Neoplasms

Blood and Lymph Conditions

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Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

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Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Tipifarnib

Bridget Martell, MD

Phase II study designed to investigate antitumor activity in terms of objective response rate (ORR) of tipifarnib subjects with advanced Peripheral T-Cell Lymphoma (PTCL). Tipifarnib will be administered orally until disease progression.

This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with relapsed or refractory PTCL. The first 18 subjects may be of the following PTCL sub-types: PTCL not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive and negative anaplastic large cell lymphoma (ALCL), hepatosplenic T-cell lymphoma, enteropathy-associate T-cell lymphoma (EATL), extranodal natural killer (NK) T-cell lymphoma, nasal type and subcutaneous panniculitis-like T-cell lymphoma. The AITL expansion cohort (N=32) will enroll only subjects with AITL. An additional cohort of patients (N=12) expressing the wild type CXCL12 3' UTR will be enrolled in order to explore the benefits of tipifarnib treatment observed in patients having an absence of this gene variation or single nucleotide variation (SNV).

Tumor response assessments will be conducted according to Lugano Classification and/or mSWAT criteria.

Tumor assessments will be performed approximately every 8 weeks (cycles 2-6) and at least once approximately every 12 weeks thereafter (Cycles 9, 12, 15, etc.), and will continue until disease progression. Subjects experiencing a complete response may be considered for bone marrow transplantation. Upon disease progression, all subjects will be followed for survival and the use of subsequent therapy. All subjects will be followed for safety during treatment and up to approximately 30 days after treatment discontinuation or until before the initiation of another anti-cancer therapy. Additional follow up may be implemented until the subject recovers from any emergent treatment related toxicity or the adverse event is considered irreversible by the investigator.

Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.

An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma

Response assessments according to Lugano Classification and/or mSWAT

To determine the antitumor activity in terms of PFS in subjects with relapsed/refractory PTCL

To determine the antitumor activity in terms of DOR in subjects with relapsed/refractory PTCL

To evaluate the safety and tolerability of tipifarnib in subjects with relapsed/refractory PTCL

Kura Oncology, Inc.

Lymphoma, Large-Cell, Anaplastic

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Vincristine

Prednisolone

Lenalidomide

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle

Li Wang, M.D., Ph.D.

Wei Xu, M.D., Ph.D.

Li Wang, M.D., Ph.D

Wei Xu, M.D., Ph.D

The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.

Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

overall response rate after treated by lenalidomide-CHOP regimen

from date of inclusion to date of progression, relapse, or death from any cause

from the date of inclusion to date of death, irrespective of cause

The First Affiliated Hospital with Nanjing Medical University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.	NCT02464228	Relapsed or Ref...	Tipifarnib	18 Years -	Kura Oncology, Inc.
Lenalidomide in Combination With CHOP in Patients With Untreated PTCL	NCT04423926	PTCL, NOS AITL ALK- ALCL Phase III-IV AL... EATL	Lenalidomide Cyclophosphamid... Doxorubicin Vincristine Prednisolone	18 Years - 70 Years	The First Affiliated Hospital with Nanjing Medical University
Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.	NCT02464228	Relapsed or Ref...	Tipifarnib	18 Years -	Kura Oncology, Inc.

Spots Global Cancer Trial Database for eatl

Every month we try and update this database with for eatl cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for eatl

Every month we try and update this database with for eatl 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 eatl 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.