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

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (Other)

Overall Status

Completed

CT.gov ID

NCT01361191

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Outcome Measures

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 [5 years follow-up]

Secondary Outcome Measures

To evaluate the overall survival after three years. Further secondary outcomes as described in study summary. [5 years follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICO- Hospital Duran i Reynals	Hospitalet de Llobregat	Barcelona	Spain	08907
2	Hospital de Jerez	Jerez de la Frontera	Cádiz	Spain	11407
3	Hospital Clínico Univ. de Santiago	Santiago de Compostela	Galicia	Spain	15706
4	Hospital Univ. Son Dureta	Palma de Mallorca	Mallorca	Spain	07014
5	Hospital Son Llàtzer	Palma de Mallorca	Mallorca	Spain	07198
6	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife	Spain	38320
7	Complejo Hospitalario de Jaén	Jaén		Spain	23006
8	Hospital Universitario La Princesa	Madrid		Spain	28006
9	Hospital Universitario Gregorio Marañon	Madrid		Spain	28007
10	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
11	Hospital Universitario La Paz	Madrid		Spain	28046
12	Hospital Univ. Morales Meseguer	Murcia		Spain	30008
13	Clínica Universitaria de Navarra	Pamplona		Spain	31008
14	Hospital Universitario de Salamanca	Salamanca		Spain	37007
15	Hospital Universitario Marques de Valdecilla	Santander		Spain	39008
16	Hospital General de Segovia	Segovia		Spain	40002
17	Hospital Universitario Río Hortega	Valladolid		Spain	47010
18	Hospital Universitario Virgen de la Concha	Zamora		Spain	49022
19	Hospital Clínico Lozano Blesa	Zaragoza		Spain	50009