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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Genzyme, a Sanofi Company; Sunnybrook Health Sciences Centre
• Treatments: Alemtuzumab

Criteria

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:

Nodal:

• Peripheral T-cell lymphoma not otherwise specified (PTL NOS)

• Angioimmunoblastic lymphadenopathy (AILD)

• ALK 1 negative anaplastic large cell NHL

Extranodal:

• 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