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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453427
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : June 3, 2015
Sunnybrook Health Sciences Centre
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphomas Drug: Alemtuzumab (Campath-1H) Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas: A Multi-centre Phase I and II Study
Study Start Date : September 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Alemtuzumab
U.S. FDA Resources

Intervention Details:
    Drug: Alemtuzumab (Campath-1H)
    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.

Primary Outcome Measures :
  1. toxicity [ Time Frame: 8 cycles of treatment ]

Secondary Outcome Measures :
  1. efficacy [ Time Frame: Post cycle 3 and Post cycle 8 ]
  2. tumour response [ Time Frame: Post Cycle 3 and Post Cycle 8 Q 6 months in Followup ]
  3. pharmacokinetic analysis [ Time Frame: Day 1 of 8 Cycles of treatment and Post Last Dose on Day 3,6,10,13 ]
  4. immunological monitoring [ Time Frame: Baseline Day 1 On Treatment Day 1 Cycle 4 and Cycle 8 and 6 months Follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:


  • Peripheral T-cell lymphoma not otherwise specified (PTL NOS)
  • Angioimmunoblastic lymphadenopathy (AILD)
  • ALK 1 negative anaplastic large cell NHL


  • Hepatosplenic
  • Enteropathy-associated
  • Panniculitic

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453427

Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Sunnybrook Health Sciences Centre
Genzyme, a Sanofi Company
Principal Investigator: Rena Buckstein, MD Sunnybrook Health Sciences Centre, Odette Cancer Centre

Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00453427     History of Changes
Other Study ID Numbers: CTA-Control-103662
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Ontario Clinical Oncology Group (OCOG):

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents