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Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide and Rituximab (LR)-ESHAP in Patients With Diffuse Large B-cell Lymphoma

NCT02340936 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-01-10

No results posted yet for this study

Summary

The purpose of the Phase I of the study is to evaluate the safety and the maximum-tolerated dose (MTD) of the combination R-ESHAP with lenalidomide as salvage therapy for patients with relapsed or refractory diffuse large B-cell lymphoma The purpose of the Phase II of the study is to evaluate ORR of LR-ESHAP in patients with relapsed or refractory DLBCL candidates to HDT and ASCT

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

LR-ESHAP (lenalidomide 5 mg)

3 cycles of lenalidomide 5mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.

DRUG

LR-ESHAP (lenalidomide 10 mg)

3 cycles of lenalidomide 10mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.

DRUG

LR-ESHAP (lenalidomide 15 mg)

3 cycles of lenalidomide 15mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.

DRUG

LR-ESHAP (lenalidomide 20 mg)

3 cycles of lenalidomide 20mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Dynamic Science S.L.

    collaborator INDUSTRY

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Alejandro Martin · University of Salamanca

  • Dolores Caballero · University of Salamanca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-09-30
Completion
2019-02-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340936 on ClinicalTrials.gov