A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00001271
• Date of registration: 03/11/1999
• Primary sponsor: National Cancer Institute (NCI)
• Public title: A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
• Scientific title: A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
• Date of first enrolment: July 1991
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001271
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Patients with a histologic diagnosis confirmed from a pretreatment biopsy at the
Laboratory of Pathology, NCI of one of the following entities: Diffuse small Lymphocytic
Lymphoma; Follicular, Small Cleaved cell Lymphoma; Follicular, Mixed Small Cleaved and
Large Cell Lymphoma; Follicular Large Cell Lymphoma; Diffuse, Intermediately
Differentiated Lymphocytic Lymphoma; Diffuse, Small Cleaved Cell Lymphoma; Diffuse,
Mixed Small and Large Cell Lymphoma; Diffuse, Large Cell Lymphoma; Large Cell
Immunoblastic Lymphoma; Small Noncleaved Cell Lymphoma.

Presence of CD22 antigen on at least 30 percent of tumor cells.

Presence of objectively measurable sites of disease. Bone marrow positivity and
circulating tumor cells in the peripheral blood will be considered evaluable but not
measurable disease.

No patients with purely B-cell Lymphosarcoma cell leukemia without nodal or soft tissue
involvement.

No patients with B-cell chronic lymphocytic leukemia, or B-cell or pre-B-cell acute
lymphocytic leukemia, and hairy cell leukemia.

Patients with objectively measurable disease outside a radiation port or disease which has
clearly progressed within a radiation port.

HIV negative.

No CNS disease.

No pulmonary parenchymal disease.

Pleural effusions or ascites may be present.

Patients with progression of disease despite at least one standard combination
chemotherapy regimen.

No chemotherapy for at least two weeks prior to entry.

Patients who do not desire or are not candidates for autologous or allogeneic bone marrow
transplantation procedures.

Life expectancy of at least 3 months

Creatinine clearance greater than 60 cc per minute.

Total bilirubin less than 1.5 mg/dl.

SGPT less than 2 times the upper limit of normal.

Albumin greater than 75 percent of the lower limit of normal.

If prior treatment with doxorubicin, the radionuclide or echocardiogram ejection fraction
shall be at least 35 percent.

Performance status 0-2.

Not in need of current radiation therapy to alleviate local problems.

No prior exposure to murine antibodies.

No need for current corticosteroid treatment.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

B Cell Lymphoma

Intervention(s)

Drug: IgG-RFB4-SMPT-dgA

Secondary ID(s)

91-C-0176

910176

Source(s) of Monetary Support

Please refer to primary and secondary sponsors