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High Dose CHOP in Lymphoma

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ClinicalTrials.gov Identifier: NCT00192764
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2010
Sponsor:
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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00192764


Locations
Israel
Department of Oncology, Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ron Epelbaum, MD nonaffiliated

ClinicalTrials.gov 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
CHOP
cyclophosphamide
high-dose

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