Neoplasms

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All Conditions

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Symptoms and General Pathology

Rare Diseases

Leukemia

Lymphoma

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Neoplasms, Plasma Cell

Lymphoma, Non-Hodgkin

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, B-Cell

Hematologic Diseases

Waldenstrom Macroglobulinemia

Leukemia, Lymphoid

Neoplasms by Histologic Type

Lymphoproliferative Disorders

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Leukemia, B-Cell

Chronic Disease

Disease Attributes

B-cell Lymphoma

Chronic Graft Versus Host Disease

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Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

All Drugs and Chemicals

Amino Acids

Pirtobrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

LOXO-338 administered orally in combination with pirtobrutinib

LOXO-338

James Pauff, MD; PhD

The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.

This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, part 2 will evaluate the combination of LOXO-338 with the highly selective, noncovalent Bruton's tyrosine kinase (BTK) inhibitor, pirtobrutinib (LOXO-305).

Study of Oral LOXO-338 in Patients With Advanced Blood Cancers

A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies

Measured by the number of patients with dose-limiting toxicities (DLTs)

Measured by the appropriate disease specified response criteria as appropriate to tumor type

PK: AUC of LOXO-338 alone and in combination with pirtobrutinib

PK: Cmax of LOXO-338 alone and in combination with pirtobrutinib

Loxo Oncology, Inc.

Eli Lilly and Company

Syndrome

In the U.S., physicians seeking help on behalf of their patients may contact Lilly at

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Antineoplastic Agents

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Bendamustine plus rituximab administered intravenously (IV)

Bendamustine

Alex Levy, MD

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Eligible patients will be randomized 1:1 into Arm A and Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

Assessments of effectiveness include PFS, assessed by investigator

Assessments of effectiveness include OS, assessed by investigator

Assessments of effectiveness include TTNT, assessed by investigator

Assessments of effectiveness include ORR, assessed by investigator and IRC

Assessments of effectiveness include DOR, assessed by investigator and IRC

Based on time to worsening of CLL/SLL-related symptoms

Based on time to worsening of physical functioning

Richter Syndrome

Investigating VIP152 in a monotherapy cohort in patients with high-risk CLL and Richter Syndrome

Investigating VIP152 in combination with a BTKi in patients with CLL

VIP152

BTKi

Vincerx Study Director

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 as monotherapy or in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

An Open-label, Multicenter Phase 1/1b Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP152 Monotherapy or Combination Therapy in Subjects With High-risk Chronic Lymphocytic Leukemia or Richter Syndrome

Number of participants with adverse events as a measure safety and tolerability of high risk CLL and RS in monotherapy

Tumor response evaluation based on the response criteria as applicable for CLL and Richter Syndrome

Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per applicable response criteria

Number of Participants Without Disease Progression per iwCLL guidelines for CLL \& Lugano Classification for NHL

Maximum observed drug concentration in measured administration (Cmax) of VIP152

time from first dose to the initiation of next dose or death

Vincerx Pharma, Inc.

Venetoclax

Fixed duration pirtobrutinib in combination with venetoclax and rituximab

Patient Advocacy

Jose Leis

Abhijeet Kumar

Catherine Coombs

Marin Xavier

Eliana Kozin

Jarrod Holmes

Kwok Ming Lo

Liliana Bustamante

Ayed Ayed

Gustavo Fonseca

Viralkumar Bhanderi

Shachar Peles

Vamsi Vasireddy

Audrik Leticia Perez Rodriguez

Christopher Croot

Michael Castine

Bruce Cheson

Matthew Davids

Yasmin Karimi

Suresh Balasubramanian

Yucai Wang

Leonid Shunyakov

Suman Kambhampati

Anthony Mato

Lori Ann Leslie

Charles Farber

Nicole Lamanna

Lindsey Roeker

Suchitra Sundaram

Delong Liu

Bernard Poiesz

Ryan Jacobs

Alan Skarbnik

Andrea Sitlinger

Jennifer Woyach

Bertrand Anz

Ian Flinn

Shilpan Shah

Alessandra Ferrajoli

Christal Murray

Emily Ayers

Victor Yazbeck

Nadia Khan

Brett Gourley

Timothy Wassenaar

Anish Puliyayil

Emma Verner

Uwe Hahn

Joanna Czerwinski

Anna Johnston

Masa Lasica

Patricia Walker

Constantine Tam

Allison Barraclough

Gavin Cull

Fritz Offner

Vanessa Delrieu

Helen Vellemans

Sarah Perry

Carolyn Owen

Russell Sterrett

Alina Gerrie

Versha Banerji

David Spaner

Tanya Skamene

Ruixiang Xia

Yujun Dong

Yu Yang

Chuan Jin

Ziwen Guo

Hong Cen

Xiaoli Yuan

Xiaoxi Zhou

Guohui Cui

Jingming Guo

Hongling Peng

Junjun Li

Da Gao

Xiaohong Xu

Xin zhou

Yuerong Shuang

Wei Yang

Jianyong Li

Hongwei Xue

Ligen Liu

Junmin Li

Lihua Qiu

Keqian Shi

Jie Jin

Ying Xiang

Jiri Mayer

Martin Simkovic

Heidi Mocikova

Marek Trneny

Caspar da Cunha-Bang

James Pauff, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers	NCT05024045	Leukemia, Lymph... Lymphoma, B-cel... Lymphoma, Non-H... Multiple Myelom... B-cell Lymphoma Waldenstrom Mac... Lymphoma, Mantl...	LOXO-338 Pirtobrutinib	18 Years -	Eli Lilly and Company
Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer	NCT05172700	Leukemia, Lymph... Lymphoma, Lymph... Lymphoma, Mantl... Waldenstrom Mac... Ritcher's Trans...	Pirtobrutinib	18 Years -	Eli Lilly and Company
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)	NCT05023980	Chronic Lymphoc... Small Lymphocyt...	Pirtobrutinib Bendamustine Rituximab	18 Years -	Eli Lilly and Company
A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome	NCT04978779	Relapsed Non Ho... Chronic Lymphoc... Refractory Chro... Richter Syndrom... MYC Amplificati... MYC Overexpress... MYC Translocati...	VIP152 BTKi	18 Years -	Vincerx Pharma, Inc.
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)	NCT04965493	Chronic Lymphoc... Small Lymphocyt...	Pirtobrutinib Venetoclax Rituximab	18 Years -	Eli Lilly and Company
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)	NCT05254743	Chronic Lymphoc... Leukemia, Lymph... Leukemia, B-cel... Small Lymphocyt...	Pirtobrutinib Ibrutinib	18 Years -	Eli Lilly and Company
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)	NCT05023980	Chronic Lymphoc... Small Lymphocyt...	Pirtobrutinib Bendamustine Rituximab	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for btki

Every month we try and update this database with for btki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for btki

Every month we try and update this database with for btki cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for btki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.