Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma
NCT00007956CI-TRIAL-00017736completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody mono-dgA-RFB4 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen * Low, intermediate, or high grade * CD22 antigen on at least 30% of tumor cells by flow cytometry * No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia * Measurable disease * Positive bone marrow not considered measurable * Circulating tumor cells in peripheral blood considered measurable * No CNS disease (leptomeningeal or parenchymal) * No lymphomatous or infectious pulmonary parenchymal disease * No baseline/pleural effusion * Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count greater than 50,000/mm\^3 * Absolute granulocyte count greater than 750/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * SGPT less than 2 times upper limit of normal * Albumin greater than 75% lower limit of normal Renal: * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * Ejection fraction greater than 40% by MUGA or echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL * No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction * No other concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 2 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy Radiotherapy: * No prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.