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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00142181

Enrollment

Registered

2005-09-02

Start date

2003-03-31

Completion date

2008-06-30

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoplasmacytic Lymphoma, Waldenstrom's Macroglobulinemia

Keywords

Lymphoplasmacytic lymphoma, Waldenstrom's Macroglobulinemia, Antibody, Campath-1H

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.

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.

Interventions

DRUGCampath-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To determine the safety of Campath-1H.	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026