NCT00142181

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

2.6 years

First QC Date

September 1, 2005

Last Update Submit

December 19, 2012

Conditions

Lymphoplasmacytic LymphomaWaldenstrom's Macroglobulinemia

Keywords

Lymphoplasmacytic lymphomaWaldenstrom's MacroglobulinemiaAntibodyCampath-1H

Outcome Measures

Primary Outcomes (1)

  • To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.

    2 years

Secondary Outcomes (1)

  • To determine the safety of Campath-1H.

    2 years

Study Arms (1)

Campath-1H

EXPERIMENTAL

30 mg IV three times a week, 6-12 weeks.

Drug: Campath-1H

Interventions

Campath-1HDRUG

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.

Campath-1H

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Isreal Deaconness Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-farber Cancer Insitiute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Treon SP, Soumerai JD, Hunter ZR, Patterson CJ, Ioakimidis L, Kahl B, Boxer M. Long-term follow-up of symptomatic patients with lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia treated with the anti-CD52 monoclonal antibody alemtuzumab. Blood. 2011 Jul 14;118(2):276-81. doi: 10.1182/blood-2011-02-338558. Epub 2011 May 12.

    PMID: 21566092RESULT

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneWaldenstrom Macroglobulinemia

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Steven P. Treon, MD, MA, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

March 1, 2003

Primary Completion

October 1, 2005

Study Completion

June 1, 2008

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

US(3)