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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01361191
First received: April 14, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Follicular Grade 3B Lymphoma
Drug: R-MEGACHOP
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Treatment Stratification Based on PET Scan Response to R-MEGACHOP Followed by R-MEGACHOP or R-IFE Plus Peripheral Autologous Stem Cell Transplant (PBSCT) in Patients With Poor Prognosis DLBCL

Resource links provided by NLM:


Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:

Primary Outcome Measures:
  • 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 [ Time Frame: 5 years follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the overall survival after three years. Further secondary outcomes as described in study summary. [ Time Frame: 5 years follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: June 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: R-MEGACHOP
    • 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).

Detailed Description:

In addition to the above:

  • To evaluate the overall survival after three years.
  • To determine the rate of global responses and complete remissions, uncertain and partial.
  • To determine the duration of the complete response after the treatment termination.
  • To carry out an exploratory follow up of the event free survival and the overall survival at 5 years.
  • To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI).
  • To asses the role of PET in the disease stage and response evaluation compared to CAT.
  • To identify the predictable response factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis.
  • To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
  2. 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.
  3. 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
  4. Life expectancy over 12 weeks
  5. Written informed consent form 6. New diagnosed patient without any previous treatment

Exclusion Criteria:

  1. Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
  2. uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg)
  3. 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.
  4. other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
  5. patients positive for HIV
  6. patients with transformed follicular lymphoma
  7. pregnant women or in nursing; women of childbearing age who do not use an adequate contraceptive method before being included in the study
  8. ventricular ejection fraction inferior to 50%
  9. patients with severe psychiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361191

Locations
Spain
ICO- Hospital Duran i Reynals
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain, 11407
Hospital Clínico Univ. de Santiago
Santiago de Compostela, Galicia, Spain, 15706
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain, 07198
Hospital Univ. Son Dureta
Palma de Mallorca, Mallorca, Spain, 07014
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Complejo Hospitalario de Jaén
Jaén, Spain, 23006
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Univ. Morales Meseguer
Murcia, Spain, 30008
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital General de Segovia
Segovia, Spain, 40002
Hospital Universitario Río Hortega
Valladolid, Spain, 47010
Hospital Universitario Virgen de la Concha
Zamora, Spain, 49022
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01361191     History of Changes
Other Study ID Numbers: GEL/TAMO-2006, EudraCT number 2006-005254-68
Study First Received: April 14, 2008
Last Updated: October 29, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
DLBCL
PET
IPI
R-MegaCHOP
Autologous stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 17, 2014