Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

NCT01361191 | Completed Phase 2 DMC

• 2 other identifiers: GEL/TAMO-2006EudraCT number 2006-005254-68
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 19

Brief Summary

The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.

Conditions

Diffuse Large B-cell Lymphoma; Follicular Grade 3B Lymphoma

Keywords

DLBCL; PET; IPI; R-MegaCHOP; Autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH

  5 years follow-up

Secondary Outcomes (1)

• To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.

  5 years follow-up

Interventions

R-MEGACHOP DRUG

* If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT * If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5 R-IFE: 2 cycles every 21 days: IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3. ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3).

Eligibility Criteria

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

You may qualify if:

• follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
• aged between 18 and 65 years. Patients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbidity.
• IPI adjusted to the age over 1 or a-IPI and beta2-microglobulin equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4
• Life expectancy over 12 weeks
• Written informed consent form 6. New diagnosed patient without any previous treatment

You may not qualify if:

• Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
• uncontrolled high blood pressure (diastolic pressure in rest \> 115 mmHg)
• Altered hepatic function (bilirubin or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (creatinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma.
• other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
• patients positive for HIV
• patients with transformed follicular lymphoma
• pregnant women or in nursing; women of childbearing age who do not use an adequate contraceptive method before being included in the study
• ventricular ejection fraction inferior to 50%
• patients with severe psychiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)

Sponsors & Collaborators

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

Study Sites (19)

ICO- Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Clínico Univ. de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Jaén, 23006, Spain

Location

Hospital Universitario La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Univ. Son Dureta

Palma de Mallorca, Mallorca, 07014, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital Univ. Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

Hospital General de Segovia

Segovia, Segovia, 40002, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47010, Spain

Location

Hospital Universitario Virgen de la Concha

Zamora, Zamora, 49022, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• José Fuster, MD

  Son Dureta Hospital

  PRINCIPAL INVESTIGATOR

• Carlos Grande, MD

  12 Octubre Hospital

  PRINCIPAL INVESTIGATOR

• José Luís Bello, MD

  Santiago Hospital

  PRINCIPAL INVESTIGATOR

• Maria José Ramirez, MD

  Jerez Hospital

  PRINCIPAL INVESTIGATOR

• Carlos Panizo, MD

  Navarra Clinic

  PRINCIPAL INVESTIGATOR

• Elena Pérez, MD

  Morales i Meseguer Hospital

  PRINCIPAL INVESTIGATOR

• Jorge Gayoso, MD

  Gregorio Marañon Hospital

  PRINCIPAL INVESTIGATOR

• Reyes Arranz, MD

  Princesa Hospital

  PRINCIPAL INVESTIGATOR

• Eulogio Conde, MD

  Marques de Valdecilla Hospital

  PRINCIPAL INVESTIGATOR

• Eva González, MD

  Duran i Reynals Hospital

  PRINCIPAL INVESTIGATOR

• Miguel Canales, MD

  La Paz Hospital

  PRINCIPAL INVESTIGATOR

• Joan Bargay, MD

  Son Llatzer Hospital

  PRINCIPAL INVESTIGATOR

• Miguel T. Hernández, MD

  Canarias University Hospital

  PRINCIPAL INVESTIGATOR

• Antonio Alcala, MD

  Jaen Hospital

  PRINCIPAL INVESTIGATOR

• Luis Palomera, MD

  Lozano Blesa Clinic

  PRINCIPAL INVESTIGATOR

• José Queizán, MD

  Segovia Hospital

  PRINCIPAL INVESTIGATOR

• María José Peñarrubia, MD

  Río Hortega Hospital

  PRINCIPAL INVESTIGATOR

• Alejandro Martín, MD

  Virgen de la Concha Hospital

  PRINCIPAL INVESTIGATOR

• Sílvia Fernández, MD

  León Hospital

  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: April 14, 2008
• First Posted: May 26, 2011
• Study Start: June 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

ES (19)