Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


OBJECTIVES:

- Determine the objective response in patients with Waldenstrom's macroglobulinemia
treated with alemtuzumab.

- Determine the time to treatment failure in patients treated with this drug.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in
the absence of disease progression or unacceptable toxicity. Patients with a complete
response undergo observation. Patients with stable disease or a minor or partial response
receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

- Immunoglobulin (Ig) M, IgG, and IgA paraprotein

- Measurable monoclonal paraprotein

- Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or
rituximab)

- CD52-positive tumor determined by either bone marrow immunohistochemistry or flow
cytometry

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count ≥ 500/mm^3

- Platelet count ≥ 25,000/mm^3

Hepatic

- SGOT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 2.5 times ULN

Renal

- Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception during and for 6
months after study participation

- No serious comorbid disease

- No uncontrolled bacterial, fungal, or viral infection

- No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior alemtuzumab

- More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

- See Disease Characteristics

- More than 21 days since prior chemotherapy

Endocrine therapy

- More than 21 days since prior steroid therapy

Radiotherapy

- More than 21 days since prior radiotherapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Safety Issue:

No

Principal Investigator

Jennifer Gansert, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000358811

NCT ID:

NCT00081068

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Rocky Mountain Cancer Centers - Denver MidtownDenver, Colorado  80218