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
|
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
Study start: July 2004
Eligibility
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:
Location and Contact Information
New York
Weill Medical College of Cornell University, New York, New York, 10021, United States; Recruiting
Richard Furman, MD, Principal Investigator
Richard Furman, MD, Principal Investigator, Weill Medical College of Cornell University
More Information
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
- Langerhans Cell Histiocytosis (Cleveland Clinic)
- Langerhans Cell Histiocytosis (child (Cleveland Clinic)

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