Campath (alemtuzumab)

P1, N=18, Active, not recruiting, University of Alberta | Trial completion date: Oct 2024 --> Jan 2025

P2/3, N=38, Completed, Columbia University | Unknown status --> Completed

P=N/A, N=50, Recruiting, French Innovative Leukemia Organisation | Trial primary completion date: Jun 2023 --> Jun 2025

P1, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2024 | Trial primary completion date: Dec 2026 --> Sep 2024

For rapidly progressive or interleukin-6 abnormally elevated steroid-refractory IRM, alemtuzumab or tocilizumab/tofacitinib are the preferred therapeutic agents, respectively. For steroid-refractory IRM comorbid with myositis or comorbid with myasthenia gravis, abatacept + ruxolitinib/mycophenolate mofetil (MMF)/intravenous immunoglobulin (IVIG), or MMF + pyridostigmine/IVIG are the preferred therapeutic agents, respectively. The pathogenesis of steroid-refractory IRM and the treatment regimen remain unclear. A large number of studies need to be conducted to validate or update our proposed treatment approach.

P2, N=40, Active, not recruiting, Boston Children's Hospital | Trial primary completion date: Apr 2024 --> Dec 2024

P1/2, N=40, Recruiting, Cellectis S.A. | Trial primary completion date: Dec 2023 --> Jan 2026

We present a patient diagnosed with T-PLL with MTCP1 rearrangement who was successfully treated with alemtuzumab followed by consolidative allogeneic unrelated donor stem cell transplantation...However, the lymphoma cells were clonally related to those at presentation. Currently, literature on T-PLL-like cases lacking the rearrangement of TCL1A is limited, and the possibility of whether a proportion of such cases could represent PTCL, NOS (with leukemic involvement) needs consideration.

P2, N=40, Suspended, St. Jude Children's Research Hospital | Trial completion date: Jul 2025 --> Aug 2027 | Trial primary completion date: Jul 2024 --> Aug 2026

P1, N=18, Active, not recruiting, University of Alberta | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Aug 2022 --> Aug 2024

P=N/A, N=57, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2025 --> Aug 2024

P1/2, N=45, Active, not recruiting, University of Illinois at Chicago | Recruiting --> Active, not recruiting | N=15 --> 45

P1/2, N=22, Completed, University of Alberta | Active, not recruiting --> Completed | N=60 --> 22 | Trial completion date: Dec 2025 --> Jul 2024

Current treatments, i.e. the CD52-antibody alemtuzumab, offer transient responses, with relapses being almost inevitable without consolidating allogeneic transplantation...Overall, the most efficient/selective single-agents and combinations (in vitro and in mice) in-cluded Cladribine, Romidepsin ((H)DAC), Venetoclax (BCL2), and/or Idasanutlin (MDM2)...Our data emphasize the therapeutic potential of pharmacologic strategies to reinstate P53-mediated apoptotic responses. The identified efficacies and their synergies provide an informative background on compound and patient selection for trial designs in T-PLL.

P1, N=20, Recruiting, City of Hope Medical Center | Trial completion date: Oct 2028 --> Dec 2026 | Trial primary completion date: Oct 2028 --> Dec 2026

P2, N=53, Active, not recruiting, Columbia University | Trial completion date: Dec 2023 --> Feb 2025 | Trial primary completion date: Dec 2023 --> Feb 2025

P2, N=6, Active, not recruiting, Ohio State University Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=25 --> 6 | Trial primary completion date: Dec 2024 --> Apr 2024

P2, N=20, Not yet recruiting, Case Comprehensive Cancer Center | Initiation date: Apr 2024 --> Oct 2024

P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026

P1/2, N=15, Recruiting, University of Illinois at Chicago | Trial primary completion date: Jan 2024 --> Jan 2025

However, increased infections and relapse resulted in a lack of survival benefit after long-term follow-up. ClinicalTrials.gov identifier: NCT00520130.

This study of ex vivo T-cell depleted SCT's demonstrates that NK cells recover quicker when compared to those receiving unfractionated grafts. These results may have implications for GvHD and the GvL effect which warrants further study.

P2, N=12, Recruiting, Children's National Research Institute

P2, N=53, Active, not recruiting, Northwestern University | Trial completion date: May 2023 --> May 2027

P1/2, N=130, Active, not recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Jan 2026

P2, N=75, Active, not recruiting, Children's Hospital of Philadelphia | Recruiting --> Active, not recruiting

P=N/A, N=25, Recruiting, Erasmus Medical Center | Not yet recruiting --> Recruiting

P2, N=25, Recruiting, Ohio State University Comprehensive Cancer Center | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=162, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Dec 2024 --> Dec 2023

P2, N=40, Active, not recruiting, Boston Children's Hospital | Trial primary completion date: Jan 2024 --> Apr 2024

Abnormal cells in BM and PB became undetectable on microscopy and FCM, and the CNS lesion disappeared on MRI after second-line therapy with alemtuzumab...Allogeneic hematopoietic stem-cell transplantation was performed, and the fusion mRNA has now been undetectable for more than 5 years since transplantation. This is the first report of a T-PLL case with a CLEC16A::IL2 fusion gene.

P=N/A, N=30, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025

P=N/A, N=50, Recruiting, Masonic Cancer Center, University of Minnesota | Trial primary completion date: Jul 2024 --> Jul 2025 | Trial completion date: Jul 2024 --> Jul 2026

P2, N=162, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

There is currently moderate- to very low-certainty evidence available regarding the benefits and harms of maintenance therapy in people with CLL. Anti-CD20 mAbs maintenance improved PFS, but also increased grade 3/4 AEs and all AEs. IMiD maintenance had a large effect on PFS, but also increased grade 3/4 AEs. However, none of the above-mentioned maintenance interventions show differences in OS between the maintenance and control groups. The effects of alemtuzumab maintenance are uncertain, coupled with a warning for drug-related infectious toxicity. We found no studies evaluating other novel maintenance interventions, such as B-cell receptor inhibitors, B-cell leukaemia-2/lymphoma-2 inhibitors, or obinutuzumab.

P1/2, N=72, Recruiting, National Heart, Lung, and Blood Institute (NHLBI) | Not yet recruiting --> Recruiting

P2, N=22, Completed, Randy Windreich | Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Apr 2023 | Trial primary completion date: Nov 2023 --> Apr 2023

P2, N=30, Recruiting, Robert Nickel | Trial primary completion date: Dec 2024 --> Nov 2025

P1, N=18, Not yet recruiting, Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Approaches to prevent GVHD include pharmacologic strategies such as calcineurin inhibitors (cyclosporine, tacrolimus) combined with methotrexate or mTOR inhibitors (sirolimus), and IMP dehydrogenase inhibitors (mycophenolate mofetil). Increasingly, posttransplant cyclophosphamide is emerging as a promising strategy for GVCHD prevention especially in a setting of reduced intensity conditioning. Other approaches include serotherapy (ATG, Campath) and graft manipulation strategies...Targeted therapies including Bruton's tyrosine kinase inhibition, JAK1/2 inhibition, and ROCK2 inhibitors have improved cGVHD therapy, especially in the steroid refractory setting. Continued improvement in prophylactic strategies for cGVHD, identification of accurate cGVHD treatment endpoints, and access to novel therapeutic agents are expected to improve cGVHD outcomes.

Conditioning was myeloablative busulfan with pharmacokinetic monitoring and fludarabine +/- cyclophosphamide/thiotepa or a reduced intensity melphalan-based regimen with fludarabine. All patients received serotherapy with ATG or alemtuzumab. Post-PSCT immune suppression was none or mycophenolate mofetil (MMF) and/or a calcineurin inhibitor (CNI)... 41 patients with a variety of IEIs were included (Figure 1). At a median follow-up of 2.5 years, OS was 85% (95% CI 75-97%) and EFS 80% (95% CI 69-94%), but was variable by underlying disease (Figure 2). Three patients experienced graft failure (7.3%), two requiring a second transplant and one receiving donor lymphocyte infusion only.

P2, N=12, Recruiting, University of Calgary | Trial completion date: Jul 2024 --> Jul 2028 | Trial primary completion date: Jul 2023 --> Jul 2028