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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Río 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 Maranon 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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