Clinical trial · Interventional
Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkin's Lymphoma
A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide
- 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: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkin's 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| LMB-2 immunotoxin | Biological | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
Secondary outcomes (5)
- measure
- Response rate
- measure
- Response duration
- measure
- Correlation of serum levels of LMB-2 immunotoxin with toxicity and response
- measure
- Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity
- measure
- Correlation of soluble Tac-peptide with treatment response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histopathologically confirmed CD25+ Hodgkin's lymphoma * At least 20% of the malignant cells positive by immunohistochemistry * Stage II-IV disease * Meets the following criteria: * Failed standard chemotherapy * Not eligible for curative salvage radiotherapy or chemotherapy * Not eligible for or refused bone marrow transplantation * Measurable disease * No patient whose serum neutralizes LMB-2 immunotoxin in tissue culture, due either to antitoxin or antimouse-IgG antibodies * No patient whose serum neutralizes \> 75% of the activity of 1 µg/mL of LMB-2 immunotoxin PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * ALT and AST ≤ 2.5 times upper limit of normal * Albumin ≥ 3.0 g/dL * Bilirubin ≤ 2.2 mg/dL (\< 5 mg/dL if Gilbert's syndrome is present) * Creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situations that would limit study compliance * No HIV or hepatitis C positivity * Hepatitis B surface antigen positivity allowed provided patient is receiving lamivudine * LVEF ≥ 45% * DLCO ≥ 50% of normal OR FEV\_1 ≥ 60% of normal * No active second malignancy requiring treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No systemic cytotoxic chemotherapy within the past 4 weeks * No systemic steroids (except stable doses of prednisone ≤ 20 mg/day) within the past 4 weeks * No monoclonal antibody therapy within the past 12 weeks * No prior LMB-2 immunotoxin * No concurrent warfarin
References
Publications (0)
Data not yet available