High Dose CHOP in Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192764
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2010
Information provided by:
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: high-dose cyclophosphamide Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Short High-dose CHOP Chemotherapy for Aggressive Non-Hodgkin's Lymphoma
Study Start Date : December 1996
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Failure-free survival

Secondary Outcome Measures :
  1. overall survival
  2. response rate
  3. toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192764

Department of Oncology, Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Ron Epelbaum, MD nonaffiliated Identifier: NCT00192764     History of Changes
Other Study ID Numbers: RonHDCHOP.CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010

Keywords provided by Rambam Health Care Campus:
large cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists