Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

December 19, 2012 updated by: Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute

Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
  • After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
  • If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
  • If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
  • No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
  • While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Beth Isreal Deaconness Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-farber Cancer Insitiute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
  • Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
  • Age greater than 18 years
  • Life expectancy of 6 months or greater
  • ECOG performance status of 0-2

Exclusion Criteria:

  • Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
  • Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
  • Pregnant women
  • Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Campath-1H
30 mg IV three times a week, 6-12 weeks.
Drug: Campath-1H
Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of Campath-1H.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Bayer
University of California, Los Angeles
Northwestern University
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Arizona Oncology Associates

Investigators

  • Principal Investigator: Steven P. Treon, MD, MA, PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoplasmacytic Lymphoma

Clinical Trials on Campath-1H

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe