"Wan" is in the spotlight, "moving" road follows, domestic melphalon helps China's transplant field to flourish - Wanjia ® melphalon hydrochloride hydrochloride cloud summit forum for injection was successfully held!

After the opening ceremony, the academic session followed closely and began
in full swing.
The first session was chaired by Professor Hou Jian from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine and Professor Liu Peng from Zhongshan Hospital affiliated to Fudan University
.
Professor Fu Chengcheng of the First Affiliated Hospital of Soochow University introduced the topic of "Clinical Application of Wanjia ^® (Mephalan Hydrochloride for Injection) in Pretreatment of Hematopoietic Stem Cell Transplantation
".
Professor Fu first introduced the marketing process of Mephalan hydrochloride hydrochloride for Wanjia, and pointed out that its imitation was Alkeran's injection dosage form (lyophilized powder for injection, 50mg), and formulated the indications and dosage of Wanjia ^{® ®} with reference to Alkeran's^®® approval in the United States and Japan
。 Subsequently, Professor Fu mentioned in combination with guideline recommendations and clinical studies that melphalan 200mg/^m2 is the standard pretreatment regimen for MM patients, which is safe and effective in the pretreatment of lymphoma, adult leukemia and childhood leukemia ASCT and/or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Treatment regimens combined with melphalan are also well
used in neuroblastoma and retinoblastoma.
Finally, Professor Fu introduced that the two forms of melphalan for injection include the original Alkeran^® as the representative, the excipient is povidone, containing a special solvent, and Evomela^®, the excipient is cyclodextrin derivative (sodium salt of β-cyclodextrin sulfobutyl ether), which does not contain a special solvent
.
Wanjia, the former is the first approved imitation, the safety and effectiveness are consistent with Alkeran, and the approved scope of application is wider than that of mephalan represented by Evomela ^®®
.
^®

Professor Fu Chengcheng gave a report

The second session was chaired by Professor Wang Xiaopei of Peking University Cancer Hospital, and Professor Liu Weiping of Peking University Cancer Hospital gave a report on the current situation and prospect of autologous hematopoietic stem cell transplantation in China from three aspects: national ASCT overview, lymphoma and MM ASCT overview in 2021
。 The report collected a total of 5221 cases of ASCT reported in 211 centers in 29 provinces and cities in China in 2021, and a total of 4556 cases of ASCT for the first time in lymphoma and myeloma, of which the ASCT utilization rate of lymphoma was 2.
4% and the utilization rate of myeloma ASCT was 11.
3%.

In terms of lymphoma pretreatment, the utilization rate of BEAM regimen is 59%, and a more unified pretreatment option
has not been formed.
In terms of myeloma pretreatment, melphalan monotherapy rate accounted for 87%, and the rest of the regimens were mostly based
on melphalan.
A series of multicenter retrospective and prospective studies in China have found that ASCT has brought good survival benefits to patients with mantle cell lymphoma, peripheral T-cell lymphoma and T lymphoblastic lymphoma.
On the whole, the degree of ASCT development in China is insufficient, and high-level evidence-based medical evidence is lacking, and it is urgent to train professional personnel and teams to carry out more high-quality clinical studies
suitable for Chinese patients.

*BEAM protocol: carmustine + etoposide + cytarabine + melphalan

Professor Liu Weiping gave a report

The third session was chaired by Professor Chen Wenming of Beijing Chaoyang Hospital affiliated to Capital Medical University, and Professor Li Xin of the Third Xiangya Hospital of Central South University gave a speech entitled "Autologous hematopoietic stem cell transplantation for the treatment of newly diagnosed multiple myeloma", from the status of newly diagnosed MM (NDMM) patients transplantation, The practice of ASCT in his center, as well as the three aspects of hematopoietic reconstitution and immune reconstitution after ASCT, were interpreted
in detail.
In the era of new drugs, ASCT is still an important treatment for MM, and domestic and foreign guidelines recommend ASCT as the first-line treatment
for NDMM.
For MM patients in China, ASCT is a treatment with higher valence
.
In the MM diagnosis and treatment path of the Third Xiangya Hospital of Central South University, the pretreatment scheme of ASCT is based on mephalon, and the classic pretreatment scheme is high-dose melphalan (200mg/m²), but the dose of melphalan can be appropriately increased or decreased
with different risk degrees and extramedullary MM.
Post-transplantation hematopoietic reconstruction is related to the number of CD34+ cells, previously used drugs, pretreatment, etc.
, and post-transplantation immune reconstitution is closely related
to prognosis.

Professor Li Xin gave a report

The fourth session was chaired by Professor Xia Linghui of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, and Professor Wang Sanbin of the 920th Hospital of the PLA Joint Logistics Support Force introduced the application
of melphalan in the pretreatment of aplastic anemia (AA) transplantation.
Professor Wang Sanbin said that sibling HLA total compatibility transplantation (MSD-HSCT) is still considered the standard of care for young severe AA (SAA) patients, and non-blood HLA total compatibility transplantation (MUD-HSCT) is rising as the main treatment for SAA
.
At present, about 10% of patients still have rejection using standard pretreatment regimens of MSD-HSCT and MUD-HSCT, so some research centers have explored
mephalan-containing pretreatment regimens.
A retrospective study in Japan showed that bone marrow transplantation with AA with fludarabine plus melphalan was safe and effective, with 100% overall survival (OS) and 100
% event-free survival (EFS).
A study in 920 Hospital included 20 patients with AA who underwent haploid hematopoietic stem cell transplantation in 2020-2021, using a pretreatment regimen combined with melphalan, with a median follow-up of 307 days, and the incidence of graft-versus-host disease (GVHD) was 5%, and the OS rate and EFS rate of patients were 95%.

Professor Wang Sanbin gave a report

The fifth session was presided over by Professor Liu Qiqi of the Institute of Hematology, Southern Medical University, and Professor Jiang Erlie of the Hematology Hospital of the Chinese Academy of Medical Sciences gave a detailed introduction on the topic of "Optimization of Hematopoietic Stem Cell Transplantation Pretreatment Program".

Patients with high-risk acute myeloid leukemia (AML) and MRD+ intermediate- and low-risk AML are the main patient groups
of AML allo-HSCT.
A prospective, multicenter clinical study conducted by Professor Jiang Erlie's center explored the use of melphalan combined with maryland, cyclophosphamide and cladribine pretreatment regimen for relapsed/refractory AML prior to allo-HSCT, and the results showed that the regimen had good safety and efficacy, with a 1-year recurrence rate of 22% and a disease-free survival (DFS) rate of 71%.
Treatment-related mortality was low, at 7%.

In addition, Professor Jiang Erlie said that in low- and medium-risk patients with persistently negative MRD, ASCT may be similar to fully compatible HSCT, and the replacement of donor allo-HSCT is slightly inferior
.
However, in patients with negative or persistently positive MRD, ASCT is less effective
.
Finally, Professor Jiang Erlie introduced that his center is currently exploring the application
of melpharun combined with cyclophosphamide and cytarabine in acute lymphoblastic leukemia (ALL) ASCT.

Professor Jiang Erlie gave a report