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61 Diseases |  |
45 Trials |
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45 Trials |  |
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- || Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Clinical, Review, Journal: Therapeutic plasma exchange as an intervention for gemtuzumab ozogamicin impaired hemoglobin scavenging: A case and systematic review. (Pubmed Central) - Apr 29, 2024
Among reported cases, patients undergoing TPE and those receiving steroids had improved outcomes. Practitioners should be aware of this rare drug side-effect and the potential utility of TPE for these patients.
- || Review, Journal: Advancements and Challenges in the Treatment of AML. (Pubmed Central) - Apr 25, 2024
Venetoclax (VEN) with a hypomethylating agent (HMA) is the standard-of-care frontline regimen for most older patients, except perhaps for those with an IDH1 mutation where ivosidenib with azacitidine may also be considered...This article focuses on recent updates and ongoing challenges in the management of AML, with a particular focus on the ongoing challenge of secondary AML and considerations regarding the selection of initial therapy in younger patients. An overview of common side effects and toxicities associated with targeted therapies is also presented here, along with recommended strategies to mitigate these risks.
- || Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Clinical, Retrospective data, Journal: Limited efficacy of 3?+?7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients. (Pubmed Central) - Apr 25, 2024
Our real-life multicenter study confirmed GO-based treatment efficacy with high MRD negativity rates in fit newly diagnosed AML patients, especially in those with low genetic risk and core binding factor, while limited benefits were observed in intermediate-risk AML. However, further validation on larger prospective cohorts is required.
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Extramedullary infiltration in pediatric acute myeloid leukemia: Results from the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative. (Pubmed Central) - Apr 22, 2024
However, further validation on larger prospective cohorts is required. EMI at diagnosis is an independent adverse prognostic risk factor for pediatric AML, and GO treatment potentially improves survival for patients with EMI at diagnosis.
- ||| Journal, Adverse events: Antibody drug conjugate adverse effects can be understood and addressed based on immune complex clearance mechanisms. (Pubmed Central) - Apr 21, 2024
We describe measurements that should help to identify those patients most likely to experience ASE due to ADC and we propose readily available treatments as well as therapies under development for other indications that should substantially reduce ASE associated with ADC. Our focus will be on the following FDA-approved ADC for which there are substantial literatures: gemtuzumab ozogamicin (Mylotarg) and inotuzumab ozogamicin; and trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd).
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment closed, Trial completion date: Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (clinicaltrials.gov) - Apr 18, 2024
P2, N=16, Active, not recruiting, Sponsor: Robert Redner, MD
Our focus will be on the following FDA-approved ADC for which there are substantial literatures: gemtuzumab ozogamicin (Mylotarg) and inotuzumab ozogamicin; and trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd). Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Dec 2028
- | Daurismo (glasdegib) / Pfizer, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date, Combination therapy, Post-transplantation: Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML (clinicaltrials.gov) - Apr 10, 2024
P3, N=414, Recruiting, Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Completed --> Active, not recruiting | Trial completion date: Feb 2023 --> Dec 2028 Trial primary completion date: Apr 2023 --> Apr 2024
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial primary completion date: CLAG-GO for Patients With Persistent, Relapsed or Refractory AML (clinicaltrials.gov) - Apr 4, 2024
P2, N=39, Recruiting, Sponsor: University of Maryland, Baltimore
Trial primary completion date: Apr 2023 --> Apr 2024 Trial completion date: Feb 2025 --> Feb 2027 | Trial primary completion date: Jan 2024 --> Jun 2026
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date: SWOG-S0703: Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 4, 2024
P2, N=133, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
- | Journal, Real-world evidence, Real-world: How comparable are patient outcomes in the "real-world" with populations studied in pivotal AML trials? (Pubmed Central) - Mar 31, 2024
Using data from 942 AML patients enrolled between 2012-2018, we assessed age and disease-matched control and interventional populations from published randomized trials that led to the registration of midostaurin, gemtuzumab ozogamicin, CPX-351, oral azacitidine, and venetoclax...Although real-world outcomes were comparable to some published studies, notable differences were apparent in others. If historical datasets were used to assess the impact of novel therapies, this work underscores the need to assess diverse datasets to enable geographic differences in treatment outcomes to be accounted for.
- || Talzenna (talazoparib) / Pfizer, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment open: Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Mar 27, 2024
P1, N=25, Recruiting, Sponsor: Roswell Park Cancer Institute
If historical datasets were used to assess the impact of novel therapies, this work underscores the need to assess diverse datasets to enable geographic differences in treatment outcomes to be accounted for. Active, not recruiting --> Recruiting
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Addition of single dose gemtuzumab ozogamicin to intensive induction chemotherapy in core-binding factor acute myeloid leukemia. (Pubmed Central) - Mar 26, 2024
The addition of single-dose GO, during induction, did not lead to a higher remission rate or survival benefit, when compared to intensive chemotherapy without GO. Further investigation into the incorporation of GO in the treatment algorithm for CBF-AML is needed.
- | Xospata (gilteritinib) / Astellas, Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Nippon Shinyaku, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment closed: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov) - Mar 12, 2024
P3, N=1400, Active, not recruiting, Sponsor: Children's Oncology Group
Further investigation into the incorporation of GO in the treatment algorithm for CBF-AML is needed. Recruiting --> Active, not recruiting
- Economy of Immunotherapy vs Chemotherapy for Relapsed/Refractory Acute Myeloid Leukemia () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_1226;
This study aimed to estimate cost-utility of targeted immunotherapies (gemtuzumab ozogamicin) and targeted non-immunotherapies (sorafenib, ivosidenib, enasidenib, gilteritinib) compared to salvage chemotherapy alone as treatment, using U.S. payer perspective. In the base-case analysis, both targeted immunotherapy and targeted non-immunotherapy were found to have a higher cost-utility when compared to salvage chemotherapy.
- Herceptin (trastuzumab) / Roche, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
A novel platform of diversified payloads to drive ADC innovation (Section 22) - Mar 5, 2024 - Abstract #AACR2024AACR_7995;
The best products resulting from the screening funnel have been subjected to a multidimensional analysis taking into consideration payload properties, tumor features and antigen expression in selected populations with the aim of identifying tumor types particularly sensitive to the payload. Our multidimensional approach coupling new payload linker with innovative MoA to careful selection of patients will allow to reach unprecedented efficacy and safety profile.
- BL-M11D1 / Biokin Pharma
BL-M11D1, a novel CD33-targeting ADC, demonstrates robust anti-tumor efficacy in preclinical evaluation (Section 21) - Mar 5, 2024 - Abstract #AACR2024AACR_5307;
In summary, these studies suggest BL-M11D1, a novel CD33-targeting ADC, is potentially efficacious in the treatment of CD33-expressing disease. The clinical phase I trial is being undertaken to evaluate safety, dosing and observations of preliminary signs of efficacy.
- Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Unveiling the correlation between gemtuzumab-ozogamicin efficacy and CD33+ expression in AML primary samples using the novel AML vitroscreen (Section 28) - Mar 5, 2024 - Abstract #AACR2024AACR_3969;
This system, serving as an ideal clinical translational setting in preclinical research, holds promise for developing tailored therapeutic strategies. Ultimately, this approach could significantly impact patient outcomes by offering improved strategies for both primary and recurrent AML cases.
- Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
pHLIP targeted intracellular delivery of calicheamicin (Section 29) - Mar 5, 2024 - Abstract #AACR2024AACR_2575;
Mylotarg, one of the first such ADCs, was voluntarily withdrawn from the market due to safety concerns...Besponsa, a related ADC, was approved for acute lymphocytic leukemia in 2017...Treatment of tumors led to the depletion of M2-TAMs within the tumor core. Thus, pHLIP-calicheamicin could be developed into an effective therapeutic for the treatment of solid tumors with abundant immuno-suppressive M2-TAMs.
- VIP943 / Vincerx
Activity of VIP943 on AML patient-derived leukemic blasts and healthy donor-derived bone marrow hematopoietic stem cells (Section 26) - Mar 5, 2024 - Abstract #AACR2024AACR_2537;
P1
At anticipated pharmacologic levels, VIP943 shows no adverse effects on HSCs unlike gem-oz suggesting an improved therapeutic index. In the ongoing first-in-human dose-escalation study in subjects with advanced CD123+ hematologic malignancies, VIP943 demonstrates a promising safety profile (NCT06034275).
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Outcome of Patients With Relapsed Acute Promyelocytic Leukemia. (Pubmed Central) - Mar 3, 2024
The combination of ATRA-ATO (+/- GO and idarubicin) is a highly effective salvage therapy in relapsed APL. The use of SCT may not be needed after first relapse-second remission but may be considered in subsequent relapses.
- ||| Daurismo (glasdegib) / Pfizer, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
P3 data, Journal: Randomized phase III GnG study on two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and double-blinded intensive post-remission therapy with or without glasdegib in patients with newly diagnosed acute myeloid leukemia. (Pubmed Central) - Feb 22, 2024
The use of SCT may not be needed after first relapse-second remission but may be considered in subsequent relapses. Not available.
- ||| Journal, Adverse events: A pharmacovigilance study on antibody-drug conjugate (ADC)-related neurotoxicity based on the FDA adverse event reporting system (FAERS). (Pubmed Central) - Feb 22, 2024
With the widespread application of newly launched ADC drugs, combining the FAERS data with other data sources is crucial for monitoring the neurotoxicity of ADCs. Further studies on the potential mechanisms and preventive measures for ADC-related neurotoxicity are necessary.
- Defitelio (defibrotide) / IRCCS San Raffaele Hospital, Jazz, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Rapidly Progressive Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction With Multi-Organ Dysfunction as a Complication of Non-transplant Associated Chemotherapy (San Diego Convention Center, Area K (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6022;
He was given gemtuzumab and ATRA was transitioned to arsenic. Defibrotide has been used to mitigate the level of hepatic epithelial cell necrosis, but the rapidness of this patient
- | Rydapt (midostaurin) / Novartis, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial primary completion date, Combination therapy: NCI-2019-01726: Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia (clinicaltrials.gov) - Feb 15, 2024
P1, N=18, Recruiting, Sponsor: Uma Borate
Defibrotide has been used to mitigate the level of hepatic epithelial cell necrosis, but the rapidness of this patient Trial primary completion date: Jan 2024 --> Jan 2025
- Rituxan (rituximab) / Roche
PRETREATMENT WITH RITUXIMAB IS SUSPECTED TO INCREASE RISK FOR OCCURRENCE OF VENO-OCCLUSIVE DISEASE IN PATIENTS WITH AGGRESSIVE LYMPHOMA AFTER ALLOGENEIC TRANSPLANT (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2329;
We suspect rituximab as a risk factor for the induction of VOD/SOS in patients after HSCT. More studies are required to confirm our findings.
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
EARLY DETECTION OF RELAPSE AND PROMPT TREATMENT WITH DLI FACILITATED BY PROPHYLACTIC LYMPHOCYTE STORAGE PERI-TRANSPLANT RESULTS IN EFFECTIVE DISEASE CONTROL IN ACUTE LEUKAEMIA AND MDS (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1358;
High levels of durable disease control are achieved and low rates of GvHD are seen resultant on DLI dose escalation. Prophylactic storage of DLI allows this approach and is cost effective
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
EARLY DETECTION OF RELAPSE AND PROMPT TREATMENT WITH DLI FACILITATED BY PROPHYLACTIC LYMPHOCYTE STORAGE PERI-TRANSPLANT RESULTS IN EFFECTIVE DISEASE CONTROL IN ACUTE LEUKAEMIA AND MDS (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1357;
High levels of durable disease control are achieved and low rates of GvHD are seen resultant on DLI dose escalation. Prophylactic storage of DLI allows this approach and is cost effective
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion, Trial completion date: Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4 (clinicaltrials.gov) - Feb 2, 2024
P2/3, N=225, Completed, Sponsor: Versailles Hospital
Prophylactic storage of DLI allows this approach and is cost effective Unknown status --> Completed | Trial completion date: Nov 2020 --> Sep 2023
- | Elzonris (tagraxofusp-erzs) / Menarini, Nippon Shinyaku, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment open, Phase classification, Combination therapy: GO-TAG: Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML (clinicaltrials.gov) - Jan 29, 2024
P1, N=36, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Unknown status --> Completed | Trial completion date: Nov 2020 --> Sep 2023 Not yet recruiting --> Recruiting | Phase classification: P1a/1b --> P1
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Incidence and Risk Factors of Early Onset VOD/SOS Differ in Younger vs Older Adults After Stem Cell Transplantation. (Pubmed Central) - Jan 24, 2024
There was no significant difference in rates of VOD in those receiving PTCy compared to those receiving alternate GVHD prophylaxis. Our data highlight the differences in incidence and predictors in VOD between younger (?25) and older (>25) adults undergoing allo-SCT.
- || Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Review, Journal: Gemtuzumab Ozogamicin in Acute Myeloid Leukemia: Efficacy, Toxicity, and Resistance Mechanisms-A Systematic Review. (Pubmed Central) - Jan 23, 2024
The drug's mechanism involves CD33 targeting and calicheamicin-induced DNA damage, leading to apoptosis and resistance mechanisms, including MDR and survival signaling, which impact treatment outcomes. Despite limited extramedullary toxicity, GO is associated with hematological side effects and hepatotoxicity.
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Fludarabine, Cytarabine, Granulocyte Colony-Stimulating Factor, and Idarubicin With Gemtuzumab Ozogamicin Improves Event-Free Survival in Younger Patients With Newly Diagnosed AML and Overall Survival in Patients With NPM1 and FLT3 Mutations. (Pubmed Central) - Jan 12, 2024
However, exploratory analyses show that patients with NPM1 and FLT3 mutations had substantial improvements in OS. By contrast, in patients with core binding factor AML, outcomes were excellent with DA + GO with no FLAG-Ida benefit.
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Retrospective data, Journal: Gemtuzumab ozogamicin for relapsed or primary refractory acute myeloid leukemia in children-the Polish Pediatric Leukemia and Lymphoma Study Group experience. (Pubmed Central) - Jan 12, 2024
Sinusoidal obstruction syndrome occurred in two children. The use of GO in severely pretreated children, including those under 15 years of age, with previous failure of AML treatment is a feasible and effective bridging therapy to allo-HSCT with an acceptable toxicity profile.
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Genetic variation in DNA damage response pathway and response to Gemtuzumab Ozogamicin in pediatric AML: a report from the Children's Oncology Group. (Pubmed Central) - Jan 10, 2024
Our results suggest that DDR pathway-based pharmacogenomic score holds potential to predict outcome in patients treated with GO which consists of DNA damaging cytotoxin, calicheamicin. The potential clinical relevance for this score to personalize GO in AML requires further validation in independent and expanded cohorts.
- ||| Venclexta (venetoclax) / Roche, AbbVie, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial primary completion date: Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Dec 15, 2023
P3, N=98, Recruiting, Sponsor: LLS PedAL Initiative, LLC
- ||| Journal, Adverse events, Real-world evidence, Real-world: Assessing safety concerns of interstitial lung disease associated with antibody-drug conjugates: a real-world pharmacovigilance evaluation of the FDA adverse event reporting system. (Pubmed Central) - Dec 15, 2023
Clinicians should be aware of these safety concerns and risk factors and implement early identification measures for their patients. Future research should prioritize comprehensively exploring the relationship between antibody-drug conjugates and lung diseases.
- || Venclexta (venetoclax) / Roche, AbbVie, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment closed: Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 (clinicaltrials.gov) - Dec 12, 2023
P1, N=18, Active, not recruiting, Sponsor: John Quigley
Future research should prioritize comprehensively exploring the relationship between antibody-drug conjugates and lung diseases. Recruiting --> Active, not recruiting
- Defitelio (defibrotide) / IRCCS San Raffaele Hospital, Jazz
Defibrotide Prophylaxis after Second Hematopoietic Cell Transplant in Pediatric Patients at Very High Risk for Veno-Occlusive Disease (301 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1324;
This study was not adequately powered to detect if prophylactic defibrotide lowered the incidence of VOD in VHR pediatric patients after 2nd HCT. A larger cohort will be reviewed.
- Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trem-Cel, a CRISPR/Cas9 Gene-Edited Allograft Lacking CD33, Shows Rapid Primary Engraftment with CD33-Negative Hematopoiesis in Patients with High-Risk Acute Myeloid Leukemia (AML) and Avoids Hematopoietic Toxicity during Gemtuzumab Ozogamicin (GO) Maintenance Post-Hematopoietic Cell Transplant (HCT). () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_981;
P1/2
The exposure at 0.5mg/m2 GO dose corresponded to higher doses of GO in AML patients, possibly due to reduction of the CD33 hematopoietic antigen sink. Minimal cytopenias have been observed thus far after treatment with GO, supporting the hypothesis that CD33 deletion can protect donor cells from CD33-targeted therapies.
- | ABBV-011 / AbbVie
Preclinical, Journal: Preclinical Characterization of Catabolic Pathways and Metabolism of ABBV-011, a Novel Calicheamicin-Based SEZ6 Targeting Antibody Drug Conjugate. (Pubmed Central) - Dec 5, 2023
Significance Statement Several in vitro and in vivo stability studies of ABBV-011, a calicheamicin-based ADC, identified circulating metabolites and catabolites and suggested that disulfide cleavage may be a key liability for the conjugated linker-payload. These observations may be relevant to other disulfide-linked ADCs, such as Mylotarg and Besponsa, both of which have reported similar half-lives that possibly indicate instability.
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Fractionated vs single-dose gemtuzumab for AML. (Pubmed Central) - Nov 27, 2023
These observations may be relevant to other disulfide-linked ADCs, such as Mylotarg and Besponsa, both of which have reported similar half-lives that possibly indicate instability. No abstract available
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Gemtuzumab ozogamicin in AML: the next chapter. (Pubmed Central) - Nov 21, 2023
No abstract available No abstract available
- | Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Pediatric acute myeloid leukemia - novel approaches. (Pubmed Central) - Nov 20, 2023
Ongoing studies may soon define this as standard as well. After many years in which few new therapies have become available for children with AML, recent and upcoming advances may soon dramatically alter the therapeutic landscape.
- ||| Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Nippon Shinyaku, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial termination, Trial primary completion date: UCHMC 1812: CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia (clinicaltrials.gov) - Nov 18, 2023
P1, N=13, Terminated, Sponsor: Jonsson Comprehensive Cancer Center
After many years in which few new therapies have become available for children with AML, recent and upcoming advances may soon dramatically alter the therapeutic landscape. Trial completion date: Jul 2025 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2024 --> Oct 2023; slow accrual
- | Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Nippon Shinyaku, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Trial completion date, Trial primary completion date, Combination therapy: NCI-2018-01812: Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (clinicaltrials.gov) - Nov 18, 2023
P2, N=50, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Jul 2025 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2024 --> Oct 2023; slow accrual Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
- | Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Journal: Fractionated Versus Single Dose Gemtuzumab Ozogamicin with Determinants of Benefit in Older AML: UK NCRI AML18 Trial. (Pubmed Central) - Nov 17, 2023
This benefit from GO2 was dependent on allo-transplant to translate the better leukemia clearance into improved survival. CT# ISRCTN 31682779.
- | Xospata (gilteritinib) / Astellas, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Enrollment open: AGORA-1: A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD Relapse/Refractory (R/R) AML (clinicaltrials.gov) - Nov 12, 2023
P2, N=50, Recruiting, Sponsor: Centre Antoine Lacassagne
CT# ISRCTN 31682779. Not yet recruiting --> Recruiting
- Defitelio (defibrotide) / IRCCS San Raffaele Hospital, Jazz, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Incidence and Risk Factors of Veno-Occlusive Disease Are Different in Younger Versus Older Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6380;
Median age was 56 years and 60% were male. Patients primarily had acute myeloid leukemia/myelodysplastic syndrome (AML/MDS; 60%), acute lymphoblastic leukemia (ALL; 13%), or myeloproliferative neoplasms (13%).
- VCAR33ALLO / Vor Biopharma
Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia after Allogeneic Hematopoietic... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6319;
CD33 is a preferential target for AML CAR T cell therapy as it is expressed on the majority (>80%) of AML blasts and because prior clinical experience with gemtuzumab ozogamicin (GO; tradename: Mylotarg TM ) has demonstrated the safety and efficacy of targeting CD33...Patients will receive lymphodepletion on days -5 to -2 with fludarabine (total 120 mg/m 2 ) and cyclophosphamide (total 1000 mg/m 2 ) followed by infusion of VCAR33 on Day 0...*NCT number pending. Clinical trial information submitted to CT.gov on July 19, 2023.
- Rydapt (midostaurin) / Novartis, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
The Genomic Landscape and Its Clinical Implication in NPM1-Mutated AML Patients: A Study within the AMLSG 09-09 Clinical Trial (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5747;
P3
The co-mutational pattern clearly differs between younger and older NPM1 mut AML pts. Using this large dataset allowed the identification of secondary and tertiary gene-gene interactions with significant impact on outcome.