Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Aggression

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Mocetinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

MGCD0103

Gregory Reid, MSc, MBA

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with advanced solid tumors or Non-Hodgkin's Lymphoma.

Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Mirati Therapeutics Inc.

Gregory Reid, Chief Medical Officer

Nervous System Diseases

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Antineoplastic Agents

Anti-Infective Agents

Etoposide

Cytarabine

Bendamustine Hydrochloride

Melphalan

Etoposide phosphate

Antineoplastic Agents, Alkylating

Alkylating Agents

Bendamustine 200 mg/m2 starting dose on day -7 and -6 Etoposide 200 mg/m2 from day -5 to day -2 Ara-C 400 mg/m2 from day -5 to day -2 Melphalan 140 mg/m2 on day -1

Bendamustine-EAM

Mª Dolores Caballero, MD

Alejandro Martín, MD

Javier Briones, MD

Juan Manuel Sancho, MD

Cristina Barrenetxea, MD

Javier López, MD

Mª José Rodríguez, MD

Jorge Gayoso, MD

Miguel Ángel Canales, MD

Carlos Grande, MD

Isidro Jarque, MD

José Rifón, MD

Andres Sánchez, MD

Cristina Castilla, MD

José Luis Bello, MD

Armando López, MD

Eulogio Conde, MD

Reyes Arranz, MD

Encarnación Monzó, MD

Rosario Varela, MD

Mª José Ramírez, MD

Fátima de la Cruz, MD

Ana Pilar González, MD

Luis Palomera, MD

Raquel del Campo, MD

Mª José Terol, MD

The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma.

BCNU (carmustine is a nitrosurea alkylating agent used for many years in the conditioning of patients with lymphoma however this drug is hardly available in some countries in Europe, moreover to improve conditioning regimens in autologous stem cell transplant is important because the anti-tumoral effect of high dose therapy are responsible for this procedure efficacy. Although for many years few advances have been achieved in this area now new drugs can be tested in these patients.

Bendamustine is a unique cytotoxic agent with structural similarities to alkylating agents and antimetabolites, but which is non-cross-resistant with alkylating agents and other drugs in vitro and in the clinic. Early clinical studies conducted in the German Democratic Republic more than 30 years ago suggested promising activity in indolent non-Hodgkin's lymphoma (NHL). Two North American trials reported responses in more than 70% of patients with chemotherapy- and rituximab-refractory disease, suggesting that bendamustine may be the most effective drug available for this patient population. Response rates of 90% to 92%, with complete remission in 55% to 60%, have been reported in patients with follicular and mantle-cell lymphoma with the combination of bendamustine and rituximab.(Cheson 2009) Leone et all have recently reported results on the characterization of the mechanisms of action of bendamustine and its comparison with structurally related compounds as chlorambucil and phosphoramide mustard have demonstrated that bendamustine displays a distinct mechanisms of action including activation of DNA-damage stress response and apoptosis, inhibition of mitotic checkpoints, and induction of mitotic catastrophe. Also bendamustine activates a base excision DNA repair pathway rather than an alkyltransferase DNA repair mechanism.

These data suggest that bendamustine possesses mechanistic features that differentiate it from other alkylating agents and makes this old new drug an attractive one to combine with other agents in the conditioning transplant setting (Leone 2008).

Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).

Bendamustine, Cytarabine, Etoposide and Melphalan as Conditioning for Autologous Stem Cell Transplant in Patients With Aggressive Non Hodgkin's Lymphoma.

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma	NCT00323934	Tumors Non Hodgkin's L...	MGCD0103	18 Years -	Mirati Therapeutics Inc.
Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).	NCT01296256	Bendamustine Conditioning Th... Autologous Stem... Aggressive Non ...	Bendamustine-EA...	18 Years - 70 Years	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Spots Global Cancer Trial Database for aggressive non hodgkin's lymphoma