Refractory Peripheral T-Cell Lymphoma, Relapsed Peripheral T-Cell Lymphoma
Conditions
Keywords
Allogeneic hematopoietic stem cell transplantation, Pralatrexate, Remission status before transplantation
Brief summary
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
Interventions
OTHERPralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week. 4. After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.
Sponsors
Ruijin Hospital
Wuhan TongJi Hospital
West China Hospital
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients fully understand the study, voluntarily participate in and sign on the informed consent; * Diagnosed by histopathology Peripheral T-cell lymphoma; * ECOG PS score 0 or 1; * Relapsed or Refractory Peripheral T Cell Lymphoma； * According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter\>1.5cm; measurable extranodal lesion diameter\>1.0cm)； * Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory; * Expected survival at least 12 weeks； * Agreed to receive treatment with Pralatrexate
Exclusion criteria
* NK/T-cell lymphoma; * Achieving CR or PR after induction chemotherapies without relapse; * Dysfunction of vital organs; * Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation; * Unwilling to accept allogeneic hematopoietic stem cell transplantation; * Undergoing other clinical studies within a month; * Without donor for transplantation; * Allergies to similar drugs and excipients of the research drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) at 1 year after transplantation | Participants will be followed for an expected average of 1 years after transplantation | The time from the end of transplantation to progression of disease or death at 1year |
Countries
China
Contacts
Primary ContactXiaodong Mo, MD
Backup ContactXiaodong Mo, MD
Outcome results
None listed