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R-CHOEP14x6+HD-AraC+HD-Mtx

Phase 2

Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Sep 30, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

R-CHOEP14x6+HD-AraC+HD-Mtx · 1 trial · 1 indication

Phase 2 1
NCT01502982Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)Diffuse Large B-Cell Lymphoma
COMPLETED160 Analytics
PHASE2COMPLETED
Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)
Diffuse Large B-Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to treatment failure
5 years

Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day.

Secondary Endpoints

Number of participants with adverse events
Treatment period (5 years)
Clinical response rate
Treatment period (5 years)
Time to progression
5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ChemoimmunotherapyEXPERIMENTAL -

Interventions

NameTypeDescription
R-CHOEP14x6+HD-AraC+HD-MtxDRUGrituximab 375 mg/m2 day 1 cyclophosphamide 750 mg/m2 day 1 doxorubicin 50 mg/m2 day 1 vincristine 1.4 mg/m2 day 1 etoposide 100mg/m2 days 1,2,3 Prednison 100 mg days 1,2,3,4,5 cycle repeated six times every two weeks followed by HD-AraC 3g/m2x4 and HD-mtx 3 g/m2 HD-AraC 3g/m2x4 times every 12 h
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Age ≥ 18 - \< 65 years. 2. Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry: * Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and ca...

Countries:DenmarkFinlandNorwaySweden
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Frequently asked questions about R-CHOEP14x6+HD-AraC+HD-Mtx

What is R-CHOEP14x6+HD-AraC+HD-Mtx used for?

R-CHOEP14x6+HD-AraC+HD-Mtx is an investigational combination chemotherapy regimen being studied for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). It is currently in Phase 2 clinical development and is not approved by regulatory authorities.

Who is developing R-CHOEP14x6+HD-AraC+HD-Mtx?

R-CHOEP14x6+HD-AraC+HD-Mtx is being developed by Amgen Inc. (NASDAQ: AMGN). The company is conducting clinical trials to evaluate this regimen in patients with Diffuse Large B-Cell Lymphoma.

What phase is R-CHOEP14x6+HD-AraC+HD-Mtx in?

R-CHOEP14x6+HD-AraC+HD-Mtx is in Phase 2 clinical development. It is an investigational regimen, meaning it has not been approved by the FDA or other regulatory agencies and is still being studied for safety and efficacy.

What clinical trials is R-CHOEP14x6+HD-AraC+HD-Mtx in?

R-CHOEP14x6+HD-AraC+HD-Mtx is associated with one completed Phase 2 clinical trial, NCT01502982, titled 'Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)'. The trial enrolled 160 participants across Denmark, Finland, Norway, and Sweden.

Is R-CHOEP14x6+HD-AraC+HD-Mtx FDA approved?

No, R-CHOEP14x6+HD-AraC+HD-Mtx is not FDA approved. It is an investigational combination regimen currently in Phase 2 clinical trials for Diffuse Large B-Cell Lymphoma. Approval status has not been granted, and it remains under clinical investigation.