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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Diffuse Large B-cell Lymphoma Follicular Grade 3B Lymphoma

Keywords

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DLBCL PET IPI R-MegaCHOP Autologous stem cell transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Spain

Other Identifiers

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EudraCT number 2006-005254-68

Identifier Type: -

Identifier Source: secondary_id

GEL/TAMO-2006

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

R-MEGACHOP

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Responsible Party

Principal Investigators

José Fuster, MD

Carlos Grande, MD

José Luís Bello, MD

Maria José Ramirez, MD

Carlos Panizo, MD

Elena Pérez, MD

Jorge Gayoso, MD

Reyes Arranz, MD

Eulogio Conde, MD

Eva González, MD

Miguel Canales, MD

Joan Bargay, MD

Miguel T. Hernández, MD

Antonio Alcala, MD

Luis Palomera, MD

José Queizán, MD

María José Peñarrubia, MD

Alejandro Martín, MD

Sílvia Fernández, MD

Locations

ICO- Hospital Duran i Reynals

Hospital Universitario Marques de Valdecilla

Hospital de Jerez

Hospital Clínico Univ. de Santiago

Complejo Hospitalario de Jaén

Hospital Universitario La Princesa

Hospital Universitario Gregorio Marañon

Hospital Universitario 12 de Octubre

Hospital Universitario La Paz

Hospital Univ. Son Dureta

Hospital Son Llàtzer

Hospital Univ. Morales Meseguer

Clínica Universitaria de Navarra

Hospital Universitario de Salamanca

Hospital Universitario de Canarias

Hospital General de Segovia

Hospital Universitario Río Hortega

Hospital Universitario Virgen de la Concha

Hospital Clínico Lozano Blesa

Countries

Other Identifiers

EudraCT number 2006-005254-68

GEL/TAMO-2006