CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

NCT00323323 | Completed Phase 1 DMC

• 1 other identifier: OSU-0303
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Conditions

Non-Hodgkin's Lymphoma

Keywords

Untreated; CD-20 Negative; Large B-Cell Lymphomas

Outcome Measures

Primary Outcomes (1)

• Toxicity and safety of concurrent CHOP and Alemtuzumab

  up to five years

Secondary Outcomes (3)

• Determine pharmacokinetics of Alemtuzumab

  up to five years

• Determine immunosuppressive properties of Alemtuzumab + CHOP

  up to five years

• Determine if Fc Receptor-gamma (FcγR) polymorphism is predictive of response or toxicity with Alemtuzumab treatment.

  up to five years

Study Arms (1)

Alemtuzumab/CHOP

EXPERIMENTAL

For all patients enrolled, the study will begin with a stepped-up schedule of single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5. Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose

Drug: CHOP; Drug: Alemtuzumab; Procedure: Plasma Samples

Interventions

CHOP DRUG

CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.

Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone

Alemtuzumab/CHOP

Alemtuzumab DRUG

Single agent Alemtuzumab given subcutaneously (SQ) on week #1. Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1. If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.

Also known as: Humanized monoclonal antibody

Alemtuzumab/CHOP

Plasma Samples PROCEDURE

Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.

Also known as: Pharmacokinetics, Correlative Studies

Alemtuzumab/CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD-20 Negative
• Previous treatment permitted: radiation, electron beam radiotherapy, PUVA, corticosteroids, IFN, low dose methotrexate, retinoids, Ontak
• CNS disease permitted

You may not qualify if:

• Pregnant or Nursing
• prior Alemtuzumab
• history of active Hep C

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Alemtuzumab; Antibodies, Monoclonal, Humanized; Pharmacokinetics

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Pierluigi Porcu, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 9, 2006
• Study Start: March 1, 2004
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)