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our Premium Content: News alerts, weekly reports and conference plannersDRUG CLASS:
Immunosuppressant
DRUG CLASS:
Immunosuppressant
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News alerts, weekly reports and conference planners
Related drugs:
2d
Successful Treatment with Mycophenolate Mofetil in a Patieint with Anti-MDA 5 Antibody-positive Interstitial Lung Disease and Posterior Reversible Encephalopathy syndrome: A Case Report. (PubMed, Intern Med)
However, the patient reported a severe headache following treatment with oral prednisolone and tacrolimus. Tacrolimus was discontinued, and mycophenolate mofetil was instead administered with a favorable outcome. Mycophenolate mofetil should therefore be considered as an alternative treatment for anti-MDA-5-positive interstitial lung disease in cases where calcineurin inhibitors cannot be used.
Journal
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IFIH1 (Interferon Induced With Helicase C Domain 1)
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prednisolone
4d
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure. (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Masonic Cancer Center, University of Minnesota
New P2 trial • Post-transplantation
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Rituxan (rituximab) • cyclophosphamide • fludarabine IV • Neupogen (filgrastim) • methylprednisolone sodium succinate
4d
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=64, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
Trial completion date • Trial primary completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
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gemcitabine • Rituxan (rituximab) • clofarabine • busulfan
9d
I4BiS: 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation (clinicaltrials.gov)
P3, N=346, Active, not recruiting, Hospices Civils de Lyon | Recruiting --> Active, not recruiting
Enrollment closed • Biopsy
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methylprednisolone sodium succinate
10d
Immune-related adverse event-associated sclerosing cholangitis due to immune checkpoint inhibitors: imaging findings and treatments. (PubMed, Jpn J Clin Oncol)
Various bile duct imaging findings of immune-related adverse event-sclerosing cholangitis were revealed; transpapillary bile duct biopsy may be useful in the diagnosis of immune-related adverse event-sclerosing cholangitis. Despite the combination of multiple immunosuppressive agents, prognosis of immune-related adverse event-sclerosing cholangitis remains poor. Longer follow-up and larger clinical studies are necessary to establish its treatment strategy.
Journal • Adverse events • Checkpoint inhibition
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CD8 (cluster of differentiation 8)
15d
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov)
P4, N=200, Recruiting, Novaliq GmbH | Not yet recruiting --> Recruiting
Enrollment open
24d
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
P2, N=140, Recruiting, M.D. Anderson Cancer Center | N=100 --> 140
Enrollment change
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cyclosporin A microemulsion • methylprednisolone sodium succinate
26d
CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov)
P2, N=216, Active, not recruiting, CalciMedica, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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IL6 (Interleukin 6)
29d
KOURAGE: A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" (clinicaltrials.gov)
P2, N=150, Not yet recruiting, CalciMedica, Inc.
New P2 trial
29d
Immune reconstitution after single-unit umbilical cord blood transplantation using anti-thymoglobulin and myeloablative conditioning in adults with hematological malignancies. (PubMed, Ann Hematol)
However, T cell recovery, particularly CD4+ T cells, was significantly delayed. To enhance T cell recovery, it may be crucial to consider UCB units with higher cellularity and optimize ATG doses in conditioning.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
30d
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis (clinicaltrials.gov)
P4, N=17, Completed, Santen SAS | Unknown status --> Completed | N=33 --> 17
Trial completion • Enrollment change
30d
ONSET: 1 vs 7 RATG Infusions in Renal Transplantation (clinicaltrials.gov)
P=N/A, N=75, Not yet recruiting, Mario Negri Institute for Pharmacological Research
New trial
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Simulect (basiliximab)
30d
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant (clinicaltrials.gov)
P2, N=59, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
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TP53 (Tumor protein P53) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD34 (CD34 molecule) • CD4 (CD4 Molecule)
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TP53 mutation
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cyclophosphamide • melphalan • fludarabine IV • thiotepa • busulfan
1m
Pharmacogenetic Effect of Thiopurine Methyl Transferase (TPMT) Gene Expression and Serum TNF on the Imuran Response in Ulcerative Colitis (UC) Iraqi Patients. (PubMed, Rep Biochem Mol Biol)
A distinct correlation was identified between TPMT gene expression and Imuran therapy outcomes in UC patients. Further investigation is warranted to elucidate the underlying mechanism, positioning the TPMT gene as a potential therapeutic target for mitigating the impact of UC.
Journal
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TNFA (Tumor Necrosis Factor-Alpha)
1m
PTAAK: Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (clinicaltrials.gov)
P4, N=60, Recruiting, Roy D. Bloom, MD | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Dec 2023 --> Mar 2025
Trial completion date • Trial primary completion date
1m
Stem Cell Transplantation in Crohn's Disease (clinicaltrials.gov)
P1/2, N=15, Recruiting, Cedars-Sinai Medical Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
Trial completion date • Trial primary completion date
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cyclophosphamide • fludarabine IV • mesna • Neupogen (filgrastim) • methylprednisolone sodium succinate
1m
CY-MET-RIC: Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation (clinicaltrials.gov)
P2, N=82, Not yet recruiting, Nantes University Hospital | N=60 --> 82
Enrollment change • Post-transplantation
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cyclophosphamide • clofarabine • fludarabine IV • thiotepa • busulfan
1m
TaC:Drop: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs (clinicaltrials.gov)
P4, N=300, Recruiting, Edward Geissler | Not yet recruiting --> Recruiting
Enrollment open • Head-to-Head
1m
TRIUMPH: TReatment for ImmUne Mediated PathopHysiology (clinicaltrials.gov)
P2, N=163, Recruiting, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase classification: P2b --> P2 | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Apr 2025 --> Jan 2026
Phase classification • Trial completion date • Trial primary completion date
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methylprednisolone sodium succinate
2ms
IMPROVE-MC: Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy. (clinicaltrials.gov)
P4, N=100, Recruiting, Medical University of Warsaw | Not yet recruiting --> Recruiting | Trial completion date: Sep 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Sep 2027
Enrollment open • Trial completion date • Trial primary completion date • Biopsy
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prednisone
2ms
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov)
P3, N=110, Not yet recruiting, AbbVie
New P3 trial
2ms
OPERATOR: Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ (clinicaltrials.gov)
P4, N=60, Recruiting, Vanderbilt University Medical Center | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
Trial completion date • Trial primary completion date • HEOR
2ms
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine (clinicaltrials.gov)
P4, N=200, Not yet recruiting, Novaliq GmbH
New P4 trial
2ms
RIC Regimen for Elderly or High Comorbidity Burden Patients Receiving Haplo-HSCT (clinicaltrials.gov)
P2, N=50, Recruiting, Peking University People's Hospital | Unknown status --> Recruiting | Trial completion date: Sep 2021 --> Sep 2025 | Trial primary completion date: Sep 2021 --> Sep 2025
Enrollment open • Trial completion date • Trial primary completion date
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cytarabine • cyclophosphamide • fludarabine IV • busulfan
2ms
Mefloquine enhances the efficacy of anti-PD-1 immunotherapy via IFN-γ-STAT1-IRF1-LPCAT3-induced ferroptosis in tumors. (PubMed, J Immunother Cancer)
In conclusion, our study demonstrated a novel mechanism by which LPCAT3 is regulated, and demonstrated that Mef is a highly promising new target that can be utilized to enhance the efficacy of anti-PD-1 immunotherapy.
Journal • PD(L)-1 Biomarker • IO biomarker
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IFNG (Interferon, gamma) • IRF1 (Interferon Regulatory Factor 1) • STAT1 (Signal Transducer And Activator Of Transcription 1) • LPCAT3 (Lysophosphatidylcholine Acyltransferase 3)
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IRF1 expression
2ms
Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis (clinicaltrials.gov)
P=N/A, N=120, Not yet recruiting, Zhongshan Ophthalmic Center, Sun Yat-sen University
New trial • Head-to-Head
2ms
ATGAM General Investigation (clinicaltrials.gov)
P=N/A, N=100, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting
Enrollment closed
2ms
Envarsus Neurotoxicity Burden in Liver Transplant Patients (clinicaltrials.gov)
P4, N=30, Completed, Medical University of South Carolina | Active, not recruiting --> Completed
Trial completion
2ms
Downstaging Hepatocellular Carcinoma with Checkpoint Inhibitor Therapy Improves Access to Curative Liver Transplant. (PubMed, J Gastrointest Cancer)
We describe nine patients with HCC outside Milan with inadequate response with liver-directed therapy, who achieved marked responses with CPIT, allowing for consideration of successful liver transplantation. Our case series supports the consideration of locoregional therapies and CPIT for downstaging to within transplant criteria.
Journal • Checkpoint inhibition
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AFP (Alpha-fetoprotein)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab)
2ms
Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors (clinicaltrials.gov)
P2, N=9, Terminated, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2024 --> Mar 2024; Low accrual
Trial completion date • Trial termination • Trial primary completion date
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TP53 (Tumor protein P53) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • RUNX1 (RUNX Family Transcription Factor 1) • KMT2A (Lysine Methyltransferase 2A) • CRLF2 (Cytokine Receptor Like Factor 2) • IKZF1 (IKAROS Family Zinc Finger 1) • NUP214 (Nucleoporin 214) • CDKN1A (Cyclin-dependent kinase inhibitor 1A) • DEK (DEK Proto-Oncogene)
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TP53 mutation • RUNX1 mutation • KMT2A rearrangement • IKZF1 mutation • MLL mutation • Chr t(9;11)
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Rituxan (rituximab) • cyclophosphamide • clofarabine • melphalan • fludarabine IV • thiotepa • busulfan
2ms
LIFT: Liver Immunosuppression Free Trial (clinicaltrials.gov)
P4, N=116, Terminated, King's College London | Active, not recruiting --> Terminated; Primary endpoint not reached.
Trial termination
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cyclosporine
2ms
Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2) (clinicaltrials.gov)
P3, N=350, Recruiting, Oculis | Not yet recruiting --> Recruiting
Enrollment open
2ms
rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT) (clinicaltrials.gov)
P3, N=138, Recruiting, Institute for Clinical and Experimental Medicine | Trial primary completion date: Apr 2022 --> Apr 2024
Trial primary completion date
2ms
2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies (clinicaltrials.gov)
P2, N=10, Active, not recruiting, Sidney Kimmel Cancer Center at Thomas Jefferson University | Trial primary completion date: Sep 2023 --> Sep 2024
Trial primary completion date
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cyclophosphamide
2ms
Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR. (clinicaltrials.gov)
P1, N=35, Recruiting, Yale University | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Jul 2024
Trial completion date • Trial primary completion date
2ms
Extended-Release Tacrolimus Following Liver Transplantation (clinicaltrials.gov)
P4, N=94, Recruiting, University of Alberta | Trial primary completion date: Feb 2024 --> Jul 2025
Trial primary completion date
3ms
EVOKE-RT: Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus (clinicaltrials.gov)
P4, N=46, Completed, Sentara Norfolk General Hospital | Recruiting --> Completed
Trial completion
3ms
3M-RGD: Graves' Disease Remission Study: MycoMeth Combo (clinicaltrials.gov)
P2/3, N=205, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting
Enrollment open
3ms
Fludarabine Based RIC for Bone Marrow Failure Syndromes (clinicaltrials.gov)
P1, N=25, Recruiting, Children's Hospital of Philadelphia | N=75 --> 25 | Trial completion date: Dec 2025 --> Dec 2026
Enrollment change • Trial completion date
|
cyclophosphamide • fludarabine IV
3ms
TaC:Drop: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs (clinicaltrials.gov)
P4, N=300, Not yet recruiting, Edward Geissler
New P4 trial • Head-to-Head
3ms
CIRTEN SPK: CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients (clinicaltrials.gov)
P2/3, N=30, Recruiting, University of Wisconsin, Madison | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
Trial completion date • Trial primary completion date • HEOR
3ms
A Randomized Multicenter Study for Isolated Skin Vasculitis (clinicaltrials.gov)
P2, N=90, Recruiting, University of Pennsylvania | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
Trial completion date • Trial primary completion date
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