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LR-ESHAP

Phase 1

Diffuse Large B-cell Lymphoma | Small molecule | Oncology |Thermo Fisher Scientific Inc|Last Updated: Jan 10, 2020

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

LR-ESHAP · 1 trial · 1 indication

Phase 1 1
NCT02340936Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide and Rituximab (LR)-ESHAP in Patients With Diffuse Large B-cell LymphomaDiffuse Large B-cell Lymphoma
COMPLETED53 Analytics
PHASE1COMPLETED
Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide and Rituximab (LR)-ESHAP in Patients With Diffuse Large B-cell Lymphoma
Diffuse Large B-cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase I of the study: 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 (determine maximum tolerated dose)
During 3 cycles of treatment (2 months after the initiation of study treatment)

To determine the MTD of the combination R-ESHAP with lenalidomide

Phase II of the study: Phase II: to evaluate ORR of LR-ESHAP in patients with relapsed or refractory DLBCL candidates to HDT and ASCT (determine the overall response rate)
After 3 cycles of treatment (2 months after the initiation of study treatment)

To determine the overall response rate of LR-ESHAP

Secondary Endpoints

Phase I of the study: to analyze the adverse events of LR-ESHAP (frequency and severity of the adverse events)
During study treatment period (3 cycles of LR-ESHAP and ASCT) until end of treatment visit (3 months after ASCT)
Phase I of the study: preliminarily analyze effectiveness (response rates (CR and PR), duration of response and survival (DFS and OS)
After 3 cycles of treatment (two months after the initiation of the study treatment) and during follow-up period (36 months)
Phase I of the study: evaluate haematopoietic progenitor cells mobilization after treatment with LR-ESHAP (Evaluate CD34+ cell count)
After cycle 2 (5 weeks after the initiation of study treatment) or cycle 3 (9 weeks after the initiation of study treatment)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LR-ESHAP (lenalidomide 5 mg)EXPERIMENTALIntervention: lenalidome 5mg combined with R-ESHAP (3 cycles of treatment every 21 days: lenalidomide 5 mg/day (day 1 to 14 except cycle 2 that will be administered from day 1 to 10), etoposide 40 mg/m2/day (day 1 to day 4), methylprednisolone 500 mg/day (day 1 to day 5), cisplatin 25 mg/m2/day (day 1 to day 4), cytarabine 2000 mg/m2 (day 5) and rituximab 375 mg/m2 (day 1 or 5)).
LR-ESHAP (lenalidomide 10mg)EXPERIMENTALIntervention: lenalidome 10mg combined with R-ESHAP( 3 cycles of treatment every 21 days: lenalidomide 10 mg/day (day 1 to 14 except cycle 2 that will be administered from day 1 to 10), etoposide 40 mg/m2/day (day 1 to day 4), methylprednisolone 500 mg/day (day 1 to day 5), cisplatin 25 mg/m2/day (day 1 to day 4), cytarabine 2000 mg/m2 (day 5) and rituximab 375 mg/m2 (day 1 or 5)).
LR-ESHAP (lenalidomide 15mg)EXPERIMENTALIntervention: lenalidome 15mg combined with R-ESHAP (3 cycles of treatment every 21 days: lenalidomide 15 mg/day (day 1 to 14 except cycle 2 that will be administered from day 1 to 10), etoposide 40 mg/m2/day (day 1 to day 4), methylprednisolone 500 mg/day (day 1 to day 5), cisplatin 25 mg/m2/day (day 1 to day 4), cytarabine 2000 mg/m2 (day 5) and rituximab 375 mg/m2 (day 1 or 5)).
LR-ESHAP (lenalidomide 20mg)EXPERIMENTALIntervention: lenalidome 20mg combined with R-ESHAP (3 cycles of treatment every 21 days: lenalidomide 20 mg/day (day 1 to 14 except cycle 2 that will be administered from day 1 to 10), etoposide 40 mg/m2/day (day 1 to day 4), methylprednisolone 500 mg/day (day 1 to day 5), cisplatin 25 mg/m2/day (day 1 to day 4), cytarabine 2000 mg/m2 (day 5) and rituximab 375 mg/m2 (day 1 or 5)).

Interventions

NameTypeDescription
LR-ESHAP (lenalidomide 5 mg)DRUG3 cycles of lenalidomide 5mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
LR-ESHAP (lenalidomide 10 mg)DRUG3 cycles of lenalidomide 10mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
LR-ESHAP (lenalidomide 15 mg)DRUG3 cycles of lenalidomide 15mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
LR-ESHAP (lenalidomide 20 mg)DRUG3 cycles of lenalidomide 20mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. The patient must, at the investigator's opinion, be able to meet all requirements of the clinical trial. 2. Patients must give voluntarily informed consent before performing any test test that is not part of routine care of patients. 3. Age between 18 and 70 years. 4. Candida...

Countries:Spain
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Frequently asked questions about LR-ESHAP

What is LR-ESHAP used for?

LR-ESHAP is an investigational small molecule being studied for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). It is a combination regimen that includes lenalidomide and rituximab, along with the ESHAP chemotherapy components. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes LR-ESHAP?

LR-ESHAP is being developed by Thermo Fisher Scientific Inc, a company publicly traded under the ticker symbol TMO. The company is conducting clinical research to evaluate the safety and efficacy of this drug combination in patients with Diffuse Large B-cell Lymphoma.

What phase is LR-ESHAP in?

LR-ESHAP is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 clinical trial has been completed to determine the dose, safety, and efficacy of the lenalidomide and rituximab (LR)-ESHAP combination in patients with Diffuse Large B-cell Lymphoma.

What clinical trials is LR-ESHAP in?

LR-ESHAP has one completed clinical trial registered under NCT02340936. This Phase 1 study, titled "Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide and Rituximab (LR)-ESHAP in Patients With Diffuse Large B-cell Lymphoma," enrolled 53 participants in Spain. The trial included adults aged 18 years and older.

Is LR-ESHAP the same as lenalidomide and rituximab?

LR-ESHAP is a combination regimen that includes lenalidomide and rituximab, but it is not the same as those drugs alone. The name LR-ESHAP refers to the full combination of lenalidomide (L), rituximab (R), and the ESHAP chemotherapy regimen. It is being studied specifically for Diffuse Large B-cell Lymphoma.