NCT00192764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 1996

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 22, 2010

Status Verified

September 1, 2010

First QC Date

September 13, 2005

Last Update Submit

September 21, 2010

Conditions

Non-Hodgkin's Lymphoma

Keywords

large cell lymphomaCHOPcyclophosphamidehigh-dose

Outcome Measures

Primary Outcomes (1)

  • Failure-free survival

Secondary Outcomes (3)

  • overall survival

  • response rate

  • toxicity

Interventions

high-dose cyclophosphamideDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • large-cell non-Hodgkin's lymphoma
  • IPI low-intermediate, high-intermediate and high or bulky mediastinum
  • age 18-65

You may not qualify if:

  • previous treatment for lymphoma
  • serious concurrent systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinDendritic Cell Sarcoma, Interdigitating

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Ron Epelbaum, MD

    nonaffiliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

December 1, 1996

Study Completion

September 1, 2010

Last Updated

September 22, 2010

Record last verified: 2010-09

Locations

IL(1)