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Phase I Study of CHOP + Campath for T-Cell, Null Cell, or NK Cell Lymphoma - Article


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Langerhans Cell Histiocytosis

LCH 




Clinical Trial: Phase I Study of CHOP + Campath for T-Cell, Null Cell, or NK Cell Lymphoma

This study is currently recruiting patients.
Verified by Weill Medical College of Cornell University August 2005

Sponsors and Collaborators: Weill Medical College of Cornell University
Berlex, Inc.
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00161590

Purpose

Primary Objective:

- To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with CHOP chemotherapy (C-CHOP) in patients with T-cell, Null-cell and NK-cell lymphomas.

Secondary Objectives:

  • To evaluate response rate, overall survival and disease-free survival in patients with T-cell, Null-cell and NK-cell lymphomas treated with Campath + CHOP chemotherapy.
  • To assess the incidence of CMV reactivation in patients with these lymphomas treated with the Campath + CHOP combination.
  • To determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of GPI-linked proteins.
Condition Intervention Phase
T-Cell Lymphoma
NK cell lymphoma
Null cell lymphoma
 Drug: CHOP, alemtuzumab
Phase I

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment

Official Title: Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK Cell Lymphomas

Further Study Details: 

Study start: July 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients must have a diagnosis of non-B-cell, non-Hodgkin’s lymphoma (including T-cell, Null-cell, or NK-cell lymphoma, but excluding lymphoblastic lymphoma)
  • Stage II, III, or IV disease requiring chemotherapy
  • At least one site of measurable disease, 1.5 cm in diameter or greater
  • Age > or = 18 years
  • Absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor
  • Platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor
  • Creatinine less than 2 x ULN
  • Total bilirubin less than 2 x ULN (dose reduce vincristine and adriamycin required for bilirubin > 1.2 mg/dL)
  • Echo or MUGA documenting a normal ejection fraction prior to chemotherapy
  • Able to give informed consent

Exclusion Criteria:

  • Known CNS involvement
  • Known HIV disease
  • Patients who are pregnant or nursing
  • Any factor which might limit the patient’s ability to provide informed consent
  • Life expectancy < 3 months
  • Patients who are unwilling to agree to use an effective means of birth control while on treatment

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00161590

Richard Furman, MD      212-746-2932 

New York
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States; Recruiting
Richard Furman, MD  212-746-2932 
Richard Furman, MD,  Principal Investigator

Study chairs or principal investigators

Richard Furman, MD,  Principal Investigator,  Weill Medical College of Cornell University   

More Information

Study ID Numbers:  0204-157
Last Updated:  September 11, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00161590
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

Resources



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Page Updated: October 3, 2005
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