diffuse large B cell lymphoma
Conditions
Interventions
Phase I dose escalation group:Pomalidomide combined with R-ICE
Phase II group:Pomalidomide combined with R-ICE
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed diffuse large B cell lymphoma (primary mediastinal large B-cell lymphoma, primary central lymphoma and HIV related lymphoma are excluded) according to World Health Organization (WHO) classification; 2.Evaluable disease by PET or CT; 3.Life expectancy over 3 months; 4.Prior treatment with sufficient first-line anti-lymphoma therapy, no remission or disease progression within 90 days of last administration, and no current anti-lymphoma therapy (>=2 weeks since last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons; 5.Aged 18 to 75 years, male or female; 6.ECOG 0-2 score; 7.No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : (1)Absolute value of neutrophil count >=1500/mm^3; Platelet count >=75,000/mm^3; (2)Total bilirubin =60ml/min; (5)There is no cardiac insufficiency. 8.If subject of childbearing age is required to use effective contraception, subject agrees to comply with all contraceptive requirements: (1)There are fertile women must decide, at the same time take two reliable contraceptive methods (a kind of high efficient contraceptives - tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needle, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method -- men or synthetic rubber condom, diaphragm or cervical cap); (2)Unless hysterectomy is performed, effective contraception is required even if there is a history of infertility. 9.Fertile men must always use rubber or synthetic condoms when having sexual contact with fertile women during the use of this product and within 28 days of discontinuing this product, even if they have successfully had a vasectomy; 10.The subject understands the characteristics of the disease and voluntarily joins the study for treatment and follow-up, and the informed consent is signed by the subject himself or his guardian and an impartial witness.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking pomalidomide); 2.Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA> detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons; 3.Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 4.Bone marrow failure, defined as ANC=5 years prior to enrollment; (2)Basal cell carcinoma of the skin (except melanoma) that has received adequate treatment and has no signs of disease; (3)Carcinoma in situ of the cervix without signs of disease after adequate treatment. 11.Severe cases; 12.Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; 13.Patients considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactZhao Weili
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed