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

NCT01296256 | Completed Phase 2

• 2 other identifiers: Benda-EAM2010-012010-020926-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Bendamustine; Conditioning Therapy; Autologous Stem Cell Transplant; Aggressive Non Hodgkin's Lymphoma

Keywords

Bendamustine; Conditioning Therapy; Autologous Stem Cell Transplant; Aggressive Non Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the progression free survival using techniques of image (PET and TC)of Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) as conditioning followed by ASCT in patients with aggressive lymphoma.

  18 months follow-up

Secondary Outcomes (1)

• Evaluate safety BeEAM chemotherapy followed of reinfusion of autologous hematopoietic stem cells by considering the incidence of adverse event (with CTCAE).Evaluate % patients in CR.Evaluate response of ASCT using PET, TC.Evaluate overall survival

  18 months follow-up

Study Arms (1)

Bendamustine-EAM

EXPERIMENTAL

Drug: Bendamustine-EAM

Interventions

Bendamustine-EAM DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients being able to meet all requirements of the clinical trial, according to the investigator's criteria,
• Patient giving voluntarily written informed consent before performing any essay test that is not part of routine care of patients.
• Age \>o=18 years and \>0=70 years
• Candidate for chemotherapy (QT) at high doses and ASCT
• Histologically confirmed aNHL:
• Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in sensitive relapse, so, in second complete or partial response, after a minimum of 2 cycles of the rescue regimen.
• Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in first complete or partial response, if more than one treatment line have been required to reach this first complete or partial response.
• Transformed B cell lymphoma in first CR
• Patients with PTCL (other than anaplastic ALK +) in first CR
• Performance status (ECOG) \<0=2.
• Adequate renal, hepatic, and bone marrow function (assessed \< 14 days before initiation of the study treatment):
• Neutrophil count \<o=1.5 x 109/L
• Platelet count \<o=100 x 109/L
• Haemoglobin \<o=8.0 g/dL
• Creatinine serum \>o=1,5 x ULN mg/dl

You may not qualify if:

• Impossibility of collecting, via apheresis, a number of CD34+ cells \>o=2 x 106/kg
• To receive any of the following treatments in the 28 days before the start the study treatment:
• i.chemotherapeutic or antitumor agents ii.radiation therapy, except in limited fields, to a maximum dose of \<o=10 Gy to control serious life-threatening symptoms iii.glucocorticoids, except doses equivalent to \<o=1 mg / kg of prednisolone / day with a duration \<o=7 days iv.any therapeutic agent under investigation.
• Known involvement of the central nervous system (CNS) by lymphoma
• Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders.
• Other serious or uncontrolled medical condition, such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease.
• Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation.
• Presence of any limitations that compromise the patient's ability to comply with the study treatment.
• Positive serology for HIV, HCV or HBV surface antigen (HBsAg). If the HBsAg is negative but anti-core antibodies (HBcAb) are positive and antibody against surface antigen (HBsAb) are negative, there will be a HBV DNA test; If positive results the patient may not be included in the trial. If both types of antibodies HBcAb and HBsAb are positive (indicative of past infection), the patient may be included in the study.
• Previous history of malignancies other than lymphoma (except basal cell or squamous cell skin carcinoma and carcinoma in situ of the cervix or breast) unless the patient is free of disease beyond 5 years.
• Major surgery procedure within 30 days prior to entering this study.
• Pregnant or nursing females.

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (21)

Complejo Hospitalario Universitario de Santiago

Santiago, A Coruña, 15706, Spain

Location

Hospital Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

H. de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

H. U. Marqués de Valdecilla.

Santander, Cantabria, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

H.U. 12 de Octubre,

Madrid, Madrid, Spain

Location

H.U. Gregorio Marañón,

Madrid, Madrid, Spain

Location

H.U. La Paz

Madrid, Madrid, Spain

Location

H.U. La Princesa

Madrid, Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Madrid, Spain

Location

Hospital Son Llátzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital Universitario Virgen de Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

H. Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Location

Hospital Clinico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

H. La Fe

Valencia, Valencia, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

Study Officials

• Mª Dolores Caballero, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Alejandro Martín, MD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Javier Briones, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• Juan Manuel Sancho, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Cristina Barrenetxea, MD

  Hospital Vall d'Hebrón

  PRINCIPAL INVESTIGATOR

• Javier López, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Mª José Rodríguez, MD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

• Jorge Gayoso, MD

  Gregorio Marañón Hospital

  PRINCIPAL INVESTIGATOR

• Miguel Ángel Canales, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Carlos Grande, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Isidro Jarque, MD

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• José Rifón, MD

  Clínica Universitaria Navarra

  PRINCIPAL INVESTIGATOR

• Andres Sánchez, MD

  Hospital Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

• Cristina Castilla, MD

  Hospital Morales Meseguer

  PRINCIPAL INVESTIGATOR

• José Luis Bello, MD

  Complejo Hospitalario Universitario de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Armando López, MD

  Hospial Clínic de Barcelona

  PRINCIPAL INVESTIGATOR

• Eulogio Conde, MD

  Hospital Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Reyes Arranz, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

• Encarnación Monzó, MD

  Hospital Arnau de Vilanova de Valencia

  PRINCIPAL INVESTIGATOR

• Rosario Varela, MD

  Complejo Hospitalario Universitario de A Coruña

  PRINCIPAL INVESTIGATOR

• Mª José Ramírez, MD

  Hospital Jerez de la Frontera

  PRINCIPAL INVESTIGATOR

• Fátima de la Cruz, MD

  Hospital Virgen del Rocío

  PRINCIPAL INVESTIGATOR

• Ana Pilar González, MD

  Hospital Central de Asturias

  PRINCIPAL INVESTIGATOR

• Luis Palomera, MD

  Hospital Clínico de Zaragoza "Lozano Blesa"

  PRINCIPAL INVESTIGATOR

• Raquel del Campo, MD

  Hospital Son Llátzer

  PRINCIPAL INVESTIGATOR

• Mª José Terol, MD

  Hospital Clínico de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2011
• First Posted: February 15, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ES (21)