High Dose CHOP in Lymphoma
September 21, 2010 updated by: Rambam Health Care Campus
Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma
The study hypothesis is that intensification of CHOP by dose escalation of the most active drugs in the combination will improve treatment outcome.
Patients with diffuse large-cell lymphoma are treated by high cyclophosphamide containing CHOP.
The planned dose is 3000 mg/m2 which is 4 times the atandard one.
Only 4 cycles are given.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel
- Department of Oncology, Rambam Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- large-cell non-Hodgkin's lymphoma
- IPI low-intermediate, high-intermediate and high or bulky mediastinum
- age 18-65
Exclusion Criteria:
- previous treatment for lymphoma
- serious concurrent systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Failure-free survival
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Secondary Outcome Measures
Outcome Measure |
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overall survival
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response rate
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toxicity
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron Epelbaum, MD, nonaffiliated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1996
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
September 22, 2010
Last Update Submitted That Met QC Criteria
September 21, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- RonHDCHOP.CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.