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Peripheral T-cell LymphomasPhase 1/2ACCAPELANCT00453427

Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas

A Phase 1/2 study testing Alemtuzumab (Campath-1H) in people with Peripheral T-cell Lymphomas, run by Ontario Clinical Oncology Group (OCOG) at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objectives of this study are to: 1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and 2. to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-cell Lymphomas
What is being tested?
Alemtuzumab (Campath-1H)
How many people
20 participants
Where
5 sitesCanada
Study dates
Sep 2006to May 2015
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

Who may be able to join

  • Patients aged 18 years of age or older at time of enrollment,
  • Histologically proven and centrally reviewed CD52+ T-cell NHL Stages 2-4 including the following nodal and extranodal subtypes:
  • Nodal:
  • Peripheral T-cell lymphoma not otherwise specified (PTL NOS)
  • Angioimmunoblastic lymphadenopathy (AILD)
  • ALK 1 negative anaplastic large cell NHL
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  • Extranodal:
  • Hepatosplenic
  • Enteropathy-associated
  • Panniculitic

Who cannot join

  • Previous treatment with chemotherapy or radiation with the exception of up to 1 cycle of CHOP chemotherapy.
  • Expected survival < 4 months.
  • ECOG performance status > 3.
  • Inadequate haematologic function (Hb < 85g/L, ANC < 1000/mm3, or platelet count < 75,000/mm3) unless directly attributable to the NHL.
  • Inadequate hepatic function (total bilirubin > 35μmol/L, alkaline phosphatase > 2x UL normal, AST/ALT > 2x UL normal)
  • Inadequate renal function (serum creatinine > 130μmol/L), unless directly attributable to the NHL.
Show all 16Show fewer
  • Non-measurable or non-evaluable disease, according to criteria of Cheson et al49.
  • Geographically inaccessible for follow-up
  • Known hypersensitivity to study drugs
  • Serious illnesses that may interfere with subject compliance, determination of causality of adverse events or would compromise other protocol objectives.
  • Known HIV positivity or other pre-existing immunodeficiency (e.g., post-organ transplant).
  • Known CNS involvement with lymphoma (tests to investigate CNS involvement are required only if clinically indicated).
  • Pregnant or lactating women.
  • Women who are of childbearing potential but are not using effective contraception. Men with reproductive potential who are not using effective contraception.
  • Previous malignancy within the last 5 years with the exception of cervical carcinoma in situ or non melanoma skin cancer.
  • Nasal natural killer (NK) T-cell NHL

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Sunnybrook Health Sciences Centre, Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

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

The primary objectives of this study are to:

  1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and
  2. to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules.

This will then determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation.

The secondary objectives are to:

  1. establish the efficacy of combination alemtuzumab with CHOP chemotherapy; and
  2. to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell reconstitution and cytomegalovirus (CMV) reactivation.
Read the detailed description

Aggressive peripheral T-cell lymphomas account for 10 - 15% of all Non-Hodgkin's Lymphoma (NHL) and present with more adverse prognostic features than aggressive histology B-cell NHL . Correspondingly, they have an overall poorer prognosis than B-cell lymphomas, achieving lower complete response rates, freedom from progression and overall survival with conventional anthracycline-based CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Fewer than 30% of patients are cured with therapy. New treatments that replicate the improved survivals with chemo-immunotherapy for B-cell lymphomas are needed. Alemtuzumab is a humanized murine antibody that binds to a ubiquitous lymphoid marker CD52 and is efficacious (as monotherapy) in related lymphoproliferative diseases. Combining alemtuzumab with CHOP chemotherapy may improve the response rates and outcomes of patients with this sub-type of NHL. The combination must be first tested in a dose escalation fashion to establish the dosage of the doublet because of the potential for overlapping or exaggerated toxicities.

This prospective, multi-center, open label Phase I-II study will enroll 22-84 patients with newly diagnosed previously untreated aggressive histology peripheral T-cell lymphomas. In the Phase I component, patients will be sequentially enrolled in cohorts of three patients and treated with increasing doses of alemtuzumab administered in combination with standard CHOP chemotherapy. When the maximal tolerated dose is determined, this dose and schedule will then be tested in up to 46 patients using a Simon two stage Phase II design.

Being tested
Alemtuzumab (Campath-1H)
Keywords
PTL NOS, AILD, NHL, CHOP
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

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

  • Alemtuzumab (Campath-1H)Drug

    The investigational drug is alemtuzumab (Campath-1H). It is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (> 95%) normal lymphocytes and T-cell and B-cell lymphomas. Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and anti-tumour T-cell activity.

What is being measured

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

  1. toxicity

    Measured: 8 cycles of treatment

Secondary outcomes (4)

  1. efficacy

    Measured: Post cycle 3 and Post cycle 8

  2. tumour response

    Measured: Post Cycle 3 and Post Cycle 8 Q 6 months in Followup

  3. pharmacokinetic analysis

    Measured: Day 1 of 8 Cycles of treatment and Post Last Dose on Day 3,6,10,13

  4. immunological monitoring

    Measured: Baseline Day 1 On Treatment Day 1 Cycle 4 and Cycle 8 and 6 months Follow-up

Timeline

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

  1. First posted29 Mar 2007 (estimated)
  2. Study startSep 2006
  3. Primary completionJun 2013
  4. Study completionMay 2015

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00453427
Sponsor's protocol ID
CTA-Control-103662
Acronym
ACCAPELA
Status last verified
Jun 2015
First submitted
27 Mar 2007
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alemtuzumab (Campath-1H) in people with Peripheral T-cell Lymphomas, run by Ontario Clinical Oncology Group (OCOG) 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?

The sponsor lists 10 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Jun 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicity (time frame: 8 cycles of treatment). 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 NCT00453427.

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 3 Jun 2015.

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