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

October 29, 2013 updated by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaén, Spain, 23006
        • Complejo Hospitalario de Jaén
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Murcia, Spain, 30008
        • Hospital Univ. Morales Meseguer
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Valladolid, Spain, 47010
        • Hospital Universitario Rio Hortega
      • Zamora, Spain, 49022
        • Hospital Universitario Virgen de la Concha
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • ICO- Hospital Duran i Reynals
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital de Jerez
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Hospital Clínico Univ. de Santiago
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07014
        • Hospital Univ. Son Dureta
      • Palma de Mallorca, Mallorca, Spain, 07198
        • Hospital Son Llatzer
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.
Time Frame: 5 years follow-up
5 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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: Eva González, MD, Duran i Reynals 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEL/TAMO-2006
  • EudraCT number 2006-005254-68

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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