NCT01361191

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-05-26
• Last updated: 2013-10-30

Locations

19 sites across 1 country: Spain