Delving into the Latest Updates on Vincristine Sulfate Liposome with Synapse

This is a phase-II study to evaluate the efficacy of a salvage regimen in children with relapsed T-cell ALL or lymphoma. Peg-asparaginase, mitoxantrone, intrathecal triples (IT) (intrathecal methotrexate/hydrocortisone/cytarabine) (ITMHA) and dexamethasone are commonly used drugs to treat relapsed or refractory acute lymphocytic leukemia or lymphoma (ALL). In this study, the investigators want to know if adding three drugs called panobinostat, bortezomib and liposomal vincristine (VSLI) to this regimen will result in remission (no signs or symptoms of leukemia or lymphoma).
Panobinostat has been approved by the FDA for treating adults with multiple myeloma, but it has not been approved for use in children and has not been given together with the other drugs used in this study. It has not been widely studied in children.
VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has not yet been approved for treating children with leukemia or lymphoma.
Bortezomib has been approved by the FDA for treating adults with a cancer called multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved for treating children.
PRIMARY OBJECTIVE:
To estimate the complete remission (CR) rate for patients with T-cell lymphoblastic leukemia and lymphoma in first relapse.
SECONDARY OBJECTIVES:
To evaluate minimal residual disease (MRD) levels at end of each block of therapy.
To describe the toxicities of vincristine sulfate liposome injection (VSLI) when used in combination with chemotherapy and bortezomib.

Start Date23 Nov 2016

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

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100 Clinical Results associated with Vincristine Sulfate Liposome

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100 Translational Medicine associated with Vincristine Sulfate Liposome

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100 Patents (Medical) associated with Vincristine Sulfate Liposome

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2

Literatures (Medical) associated with Vincristine Sulfate Liposome

01 Feb 2025·ORAL ONCOLOGY

Undifferentiated small round cell sarcoma of the parapharyngeal space in a 4.5-year-old patient:A rare case report

Letter

Author: Kang, Xinmei ; Wang, Lei

This case report describes a 4.5-year-old girl diagnosed with a rare Undifferentiated Small Round Cell Sarcoma (USRCS) originating in the parapharyngeal space with multiple lung metastases. Diagnostic workups, including imaging, immunohistochemistry, and genetic sequencing, identified the tumor as an unclassified subtype of USRCS. The patient was treated with the Ewing sarcoma chemotherapy regimen, alternating between VDC (vincristine + doxorubicin + cyclophosphamide) and IE (ifosfamide + etoposide), in combination with bevacizumab. The tumor achieved complete remission, and no recurrence has been observed during follow-up.

Frontiers in Pharmacology

Efficacy, safety and cost-effectiveness of obinutuzumab in patients with follicular lymphoma: a rapid review

Review

Author: Bu, Yishan ; Zhang, Yi ; Yang, Yiheng ; Dou, Qianqian ; Zhang, Xinran ; Men, Peng ; Zhang, Ruixia ; Xiao, Ying ; Gao, Huier ; Wang, Chao ; Qin, Yinpeng ; Dong, Yunzhuo

Background:

Obinutuzumab was approved in China in June 2021 used in combination with chemotherapy (followed by obinutuzumab maintenance) for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL). The clinical application of obinutuzumab has recently begun in China, but there is a lack of evidence to determine under which circumstances it should be considered the treatment of choice. A comprehensive assessment is necessary to evaluate the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL.

Objective:

To summarize the evidence on the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL, aiming to provide medical professionals with evidence for informed choices in clinical practice.

Methods:

The approach to this evidence synthesis was a rapid review of systematic reviews/meta-analyses (SR/meta-analyses), health technology assessment (HTA) reports, and pharmacoeconomic studies that brings together and summarizes the efficacy, safety, and cost-effectiveness of obinutuzumab in adult patients with FL. A literature search was conducted across multiple databases, including PubMed, Embase, Wanfang, CNKI, Weipu database, the Cochrane Library, the Centre for Reviews and Dissemination (CRD) database, International Network of Agencies for Health Technology Assessment (INAHTA) and Canada’s Drug Agency (CDA-AMC), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), National Institute For Health and Care Excellence (NICE), Institute For Clinical And Economic Review (ICER), Grey Literature Database and Grey Net International. The studies on obinutuzumab for FL were searched in full text with obinutuzumab, systematic review, meta-analysis, economics, cost, and health technology assessment as keywords, with a search time frame from the date of database creation to 29 November 2024. The literature was screened based on predefined inclusion and exclusion criteria, and data were meticulously extracted and synthesized by two authors. Simultaneously, the quality of the literature was thoroughly assessed.

Results:

Obinutuzumab based chemotherapy (the chemotherapy regimen-cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); or bendamustine) significantly prolonged progression free survival (PFS) compared to other chemotherapy regimen at primary and updated analyses. The incidence of grade 3–5 AEs, infusion-related reactions (IRRs), and infection were higher in the obinutuzumab based chemotherapy group compared to other chemotherapies. The economic researches conducted in China, United States, Japan, Italy and Norway had demonstrated that obinutuzumab-based chemothrepy was cost-effective compared to other chemothrepies. Although obinutuzumab significantly prolonged PFS and was cost-effective, its safety profile was considered lower.

Conclusion:

Compared with other chemothrapy regimen, obinutuzumab based chemotherapy significantly prolonged PFS and was cost-effective, while its safety profile was considered lower. Therefore, medical professionals should be caution when using or introducing obinutuzumab treatment for FL patients.

100 Deals associated with Vincristine Sulfate Liposome

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External Link

KEGG	Wiki	ATC	Drug Bank
D02197	Vincristine Sulfate Liposome	L01CA02	DB00541

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	US	Acrotech Biopharma LLCStartup	09 Aug 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD20 positive B-Cell Lymphoma	Phase 3	DE	Spectrum Pharmaceuticals, Inc.	01 Nov 2011
CD20 positive Diffuse Large B-Cell Lymphoma	Phase 3	DE	Spectrum Pharmaceuticals, Inc.	01 Nov 2011
Refractory acute myeloid leukemia	Phase 2	US	Spectrum Pharmaceuticals, Inc.	05 Jun 2015
Relapsing acute myeloid leukemia	Phase 2	US	Spectrum Pharmaceuticals, Inc.	05 Jun 2015
Uveal Melanoma	Phase 2	US	Spectrum Pharmaceuticals, Inc.	01 Nov 2007
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	Phase 2	US	Spectrum Pharmaceuticals, Inc.	01 May 2007
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	Phase 2	CA	Spectrum Pharmaceuticals, Inc.	01 May 2007
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	Phase 2	DE	Spectrum Pharmaceuticals, Inc.	01 May 2007
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	Phase 2	IL	Spectrum Pharmaceuticals, Inc.	01 May 2007
Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	Phase 2	GB	Spectrum Pharmaceuticals, Inc.	01 May 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01439347 (CTgov)	Phase 3	Acute Lymphoblastic Leukemia	26	Vincristine Sulfate Injection (VSI) (Vincristine Sulfate Injection (VSI))	fvhzfyyzqy(ficbsziref) = keseczdxrf sbononvlec (sxxhzzbukm, opvmljqkdh - fihqovinms) View more	-	09 Sep 2021
NCT01439347 (CTgov)	Phase 3	Acute Lymphoblastic Leukemia	26	Vincristine Sulfate Liposomes Injection (VSLI) (Marqibo)	fvhzfyyzqy(ficbsziref) = zaihwhxrvi sbononvlec (sxxhzzbukm, nxavxcrxrz - yamuojyclv) View more	-	09 Sep 2021
NCT00506142 (CTgov)	Phase 2	Uveal Melanoma	54	Marqibo® (vincristine sulfate liposomes injection) (Cohort 1)	pnlmjltybq(cfslwvyzlm) = ryorhxzgik cesvuttkod (ibfowexzof, nehrtmjhaq - myoarlyqsg) View more	-	27 Nov 2019
NCT00506142 (CTgov)	Phase 2	Uveal Melanoma	54	Marqibo® (vincristine sulfate liposomes injection) (Cohort 2)	pnlmjltybq(cfslwvyzlm) = lykpztkjju cesvuttkod (ibfowexzof, lmrxdsruhv - zjhmjsbivi) View more	-	27 Nov 2019
NCT02337478 (CTgov)	Phase 2	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia	5	Laboratory Biomarker Analysis+Vincristine Sulfate Liposome	nqpqmoqusv(triezgtxjd) = hmibzsfzbo qzteamwofz (mwpzframna, frtfuvodab - pcnfqbcllq) View more	-	01 Aug 2019
NCT00495079 (HBS407 \| RALLY, CTgov)	Phase 2	Recurrent Adult Acute Lymphoblastic Leukemia \| Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	65	Marqibo® (vincristine sulfate liposomes injection)	jcnlauksla(sqfwghyrnj) = vbmsagthyw ftzrfozgvz (atvmpyukma, pykdhgibwk - kgblsuhhug) View more	-	29 Nov 2012
NCT00144963 (CTgov)	Phase 1/2	Acute Lymphoblastic Leukemia	36	Dexamethasone+Vincristine Sulfate Liposomes Injection	prtynrkddp(tshewtyzmg) = vxxvbylbie hgfwvhthkk (bqurrcmiew, kqcvmmxwal - rchwwojfie) View more	-	18 Jan 2012