cyclophosphamide intravenous / Generic mfg. - LARVOL DELTA

[VIRTUAL] Phase I clinical trial evaluating the safety of ADP-A2M10 in patients with MAGE-A10+ head and neck, melanoma, or urothelial tumors (SITC 2020) - P1 | "Eligible pts underwent lymphodepletion with fludarabine and cyclophosphamide prior to receiving ADP-A2M10. Given the minimal antitumor activity and the discovery that MAGE-A10 expression frequently overlaps with MAGE-A4 expression, the clinical program has closed. Several trials with SPEAR T-cells targeting MAGE-A4 are ongoing (https://bit.ly/35htsZK)."

Clinical • IO biomarker • P1 data • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • MAGEA4

[VIRTUAL] Phase I clinical trial evaluating the safety of ADP-A2M10 SPEAR T-cells in patients with MAGE-A10+ advanced non-small cell lung cancer (SITC 2020) - P1 | "Pts underwent lymphodepletion (LD) with varying doses/schedules of fludarabine (Flu) and cyclophosphamide (Cy) prior to receiving ADP-A2M10. Given the minimal antitumor activity and the discovery that MAGE-A10 expression frequently overlaps with MAGE-A4 expression, the clinical program has closed. Several trials with SPEAR T-cells targeting MAGE-A4 are ongoing (https://bit.ly/35htsZK)."

Clinical • IO biomarker • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MAGEA4

Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Northside Hospital, Inc.; Trial completion date: Aug 2023 ➔ Aug 2026; Trial primary completion date: Aug 2022 ➔ Aug 2025

Clinical • Trial completion date • Trial primary completion date • Anemia • Aplastic Anemia • Hematological Disorders • Transplantation

ACCESS: HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (clinicaltrials.gov) - P2; N=180; Not yet recruiting; Sponsor: Center for International Blood and Marrow Transplant Research

Clinical • New P2 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-DRB1

ACCESS: HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (clinicaltrials.gov) - P2; N=180; Recruiting; Sponsor: Center for International Blood and Marrow Transplant Research; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-DRB1

Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. (PubMed, J Clin Oncol) - P3 | "In the 50303 study population, the more intensive, infusional DA-EPOCH-R was more toxic and did not improve PFS or OS compared with R-CHOP. The more favorable results with R-CHOP compared with historical controls suggest a potential patient selection bias and may preclude generalizability of results to specific risk subgroups."

Clinical • Clinical data • Journal • P3 data • Diffuse Large B Cell Lymphoma • Gene Therapies • Hematological Disorders • Hematological Malignancies • Immunology • Lymphoma • Mucositis • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain

Brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as frontline treatment for patients with CD30-positive B-cell lymphomas. (PubMed, Haematologica) - P1/2 | "In the PMBCL cohort, 2-year PFS was 86% (95% CI: 62-95). In summary, BV-R-CHP with or without consolidative radiation is a feasible and active frontline regimen for CD30+ B-cell lymphomas (NCT01994850)."

Clinical • Combination therapy • Journal • Diffuse Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. (PubMed, J Clin Oncol) - P3 | "The excellent results of R-CHOP followed by rituximab maintenance until progression for older patients with MCL persisted in a mature follow-up. Prolongation of rituximab maintenance beyond 2 years is effective and safe."

Clinical • Journal • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Mantle Cell Lymphoma • Oncology

Third-generation anti-CD19 chimeric antigen receptor T-cells incorporating a TLR2 domain for relapsed or refractory B-cell lymphoma: a phase I clinical trial protocol (ENABLE). (PubMed, BMJ Open) - P1; "Following WZTL-002 manufacture and product release, participants will receive lymphodepleting chemotherapy comprising intravenous fludarabine and cyclophosphamide. Trial results will be reported in a peer-reviewed journal, and results presented at scientific conferences or meetings. NCT04049513."

CAR T-Cell Therapy • Clinical • Journal • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD8

Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. (PubMed, J Clin Oncol) - "Conclusion The addition of VI to VAC did not improve EFS or OS for patients with intermediate-risk RMS. VAC/VI had less hematologic toxicity and a lower cumulative cyclophosphamide dose, making VAC/VI an alternative standard therapy for intermediate-risk RMS."

Clinical • Journal • Sarcoma

[VIRTUAL] SYSTEMATIC LITERATURE REVIEW AND NETWORK META-ANALYSIS COMPARING THERAPIES FOR TREATMENT-NAÏVE PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (EHA 2020) - "Background Venetoclax (Venclexta, Ven) in combination with obinutuzumab (Gazyva, G) is a novel treatment regimen for treatment-naïve (TN) patients with chronic lymphocytic leukemia (CLL). The CLL14 study provided direct evidence on the efficacy versus chlorambucil (Clb) plus G, however there is an absence of head-to-head clinical evidence on the comparative efficacy of novel targeted therapies in the TN setting. Aims To assess the relative efficacy of VEN+G compared to G+Clb, Clb monotherapy; ibrutinib plus G (Ibr+G); ibrutinib plus rituximab (Ibr+R); ibrutinib monotherapy (Ibr); bendamustine plus rituximab (B+R); Clb+R; ofatumumab (O) plus Clb (O+Clb); and fludarabine, cyclophosphamide and R (FCR) in TN-CLL patients...In the scenario analysis, VEN+G showed benefit in PFS versus FCR. Future comparisons with more mature data across trials will provide more robust estimates of overall survival comparisons."

Retrospective data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

[VIRTUAL] Efficacy of Four Drug Regimens in Multiple Myeloma: A Systemic Review (ASH 2020) - "(2019) studied the efficacy of daratumumab (D), bortezomib (V), thalidomide (T) and dexamethasone (d) vs VTd in NDMM patients (pts) (n=1085) in CASSIOPEIA trial...(2018) reported the role of DV + melphalan (M) + prednisone (P) vs VMP in NDMM pts (n=706) (ALCYONE trial)...(2017) studied the role of DVd + cyclophosphamide (C) in pts with NDMM (n=86) and RRMM (n=14) with ORR of 81.4% (95% CI, 71.6-89.0%) and 71.4% (95% CI, 41.9-91.6%) respectively for NDMM and RRMM...(2014) studied siltuximab (S) +VMP vs. VMP in NDMM pts (n=98) with ORR of 88% (95% CI 75%, 95%) in SVMP and 80% (95% CI 66%, 90%) in VMP and PFS of 88% in both arms; though median survival and overall survival were not reached in either arm despite a median follow-up of 23.3 months & 21.9 mo respectively...(2017) studied the role of elotuzumab (E) + Lenalidomide (R) + VP in NDMM pts (n=41 with ORR of 100%)...(2015) studied the role of Carfilzomib (K) + CTd in NDMM pts (n=64) with ORR of 91% and median PFS..."

Clinical • Review • Fatigue • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Transplantation

[VIRTUAL] KarMMa-3: A Phase 3 Study of Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy Vs Standard Regimens in Relapsed and Refractory Multiple Myeloma (ASH 2020) - P3 | "STUDY DESIGN: Patients with RRMM who had received 2-4 prior regimens (including ≥ 2 consecutive cycles of daratumumab [DARA], an immunomodulatory agent, and a PI [individually or in combinations]) are randomized 2:1 to receive ide-cel or one of the following standard regimens based on the patient’s most recent regimen and investigator discretion: DARA + pomalidomide (POM) + dexamethasone (DEX; DPd), DARA + bortezomib + DEX (DVd), ixazomib + lenalidomide + DEX (IRd), carfilzomib + DEX (Kd), or elotuzumab + POM + DEX (EPd)...Ide-cel is manufactured following leukapheresis and then infused (at dose levels from 150 to 450 × 106, but targeting 450 × 106, CAR+ T cells) after 2 days of rest following lymphodepletion with 3 days of fludarabine 30 mg/m2 + cyclophosphamide 300 mg/m2...Immunogenicity and biomarkers are exploratory endpoints. KarMMa-3 is registered at ClinicalTrials.gov: NCT03651128."

CAR T-Cell Therapy • IO biomarker • P3 data • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology • Transplantation • CD38

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: Roswell Park Cancer Institute; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Fallopian Tube Cancer • Germ Cell Tumors • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial completion date: Aug 2020 ➔ Dec 2021; Trial primary completion date: Feb 2020 ➔ Dec 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Germ Cell Tumors • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial primary completion date: Nov 2019 ➔ Feb 2020

Clinical • Combination therapy • Trial primary completion date • Fallopian Tube Cancer • Germ Cell Tumors • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Roswell Park Cancer Institute; Trial primary completion date: Aug 2019 ➔ Nov 2019

Clinical • Combination therapy • Trial primary completion date • Fallopian Tube Cancer • Germ Cell Tumors • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Roswell Park Cancer Institute; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Fallopian Tube Cancer • Germ Cell Tumors • Ovarian Cancer • Peritoneal Cancer • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Roswell Park Cancer Institute

Clinical • Combination therapy • New P1 trial • Fallopian Tube Cancer • Germ Cell Tumors • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: Roswell Park Cancer Institute; Trial completion date: Dec 2021 ➔ Mar 2032; Trial primary completion date: Dec 2020 ➔ Mar 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Germ Cell Tumors • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CTAG1B

Pre-op Pembro + Radiation Therapy in Breast Cancer (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Alice Ho; Not yet recruiting ➔ Recruiting; Initiation date: Aug 2020 ➔ Jul 2021

Clinical • Enrollment open • IO biomarker • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • ER • FOXP3 • HER-2 • PD-L1 • PGR

Pre-op Pembro + Radiation Therapy in Breast Cancer (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Alice Ho

Clinical • IO biomarker • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • ER • FOXP3 • HER-2 • PD-L1 • PGR

SIGNIFICANT ARI-0001 (A3B1:CD8:4-1BB:CD3Z CAR19) CELL EXPANSION IN A PATIENT WITH REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA THROUGH PRE-LYMPHOAPHERESIS IBRUTINIB ADMINISTRATION. (EHA 2018) - P1; "Methods A 53-year-old female diagnosed with CLL was referred to us after treatment with fludarabine, cyclophosphamide and rituximab, rituximab plus bendamustine, ibrutinib, idelalisib, obinutuzumab and venetoclax. This case of significant ARI-0001 cell proliferation is consistent with what has been observed with tisagenlecleucel and other emerging pre-clinical data. Preliminary data may suggest that ibrutinib, even when given in a short period of time (2 weeks), could improve ARI-0001 performance in this disease."

Clinical • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Indolent Lymphoma

Update in Systemic Treatment of SCLC (IASLC-WCLC 2019) - "Chemotherapy combination of cisplatin plus etoposide is the standard option for extensive stage Small Cell Lung Cancer (SCLC); though the response rate was very high, however most cases of the extensive stage recurred within one year and there was no good regimen for second line. Several chemotherapeutic agents such as topotecan, irinotecan, amrubicin or combination of cyclophosphamide, doxorubicin and vincristine (CAV) had been used as second line treatment with minimal benefit.Within the past couple years there’re the new way of treating lung cancer especially the use of immunotherapy, which several agents had their roles in the treatment of Non-Small Cell Lung Cancer (NSCLC)...The use of T cell immune-checkpoint inhibitors (anti-PD1: nivolumab, pembrolizumab; anti-PD-L1: atezolizumab, durvalumab; anti-CTLA-4: ipilimumab, tremelimumab) have shown promising antitumor activity with the potential to prolong survival in SCLC patients.Nivolumab was the first immunotherapy..."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Con - Raphael Bueno Is Right (It Does Not Work) (IASLC-WCLC 2019) - P1, P2, P2/3, P3; "...Combination chemotherapy with platinum/antifolate –either pemetrexed or raltitrexed- is the only standard of care 1st line treatment with proven improvement of survival, which varies according to series and patient selection between 12-16 months median overall survival (mOS), with corresponding 1 year survival rate of 50-60%...The randomized DETERMINE trial evaluated in 564 patients the anti–CTLA-4 antibody tremelimumab versus placebo in second or third line and found no benefit in outcome (hazard ratio 0.92; p = 0.408). Results from the anti–PD-1 or anti–PD-L1 trials with nivolumab, pembrolizumab and durvalumab are fairly consistent with a response rate of 19-30%, a median PFS of 3.5 – 6.0 months and mOS of 12-18 m, all uncontrolled in selected patients with good prognostic features...The DREAM trial, a single-arm, open-label phase II trial of durvalumab with cisplatin/pemetrexed, followed by durvalumab maintenance therapy for 1 year...The phase III CheckMat

IO biomarker • PD(L)-1 Biomarker • Tumor mutational burden • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Thoracic Cancer