High Dose CHOP in Lymphoma | NCT00192764

Studies
High Dose CHOP in Lymphoma

NCT00192764

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Sep 22, 2010Estimated

Enrollment

Phase

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Interventions

high-dose cyclophosphamide

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1996

Primary Completion Date

Not provided

Completion Date

Sep 2010Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2010

Last Update Posted Date

Sep 22, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
high-dose cyclophosphamide	Drug

Measure	Description	Time Frame
Failure-free survival

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Epelbaum, MD	nonaffiliated	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Rambam Medical Center		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D054739	Dendritic Cell Sarcoma, Interdigitating

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided