Skip to content

The efficacy of Lenalidomide - Rituximab (LR) vs Bendamustine â??Rituximab (BR) in untreated follicular lymphoma

A phase III Open label Randomized study to compare the efficacy of Lenalidomide - Rituximab (LR) vs Bendamustine â??Rituximab (BR) in treatment naïve follicular lymphoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006904
Enrollment
74
Registered
2016-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Treatment naive follicular lymphoma

Interventions

Intervention1: Lenalidomide and Rituximab: Tab Lenalidomide 20mg d1-d21,Inj Rituximab 375 mg/m2 on d1 q 28 day . Total 6 cycles Control Intervention1: bendamustine and rituximab: Inj Bendamustine 90 m

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >=18 years at diagnosis 2. low grade lymphoma-FL 3. ECOG PS â?? 0-2 4. Stage-II â?? IV ( if symptomatic) 5. Normal organ function - creatinine clearance >60ml/min; SGOT and SG PT < 2.5times of ULN

Exclusion criteria

Exclusion criteria: 1. CD 20 negative NHL 2. Grade 3b Follicular Lymphoma 3. H/o previous malignancy within the past 5 years, uncontrolled serious systemic illness, HIV infection, or active hepatitis B or C infection 4. Not willing for enrollment

Design outcomes

Primary

MeasureTime frame
The primary endpoints -Complete response rate will be assessed according to IWG criteria 7. Secondary endpoints: - Overall response rate - Safety and toxicityTimepoint: Jan 2016- Jan 2018

Secondary

MeasureTime frame
Secondary endpoints: - Overall response rateTimepoint: Jan 2016- Jan 2018;Secondary endpoints: - Safety and toxicityTimepoint: Jan 2016- Jan 2018

Countries

India

Contacts

Public ContactSusanta Kumar Paikaray

AIIMS

ajaygogia@gmail.com9013000642

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026