This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.

开始日期2021-08-15

申办/合作机构

河北森朗生物科技有限公司

[+1]

NCT03249870 / Active, not recruiting临床2期IIT

A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia

The aim of the present EWALL-INO study is to confirm very promising results obtained with a combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that purpose, safety and efficacy of a weekly INO administration combined to mild-intensity chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be given as part of the remission induction treatment phase during the first 2 treatment cycles only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal prophylaxis only; then, all responding patients will received standard INO-free chemotherapy as consolidation and maintenance.

开始日期2017-12-28

申办/合作机构

Centre Hospitalier de Versailles

100 项与 CD22阳性前体B细胞急性淋巴细胞白血病相关的临床结果

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100 项与 CD22阳性前体B细胞急性淋巴细胞白血病相关的转化医学

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0 项与 CD22阳性前体B细胞急性淋巴细胞白血病相关的专利（医药）

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项与 CD22阳性前体B细胞急性淋巴细胞白血病相关的文献（医药）

2024-07-01·Pediatric Drugs

Inotuzumab Ozogamicin: First Pediatric Approval

Review

作者: Dhillon, Sohita

Inotuzumab ozogamicin (BESPONSA™) is a CD22-targeted monoclonal antibody drug conjugate (ADC) developed by Pfizer for the treatment of CD22-postive B-cell precursor acute lymphoblastic leukaemia (ALL). Inotuzumab ozogamicin comprises a humanized IgG4 anti-CD22 monoclonal antibody covalently linked to the potent DNA-binding cytotoxic agent N-acetyl-gamma-calicheamicin dimethylhydrazide (CalichDMH) via a linker. Inotuzumab ozogamicin binds to CD22-expressing tumour cells, facilitating the delivery of conjugated CalichDMH, which after intracellular activation induces double strand DNA breaks, ultimately leading to cell cycle arrest and apoptotic cell death. Inotuzumab ozogamicin is approved in the USA, Europe and several countries worldwide for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in adults. On 6 March 2024, inotuzumab ozogamicin received its first pediatric approval in the USA for this indication in patients aged ≥ 1 years. Inotuzumab ozogamicin has since been approved in Japan in March 2024 for the same indication in pediatric patients. This article summarizes the milestones in the development of inotuzumab ozogamicin leading to this first approval for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in pediatric patients.

2024-01-20·Journal of Clinical Oncology

Inotuzumab Ozogamicin as Induction Therapy for Patients Older Than 55 Years With Philadelphia Chromosome–Negative B-Precursor ALL

Article

作者: Spriewald, Bernd ; Wäsch, Ralph ; Lenz, Georg ; Martin, Sonja ; Schwab, Katjana ; Raffel, Simon ; Serve, Hubert ; Wethmar, Klaus ; Marx, Julia ; Alakel, Nael ; Brüggemann, Monika ; Berdel, Wolfgang E ; Hanoun, Maher ; Scholl, Sebastian ; Stelljes, Matthias ; Knaden, Julian ; Sauer, Tim ; Rank, Andreas ; Gökbuget, Nicola ; Kondakci, Mustafa ; Reiser, Lena ; Hänel, Mathias ; Pfeifer, Heike

PURPOSE Despite recent advances in adapting the intensity of treatment for older patients with ALL, current protocols are associated with high rates of early deaths, treatment-related toxicity, and dismal prognosis. We evaluated inotuzumab ozogamicin and dexamethasone (Dex) as induction therapy in older patients with ALL within the German Multicenter Study Group for Adult ALL (GMALL). PATIENTS AND METHODS The open-label, multicenter, phase II, INITIAL-1 trial enrolled 45 patients older than 55 years with newly diagnosed, CD22-positive, BCR::ABL-negative B-precursor ALL (B-ALL). Patients received up to three cycles of inotuzumab ozogamicin/Dex and up to six cycles of age-adapted GMALL consolidation and maintenance therapy. RESULTS Forty-three evaluable patients with common/pre-B (n = 38) and pro-B ALL (n = 5), with a median age of 64 years (range, 56-80), received at least two cycles of inotuzumab ozogamicin induction therapy. All patients achieved complete remission (CR/CR with incomplete hematologic recovery). Twenty-three (53%) and 30 (71%) patients had no evidence of molecularly assessed measurable residual disease (minimum 10e−4 threshold) after the second and third inductions, respectively. After a median follow-up of 2.7 years, event-free survival at one (primary end point) and 3 years was 88% (95% CI, 79 to 98) and 55% (95% CI, 40 to 71), while overall survival (OS) was 91% (95% CI, 82 to 99) and 73% (95% CI, 59 to 87), respectively. None of the patients died during 6 months after the start of induction. Most common adverse events having common toxicity criteria grade ≥3 during induction were leukocytopenia, neutropenia, thrombocytopenia, anemia, and elevated liver enzymes. One patient developed nonfatal veno-occlusive disease after induction II. CONCLUSION Inotuzumab ozogamicin–based induction followed by age-adapted chemotherapy was well tolerated and resulted in high rates of remission and OS. These data provide a rationale for integrating inotuzumab ozogamicin into first-line regimens for older patients with B-ALL.

2017-05-01·Haematologica

Hyper-CVAD + epratuzumab as a salvage regimen for younger patients with relapsed/refractory CD22-positive precursor B-cell acute lymphocytic leukemia

Letter

作者: Garnier, Alice ; Charbonnier, Aude ; Raffoux, Emmanuel ; Huguet, Francoise ; Chevallier, Patrice ; Le Houerou, Claire ; Maury, Sébastien ; Isnard, Francoise ; Gallego-Hernanz, Maria-Pilar ; Béné, Marie-C ; Chantepie, Sylvain ; Rialland, Fanny ; Marchand, Tony ; Goldenberg, David M ; Peterlin, Pierre ; Wegener, William A ; Dombret, Hervé ; Guillaume, Thierry ; Robillard, Nelly ; Thomas, Xavier ; Leguay, Thibaut

This article discusses about Hyper-CVAD + epratuzumab as a salvage regimen for younger patients with relapsed/refractory CD22-pos. precursor B-cell acute lymphocytic leukemia.