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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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02340936Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide and Rituximab (LR)-ESHAP in Patients With Diffuse Large B-cell LymphomaPHASE1 COMPLETED 53 — — Jan 1, 2011Feb 20, 2019Jan 10, 20209 Spain
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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 — 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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