The Combination of Rad001 and Rituximab In Patients With Non-hodgkin's Lymphomas

Conditions

• Non-Hodgkin's Lymphomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Everolimus and rituximab — DRUG
  One injection of Rituximab 375 mg/m2 per week during 28 days followed by one Rituximab infusion every other cycle at 375 mg/m2 associated with everolimus at 5mg or 10 mg every day or 5 mg every other day.

Study Details

This study is an open label, multicenter study with two phases: * Phase I is a dose escalation study of RAD001 in combination with one injection of Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive non-Hodgkin's lymphomas to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). The purpose of the study is to assess the feasibility of the combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug interaction (DDI). * Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination at the RP2D in patients with lymphomas. Patients with lymphomas will be treated at the RP2D established during phase I and evaluated for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR) and stable disease (SD), and time to progression using the IWG criteria for treatment response. Induction therapy will follow the same schedule than during the phase I study. Maintenance therapy: Monthly cycles for up to 2 years with: * Daily RAD001 at the same dose than during induction therapy. * Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual maintenance schedule for Rituximab. Response to therapy will be assessed between day 42 and day 49, then every two months.

Key Dates

Start date

Dec 31, 2011

Status verified

Mar 2016

Primary completion

Jun 30, 2013

Completion

Dec 31, 2015

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Everolimus and rituximab

Primary Outcome Measure

Phase I part: Determination of the Recommended Dose of RAD001 in combination with rituximab. [ Time Frame: 28 days ]