Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00562068|
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 21, 2007
Last Update Posted : August 26, 2013
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Small Intestine Cancer||Biological: alemtuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
- To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.
- To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
- To monitor immune reconstitution after therapy.
- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
- To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.
OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.
After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||May 2009|
- Immediate toxicity (incidence of infusion-related reactions)
- Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
- Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
- Disease response (remission rate [complete response and partial response])
- Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
- Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
- Relative dose intensity
- Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
- Epstein-Barr virus copy number (measured retrospectively)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562068
|Leeds General Infirmary||Recruiting|
|Leeds, England, United Kingdom, LS1 3EX|
|Contact: Contact Person 44-113-392-3766|
|King's College Hospital||Recruiting|
|London, England, United Kingdom, SE5 9RS|
|Contact: Contact Person 44-20-3299-9000|
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-7352-8171|
|Manchester, England, United Kingdom, M20 4BX|
|Contact: Contact Person 44-161-446-8565|
|Torbay Devon, England, United Kingdom, TQ2 7AA|
|Contact: Contact Person 44-180-365-5260|
|Study Chair:||Roderick Johnson, MD||Leeds General Infirmary|