A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
NCT ID: NCT00001271
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
1991-07-31
2001-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
NCT00007956
BL22 Immunotoxin in Treating Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
NCT00024115
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
NCT05444322
A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
NCT05091541
Administration of T Lymphocytes for Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma (CART CD30)
NCT01316146
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IgG-RFB4-SMPT-dgA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vitetta ES, Fulton RJ, May RD, Till M, Uhr JW. Redesigning nature's poisons to create anti-tumor reagents. Science. 1987 Nov 20;238(4830):1098-104. doi: 10.1126/science.3317828.
Thorpe PE, Detre SI, Foxwell BM, Brown AN, Skilleter DN, Wilson G, Forrester JA, Stirpe F. Modification of the carbohydrate in ricin with metaperiodate-cyanoborohydride mixtures. Effects on toxicity and in vivo distribution. Eur J Biochem. 1985 Feb 15;147(1):197-206. doi: 10.1111/j.1432-1033.1985.tb08737.x.
Shen GL, Li JL, Ghetie MA, Ghetie V, May RD, Till M, Brown AN, Relf M, Knowles P, Uhr JW, et al. Evaluation of four CD22 antibodies as ricin A chain-containing immunotoxins for the in vivo therapy of human B-cell leukemias and lymphomas. Int J Cancer. 1988 Nov 15;42(5):792-7. doi: 10.1002/ijc.2910420527.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
91-C-0176
Identifier Type: -
Identifier Source: secondary_id
910176
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.