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


Phase 1
18 Years
N/A
Not Enrolling
Both
T-Cell Lymphoma, Lymphoma, Non-Hodgkin's

Thank you

Trial Information

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


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 upper limits of normal (ULN)

- Total bilirubin less than 2 x ULN (dose reduced vincristine and adriamycin required
for bilirubin > 1.2 mg/dL)

- Echocardiogram (Echo) or multiple gate acquisition scan (MUGA) documenting a normal
ejection fraction prior to chemotherapy

- Able to give informed consent

Exclusion Criteria:

- Known central nervous system (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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Richard Furman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

0204-157

NCT ID:

NCT00161590

Start Date:

July 2004

Completion Date:

Related Keywords:

  • T-Cell Lymphoma
  • Lymphoma, Non-Hodgkin's
  • NK cell lymphoma
  • Null cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021