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CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas
This study is currently recruiting participants.
Study NCT00323323   Information provided by Ohio State University Comprehensive Cancer Center
First Received: May 8, 2006   Last Updated: December 27, 2007   History of Changes

May 8, 2006
December 27, 2007
March 2004
December 2008   (final data collection date for primary outcome measure)
  • Maximum tolerated dose [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose
  • Adverse events
Complete list of historical versions of study NCT00323323 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Week 1 and Week 8 ] [ Designated as safety issue: No ]
Pharmacokinetics
 
CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas
A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.

Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Non-Hodgkin's Lymphoma
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
  • Drug: Alemtuzumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
34
 
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD-20 Negative
  • Previous treatment permitted: radiation, electron beam radiotherapy, PUVA, corticosteroids, IFN, low dose methotrexate, retinoids, Ontak
  • CNS disease permitted

Exclusion Criteria:

  • Pregnant or Nursing
  • prior Alemtuzumab
  • history of active Hep C
Both
18 Years and older
No
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com
United States
 
NCT00323323
Pierluigi Porcu, M.D., Ohio State University Comprehensive Cancer Center
OSU-0303
Ohio State University Comprehensive Cancer Center
 
Principal Investigator: Pierluigi Porcu Ohio State University
Ohio State University Comprehensive Cancer Center
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP