical adverse events because of the pretreatment, regardless of its duration. (7\)Patients who received or will receive prior treatment corresponding to the following 1\) to 3\) by the start of administration of the drug for this study. 1\) Blood transfusion, albumin preparation, G\-CSF: within 1 week 2\) Patients who are receiving any systemic steroids for antitumor effects (except continuous administration of low\-dose steroids, for example, a dose of 10 mg/day in terms of prednisolone, to the primary disease since before obtaining consent) or chemotherapy (within 4 weeks) 3\) Antibody therapy for anti\-tumor effect: within 12 weeks (8\)Patients who have or are suspected to have hypersensitivity to active ingredients or other ingredients of the study drug (9\)Women who are pregnant, planning to be pregnant, or breastfeeding Women of childbearing potential are excluded if they do not agree to follow instructions on contraception during a period from the start of the study until the end of study drug administration plus 31 days, consisting of an ovulation cycle of 30 days and additional 25 hours (1 day) which is a period 5 times as long as the elimination half\-life of the study drug (3 to 5 hours). Furthermore, men that have a female partner of childbearing potential are excluded if they do not agree to follow instructions on contr