Recruiting
Phase 1
Phase 2

Alemtuzumab & Chemotherapy

Sponsor:

Toronto Sunnybrook Regional Cancer Centre

Code:

NCT00363090

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

alemtuzumab

cyclophosphamide

doxorubicin hydrochloride

prednisone

vincristine sulfate

Study Details

Brief summary:

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, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, 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/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Conditions

Lymphoma

Study ID

NCT00363090

Start date

Sep, 2006

Status verified date

Jun, 2009

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive peripheral T-cell non-Hodgkin's lymphoma (NHL), including the following nodal or extranodal subtypes:

  • Nodal:

  • Angioimmunoblastic lymphadenopathy
  • ALK 1-negative anaplastic large cell NHL
  • Peripheral T-cell lymphoma not otherwise specified
  • Extranodal:

  • Hepatosplenic NHL
  • Enteropathy-associated NHL
  • Panniculitic NHL
  • Stage II-IV disease
  • Newly diagnosed, CD52+ disease
  • Measurable or evaluable disease
  • No known CNS involvement with lymphoma
  • No nasal natural killer T-cell NHL

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 4 months
  • Absolute neutrophil count ≥ 1,000/mm³\*
  • Platelet count ≥ 75,000/mm³\*
  • Hemoglobin ≥ 8.5 g/dL\*
  • Bilirubin < 2.0 mg/dL
  • Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
  • AST or ALT < 2 times ULN
  • Creatinine < 1.5 mg/dL\*
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known hypersensitivity to any of the study drugs
  • No serious illnesses that would preclude compliance with study requirements
  • No known HIV positivity
  • No other preexisting immunodeficiency (e.g., post-organ transplant)
  • No other malignancy within the past 5 years except cervical carcinoma in situ or nonmelanoma skin cancer NOTE: \*Unless directly attributable to NHL

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy

  • Up to 7 days of prednisone preceding initiation of chemotherapy allowed
  • No other concurrent chemotherapy, radiotherapy, or immunotherapy
  • No other concurrent corticosteroids except dexamethasone used as an antiemetic for a brief period

Study Design

Enrollment

84 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

alemtuzumab

cyclophosphamide

doxorubicin hydrochloride

prednisone

vincristine sulfate

flow cytometry

pharmacological study

Primary outcome measure

  • Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0 [ Time Frame: undefined ]
  • Safety [ Time Frame: undefined ]
  • Dose-limiting toxicities [ Time Frame: undefined ]
  • Pharmacokinetics of alemtuzumab [ Time Frame: undefined ]

Central Contacts and Locations

Locations

St. Paul's Hospital at Providence Health Care - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Contact Person

604-806-9656

Margaret and Charles Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, N6A 4L6

Contacts

Graeme Fraser, MD, FRCPC

905-575-7820

London Regional Cancer Program at London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 4L6

Contacts

Joy Mangel, MD

519-685-8615joy.mangel@lhsc.on.ca

Odette Cancer Centre at Sunnybrook

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rena Buckstein, MD

416-480-5847rena.buckstein@sunnybrook.ca

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Michael R. Crump, MD, FRCPC

416-946-4567michael.crump@uhn.on.ca

More Information

Sponsor

Toronto Sunnybrook Regional Cancer Centre

Last update posted

Sep 20, 2013

Last verified

Jun, 2009

Keywords

  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Toronto Sunnybrook Regional Cancer Centre on 2013-09-20.