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NCT00192764 Clinical Trial

High Dose CHOP in Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00192764
Other study ID # RonHDCHOP.CTIL
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 21, 2010
Start date December 1996
Est. completion date September 2010

Study information
Verified date September 2010
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date September 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• high-dose cyclophosphamide

Locations
Country Name City State
Israel Department of Oncology, Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure-free survival
Secondary overall survival
Secondary response rate
Secondary toxicity
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