Peripheral T-cell Lymphoma Clinical Trial
Official title:
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: - age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score=3;expected survival=3 months - patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC); - acceptable hematological indicators, no chemotherapy contraindications; - total bilirubin = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) = 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group; - At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-Computed Tomography); - exclude other major diseases, normal heart and lung function; - Female patients of childbearing age are negative for pregnancy test; - Cooperate with follow-up; - There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms); - Signing informed consent *: Pathological histology must be consulted by a pathologist at a provincial hospital. Exclusion Criteria: - Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma - rejecting providing blood preparation; - allergic to drug in this study and with metabolic block; - rejecting adopting reliable contraceptive method in pregnancy or lactation period; - uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas); - with severe infection; - with primary or secondary central nervous system tumor invasion; - with immunotherapy or radiotherapy contraindication; - ever suffered with malignant tumor; - having peripheral nervous system disorder or dysphrenia; - with no legal capacity,medical or ethical reasons affecting research proceeding; - participating other clinical trials simultaneously; - adopting other anti-tumor medicine excluding this research; - Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients - Human immunodeficiency virus (HIV)-positive patients - the researchers considering it inappropriate to participate in the study. - Patients with immune system diseases |
Country | Name | City | State |
---|---|---|---|
China | Oncology Department of The First Affilliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Mingzhi Zhang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation. | From date of randomization until the date tumor volume has reduced, assessed up to 36 months | |
Primary | Progression-free Survival | The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | |
Primary | Overall Survival | Time from randomization to death for any reason | From date of randomization until date of death from any cause, assessed up to 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00038025 -
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
|
Phase 2 | |
Recruiting |
NCT02445404 -
Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
|
Phase 2 | |
Completed |
NCT02168140 -
CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1 | |
Completed |
NCT01689220 -
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
|
Phase 1 | |
Terminated |
NCT01644253 -
Phase 1b Safety and Efficacy Study of TRU-016
|
Phase 1 | |
Completed |
NCT01435863 -
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
|
Phase 1 | |
Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
Terminated |
NCT00441025 -
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
|
Phase 2 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
Active, not recruiting |
NCT04312841 -
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
|
Phase 2 | |
Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
Completed |
NCT02264613 -
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
|
Phase 1/Phase 2 | |
Completed |
NCT02142530 -
Carfilzomib Plus Belinostat in Relapsed/Refractory NHL
|
Phase 1 | |
Terminated |
NCT01408043 -
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
|
N/A | |
Completed |
NCT00131937 -
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT00791947 -
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT
|
Phase 2 | |
Recruiting |
NCT04880746 -
Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
|
Phase 3 | |
Recruiting |
NCT03964480 -
Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.
|