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

Phase 2
18 Years
80 Years
Not Enrolling
Lymphoplasmacytic Lymphoma, Waldenstrom's Macroglobulinemia

Thank you

Trial Information

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

- 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.

Inclusion Criteria:

- Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven P. Treon, MD, MA, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2003

Completion Date:

June 2008

Related Keywords:

  • Lymphoplasmacytic Lymphoma
  • Waldenstrom's Macroglobulinemia
  • Lymphoplasmacytic lymphoma
  • Waldenstrom's Macroglobulinemia
  • Antibody
  • Campath-1H
  • Lymphoma
  • Waldenstrom Macroglobulinemia



Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-farber Cancer Insitiute Boston, Massachusetts  02115
Beth Isreal Deaconness Medical Center Boston, Massachusetts  02115