A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and...
LymphomaT-cell4 moreThe primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).
The Whole-course Management of Pegaspargase in ENKTL
Extranodal NK/T Cell LymphomaThis is a prospective, multi-center study of the whole-course management of pegaspargase in Extranodal NK/T cell lymphoma (ENKTL). Based on a complete population pharmacokinetic model of pegaspargase in ENKTL patients, the time node of asparaginase monitoring and the principle of dose adjustment will be formulated. Besides, the proportion of "silent inactivation" of asparaginase in ENKTL patients and its effect on the prognosis of patients will also be explored. The treatment plan is as follows: (1) During 8 early (stage I/II) ENKTL patients receiving P-GOD (peasparaginase + gemcitabine + oxaliplatin + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (2) During 4 early (stage III/IV) ENKTL patients receiving PEMD (peaspargase + etocytidine + methotrexate + dexamethasone) for the first time, the activity of pegaspargase in peripheral blood will be detected on D3, D4, D5, D6, D7, D8, D10, D12, D14, D16, D18 and D21. (3) During 72 (including above 12 patients) ENKTL patients receiving P-GOD/PEMD, the activity of pegaspargase and anti-pegaspargase in peripheral blood will be detected on D9 and D16 of each cycle of treatment.
Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With...
Epidermotropic T-cell LymphomasEpidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis...
Cutaneous T-Cell Lymphoma/Mycosis FungoidesThe main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries. Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects. Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.
Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T...
Extranodal NK/T Cell LymphomaNasal TypeThe purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
Extranodal NK/T-cell LymphomaNasal TypeThe purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.
An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin...
Hodgkin's LymphomaMature T-cell Lymphoma1 moreThe study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients with myeloma) will have an acceptable toxicity profile and that in combination will have sufficient activity in the target population (including those previously refractory to HDACi monotherapy) to warrant further investigation.
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma...
Cutaneous T-cell Lymphoma (CTCL)This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).
Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma...
Peripheral T-cell LymphomaRevlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.
Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma...
LymphomaPrimary Objectives: To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL. Secondary Objectives: To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib. Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.