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LymphomaPhase 1/2NCT00363090

Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma

A Phase 1/2 study testing alemtuzumab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Toronto Sunnybrook Regional Cancer Centre at 5 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
alemtuzumab, cyclophosphamide and doxorubicin hydrochloride
How many people
84 participants
Where
5 sitesCanada
Study dates
Sep 2006to Dec 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites, 5 recruiting

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, N6A 4L6

    Graeme Fraser, MD, FRCPC, 905-575-7820

    Recruiting

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

    Joy Mangel, MD, 519-685-8615, joy.mangel@lhsc.on.ca

    Recruiting

  • Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

    Rena Buckstein, MD, 416-480-5847, rena.buckstein@sunnybrook.ca

    Recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Michael R. Crump, MD, FRCPC, 416-946-4567, michael.crump@uhn.on.ca

    Recruiting

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

    Vancouver, British Columbia, V6Z 1Y6

    Contact Person, 604-806-9656

    Recruiting

Other trials in Canada

About this study

Official title: Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study

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.

Read the detailed description

OBJECTIVES:

Primary

  • Establish the safety and dose-limiting toxicities of alemtuzumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) chemotherapy in patients with newly diagnosed, stage II-IV aggressive peripheral T-cell non-Hodgkin's lymphoma.
  • Measure the pharmacokinetics of alemtuzumab using different subcutaneous doses and schedules to determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation.

Secondary

  • Determine the efficacy of alemtuzumab in combination with CHOP chemotherapy using escalating doses and 2 different drug schedules, as defined by overall response rate, progression-free survival, and overall survival.
  • Measure the effects of this regimen on T-cell reconstitution and cytomegalovirus reactivation.

OUTLINE: This is a multicenter, phase I, dose-escalation study of alemtuzumab followed by an open-label, phase II study.

  • Phase I: 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) on day 1 OR on days 1, 8, and 15. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive CHOP chemotherapy and alemtuzumab (at the MTD determined in phase I) as in phase I (on the most effective regimen).

Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study treatment for pharmacokinetics and other correlative studies. Samples are examined for presence of cytomegalovirus antigen and by flow cytometry for B- and T-cell quantification.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.

Conditions
Lymphoma
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
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0

  2. Safety

  3. Dose-limiting toxicities

  4. Pharmacokinetics of alemtuzumab

Secondary outcomes (5)

  1. Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements

  2. Overall response rate

  3. Progression-free survival

  4. Overall survival

  5. Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363090
Sponsor's protocol ID
CDR0000491451
Other IDs
TSRCC-164-2006
Status last verified
Jun 2009
First submitted
10 Aug 2006
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing alemtuzumab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Toronto Sunnybrook Regional Cancer Centre at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00363090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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