Know Cancer

forgot password

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

Phase 2
18 Years
65 Years
Open (Enrolling)
Diffuse Large B-cell Lymphoma, Follicular Grade 3B Lymphoma

Thank you

Trial Information

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

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

- 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).

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years follow-up

Safety Issue:


Principal Investigator

José Fuster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Son Dureta Hospital


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

June 2007

Completion Date:

November 2011

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Follicular Grade 3B Lymphoma
  • PET
  • IPI
  • R-MegaCHOP
  • Autologous stem cell transplantation
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse