Relapsed/Refractory Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Study of PD-1 Monoclonal Antibody in Combination With Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence rate of about 4%. Non-Hodgkin's lymphoma (NHL) is highly heterogeneous and can be broadly divided into two major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of different pathological types and malignant degrees, and the prognosis is not the same.The anti-PD-1 antibody may benefit patients with relapsed or refractory Hodgkin's lymphoma. At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic prospects. We propose this research program, based on the previous research at home and abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and safety, and explore The best treatment strategy for patients with relapsed and refractory NHL in China.
Lymphoma is one of the fastest growing malignancies in the world, with an annual incidence
rate of about 4%. In recent years, the incidence of malignant lymphoma in China has increased
rapidly. It has risen to the ninth place among the top ten high-incidence tumors in men, and
the female has risen to the eleventh place. In 2011, the incidence of lymphoma in the country
has reached 6.43/100,000.
According to the characteristics of clinicopathology, lymphoma is divided into two
categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). HL is a single disease,
relatively rare, but the prognosis is good, and patients with limited period have no progress
for 5 years. The survival rate was 85-95%, and the 5-year progression-free survival rate of
advanced patients was 30-85%. NHL is highly heterogeneous and can be broadly divided into two
major categories, B-cell lymphoma and T/NK cell lymphoma. It is composed of diseases of
different pathological types and malignant degrees, and the prognosis is not the same.
In recent years, immunological checkpoint inhibitors have been the focus of research in the
field of malignant tumor treatment. In clinical trials, PD-1/PD-L1 was found to be abnormally
expressed in various lymphomas, including T-cell lymphoma, mediastinal large B-cell lymphoma,
classical Hodgkin's lymphoma (CHL), and large variability. Cell lymphoma. Previous studies
have evaluated the effects of antibody-based drugs against PD-1 (such as navobizumab and
pabuleizumab) in patients with relapsed or refractory classic Hodgkin's lymphoma, and A
higher response rate is shown and the security feature is acceptable. The domestic ORIENT-1
study showed that ididilimumab was highly active in patients with relapsed or refractory
classic Hodgkin's lymphoma in China, and 80% (74/92) patients had an objective response. No
patients died during the study. Of the 96 patients treated, 89 (93%) had treatment-related
adverse events, including 17 (18%) patients with grade 3 or 4 treatment-related adverse
events, and 11 patients (11%) experienced severe Adverse events, but no unexpected or
off-target safety signals were found. Therefore, PD1 antibodies may benefit patients with
relapsed or refractory Hodgkin's lymphoma.
At the same time, in non-Hodgkin's lymphoma, PD1 antibodies also show promising therapeutic
prospects. Clinical studies at home and abroad have shown that PD-1 inhibitors are effective
in relapsed or refractory extranodal NKT lymphoma. The results of the Idiliumab ORIENT-4 test
showed that 1 year OS 82.1%, ORR 67.9%, DCR 85.7%, and PD-1 inhibitor combined with citabin
to treat relapsed or refractory extranodal NKT is underway; PD-1 inhibitor monotherapy for
relapsed or refractory PTCL is generally effective (ORR 33%, 4 of them CR); PD-1 inhibitor
monotherapy is effective in treating relapsed or refractory mycosis/Sezary syndrome (ORR)
37.5%) has been recommended by the NCCN guidelines; trials in combination with IFN γ-1b are
underway. PD-1 inhibitor monotherapy for relapsed or refractory PMBCL or PCNSL is effective,
and PD-1 inhibitors have been recommended by the NCCN guidelines for the former treatment.
Therefore, we propose this research program, based on the previous research at home and
abroad, to further clarify the role of PD-1 monoclonal antibody combined with chemotherapy in
the treatment of relapsed and refractory NHL patients, evaluate its clinical efficacy and
safety, and explore The best treatment strategy for patients with relapsed and refractory NHL
in China.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02095574 -
A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma
|
Phase 1 |