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sequential R-CHOP

Phase 2

PTLD | Small molecule | Other |Pulmonx Corporation|Last Updated: Mar 7, 2017

Success Probability

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

sequential R-CHOP · 1 trial · 2 indications

Phase 2 1
NCT00590447Risk Stratified Sequential Treatment for CD20-positive PTLDPTLD
COMPLETED152 Analytics
PHASE2COMPLETED
Risk Stratified Sequential Treatment for CD20-positive PTLD
PTLDUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is the evaluation of the efficacy.For this aim the overall objective response rates after therapy = complete and partial response and the duration of the response will be measured.
evaluated 4 weeks after comleting therapy

Secondary Endpoints

The secondary objective is to determine the adverse events and tolerability of rituximab and/or chemotherapy. Furthermore, the long-term safety will be determined, especially the frequency of complicating infections and the overall survival.
within 2 years of follow up
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALAll patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Patients achieving a CR after the first 4 applications of single agent rituximab (evaluated between day 40 to 50) will go on with 4 further courses of single agent rituximab on days 50, 72, 94 and 116.
BEXPERIMENTALAll patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Patients who do not achieve a CR after the first 4 applications of single agent rituximab (evaluated between day 40 to 50) will go on with 4 courses of R-CHOP on days 50, 72, 94 and 116.

Interventions

NameTypeDescription
rituximab monotherapyDRUG375 mg/m2, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between course 4 and 5 the patients directly enter R-CHOP chemotherapy (Arm B).
sequential R-CHOPDRUG375 mg/m2 rituximab, IV on days 1, 8, 15, 22, 50, 72, 94 and 116. Cyclophosphamid 750 mg/m2, adriamycine 50 mg/m2 and vincristine 1.4mg/m2, IV and prednisone 50mg/m2, PO every 3 weeks at days 50, 72, 94 and 116. In case of disease progression during the first 4 administration of rituximab antibody or the 4 weeks interval between antibody and R-CHOP administration the patients directly enter R-CHOP chemotherapy.
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * PTLD with or without EBV association, confirmed after biopsy or resection of tumor * Measurable disease of \> 2 cm in diameter and/or bone marrow involvement * Patients having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or other or a combina...

Countries:AustraliaBelgiumFranceGermanyItalyPolandSweden
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Frequently asked questions about sequential R-CHOP

What is sequential R-CHOP used for?

Sequential R-CHOP is used for post-transplant lymphoproliferative disorder (PTLD), a condition that can occur after organ transplantation. It is a treatment regimen being studied in patients with CD20-positive PTLD.

Who is developing sequential R-CHOP?

Sequential R-CHOP is being developed by Pulmonx Corporation, which trades under the ticker LUNG on the stock market. The company is conducting clinical research on this treatment for PTLD.

What phase is sequential R-CHOP in?

Sequential R-CHOP is in Phase 2 clinical development. It is an investigational treatment for PTLD and has not yet been approved by regulatory authorities. The Phase 2 trial has been completed.

What clinical trials is sequential R-CHOP in?

Sequential R-CHOP is being studied in a completed Phase 2 trial with the identifier NCT00590447, titled 'Risk Stratified Sequential Treatment for CD20-positive PTLD.' The trial enrolled 152 participants across multiple countries including Australia, Belgium, France, Germany, Italy, Poland, and Sweden.

Is sequential R-CHOP the same as R-CHOP?

Sequential R-CHOP is a specific regimen that involves giving R-CHOP in a sequential manner, as opposed to standard R-CHOP. It is being studied for PTLD, and the trial focuses on risk-stratified treatment for CD20-positive PTLD.