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

Primary Purpose

Diffuse Large B-cell Lymphoma, Follicular Grade 3B Lymphoma

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

R-MEGACHOP

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, PET, IPI, R-MegaCHOP, Autologous stem cell transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Outcomes

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

Secondary Outcome Measures

To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.

Full Information

NCT ID

NCT01361191

First Posted

April 14, 2008

Last Updated

October 29, 2013

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

1. Study Identification

Unique Protocol Identification Number

NCT01361191

Brief Title

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

Acronym

R-MEGACHOP

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 Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma, Follicular Grade 3B Lymphoma

Keywords

DLBCL, PET, IPI, R-MegaCHOP, Autologous stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

R-MEGACHOP

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time Frame

5 years follow-up

Secondary Outcome Measure Information:

Title

To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.

Time Frame

5 years follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: