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High Dose CHOP in Lymphoma

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
high-dose cyclophosphamide
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring large cell lymphoma, CHOP, cyclophosphamide, high-dose

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, Rambam Medical Center

Outcomes

Primary Outcome Measures

Failure-free survival

Secondary Outcome Measures

overall survival
response rate
toxicity

Full Information

First Posted
September 13, 2005
Last Updated
September 21, 2010
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00192764
Brief Title
High Dose CHOP in Lymphoma
Official Title
Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
large cell lymphoma, CHOP, cyclophosphamide, high-dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
high-dose cyclophosphamide
Primary Outcome Measure Information:
Title
Failure-free survival
Secondary Outcome Measure Information:
Title
overall survival
Title
response rate
Title
toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Epelbaum, MD
Organizational Affiliation
nonaffiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Rambam Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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High Dose CHOP in Lymphoma

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