Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Etoposide

Ifosfamide

Etoposide phosphate

Tyrosine Kinase Inhibitors

Isophosphamide mustard

Mechlorethamine

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine

Children and adolescents with relapsed or refractory drug resistant osteosarcoma

(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle

Sulfatinib

(1) Etoposide: 100 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle, a total of 5 cycles. The dose of etoposide can be reduced to 80 mg/m2/day and 60 mg/m2/day.;

(1) Isophosphamide: 3000 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle for 5 cycles. The dose of ifosfamide can be reduced to 2400 mg/m2/day and 1800 mg/m2/day.

Isophosphamide

Zhaoming Ye, PhD

zengjie zhang, MD

Yi Yang, PhD

Zhenfeng Li, PhD

Weibin Zhang, PhD

Sung Taek Jung, PhD

zhaoming Ye, PhD

Binhao Li, PhD

Shengdong Wang, MD

Xin Huang, PhD

Peng Lin, MD

This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib).

The study consists of 2 cohorts:

Cohort 1 (Traditional chemotherapy) will evaluate the efficacy of ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.

Cohort 2 (Combination Expansion) will evaluate the efficacy of Sulfatinib in combination with ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.

Sulfatinib will be provided as hard capsules containing 300 mg Sulfatinib. Sulfatinib capsules should be dissolved in water or apple juice for those who are unable to swallow capsules.

A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.

Complete response (CR), all target and non-target lesions (non-lymph nodes) disappear, and the diameter of all pathologic lymph nodes (both target and non-target) must be reduced to \<10 mm; Partial response (PR), using baseline total diameter as reference, reduced the total diameter of target lesions by at least 30%.

From the date of the first administration of the study drug to disease progression or death, whichever occurs first.

Complete response (CR)/ partial response (PR) was first recorded until disease progression was first recorded until the data cutoff date.

Chonnam National University

Peking University People's Hospital

Qilu Hospital of Shandong University

Ruijin Hospital

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Analgesics

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Mitoxantrone

Rituximab

Lenalidomide

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

R-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide

X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide

Mitoxantrone hydrochloride liposome

1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1\~4

MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2\~4

X: Orelabrutinib

EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2\~4

X: Chidamide

TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2\~4

X: Penpulimab

Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2\~4

X: Lenalidomide

Jinhua Liang, M.D

Wei Xu, PhD& MD

Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. At present, there are no studies on the efficacy and safety of R-MINE+X regimen based on molecular typing in the treatment of R/R DLBCL. Therefore, based on NGS, R/R DLBCL was divided into different molecular types (MCD subtype, BN2 subtype, EZB subtype, A53 subtype and other subtype), and on this basis, different molecular types of targeted drugs (X: MCD/BN2 subtype - BTK inhibitor, EZB subtype - Chidamide, A53 subtype - PD-1 monoclonal antibody and other type - lenalidomide) were used to treat R/R DLBCL. The main purpose was to observe the effectiveness and safety of the program in R/R DLBCL.

R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy

Complete remission rate(CRR) after 4 cycles of R-MINE+X chemotherapy

Time from reaching CR or PR for the first time to disease progression

from date of inclusion to date of progression, relapse, or death from any cause

from the date of inclusion to date of death, irrespective of cause

The safety of the drug was evaluated by NCI-CTC AE 5.0 standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma	NCT05784987	Diffuse Large B...	Rituximab Mitoxantrone hy... Isophosphamide Etoposide X: Orelabrutini... X: Chidamide X: Penpulimab X: Lenalidomide	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for isophosphamide