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A Randomized Phase III Study To Evaluate Benefits Of Autologous Stem Cell Transplant In Patients With Peripheral T Cell Lymphoma That Achieved A First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.
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An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma (CA-4948 in NHL)
Jacksonville, Fla.,
Rochester, Minn.
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
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Cell, Serum, and Bone Marrow Bank for Patients receiving Chimeric Antigen Receptor T Cell Therapy or T cell engager therapy for the Treatment of Cancer
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to store blood, serum and bone marrow so that they can be used for laboratory studies that may contribute to finding the exact function of the CART cells or T-cell engager therapy such as bispecific and trispecific antibodies and the factors that may determine disease progression and treatment response.
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Empowerment Through Preparedness: Improving Advance Care Planning (ACP) In Adolescents And Young Adults (AYAs) With Advanced Solid Malignancies And High-Grade Brain Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This clinical trial studies whether educational tools work to improve early advance care planning (ACP) in adolescents and young adults (AYAs) with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and high-grade brain tumors. The incidence of AYA cancers is on the rise with approximately 90,000 new diagnoses yearly in the United States. Cancer remains the leading cause of disease-related death among AYAs, which could be due to patients having more advanced disease at presentation. It is recommended that AYAs begin ACP conversations at the start of treatment. ACP includes clarifying goals of care, discussions about end-of-life preferences, and completing a legal document that states the treatment or care a person wishes to receive or not receive if they become unable to make medical decisions (advance directive). The educational tools in this study include an early ACP educational video featuring AYAs with cancer and an ACP appointment geared for AYAs. Patients can access and watch the educational video at home prior to their scheduled ACP appointment. During the ACP appointment, a tailored ACP guide made specifically for AYAs is reviewed and questions regarding ACP are answered. This may help to introduce the importance of key ACP concepts, which may improve early ACP in AYAs with advanced solid tumors and high-grade brain tumors.
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A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and DC30+ Non-Hodgkin Lymphoma
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
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A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
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An Open-Label, First in Human, Phase 1/2 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and
Preliminary Efficacy of the CTPS1 Inhibitor STP938 in Adult Subjects with Relapsed/Refractory B-Cell and T-Cell
Lymphomas
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to evaluate the safety and tolerability of STP938 as a single agent in adult subjects with R/R B-cell and T-cell lymphomas.
Closed for Enrollment
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A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) (LOXO-BTK-18001)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma EPCORE™NHL-1
Scottsdale/Phoenix, Ariz.
The purpose of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose as well as to establish the safety profile of GEN3013 (DuoBody®-CD3xCD20) in patients with Relapsed, Progressive or Refractory B-Cell Lymphoma.
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A Phase 1b/2, Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma, With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this 3-part study, comprising a phase 1b dose escalation, dose expansion, and a phase 2, is to assess the safety, tolerability, dose-limiting toxicity(ies), maximum tolerated dose, and/or optimal biological dose, determine the recommended phase 2 dose, preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121.
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A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sezary Syndrome (SS)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
This phase I trial identifies the best dose, possible benefits, and/or side effects of duvelisib in combination with nivolumab in treating patients with stage IIB-IVB mycosis fungoides and Sezary syndrome. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib in combination with nivolumab may work better than giving each of these drugs individually, or treating with the usual approach in patients with mycosis fungoides and Sezary syndrome.
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A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) (CJBH492A12101)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this First-In-Human study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary effectiveness of JBH492 as single agent.
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A Randomized Phase 2 Study of CDX-1127 (Varlilumab) in Combination With Nivolumab in Patients With Relapsed or Refractory Aggressive B-Cell Lymphomas
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as varlilumab and nivolumab, may work by stimulating the immune system to attack cancer tumor cells.
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ACE-LY-308: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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ADCT-301-201 - A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the clinical effectiveness and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
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An Open-Label Phase 1/2 Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
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An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma (CA-4948 in NHL)
Scottsdale/Phoenix, Ariz.
This is a multi-center, open-label trial of orally administered CA-4948 monotherapy in adult patients with Relapsed or Refractory NHL. The trial will be conducted in 2 parts: an initial Dose Escalation Phase (Part A) of CA-4948 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma, (RR NHL) and a Dose Expansion Phase (Part B) of CA-4948 in patients with RR NHL with and without myeloid differentiation primary response 88 (MYD88) mutations. During Part B, patients will be enrolled regardless of MYD88 mutation status.
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An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY 1251152 in Patients With Advanced Cancer
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).
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DTRM-555_001, Phase II Expansion Cohorts Studies of a Novel Triple Combination Therapy, DTRM-555, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Non-Hodgkin’s Lymphomas
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the effectiveness of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
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Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.
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JCAR017-BCM-003 A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM). (TRANSFORM)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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JZP395-201: Prospective, Multicenter, Open-Label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Receiving Axicabtagene Ciloleucel (Yescarta®)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and effectiveness of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta®.
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MC1986 Phase I/Ib Study of Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
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