Clinical trial · Interventional
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual.
Summary
Brief summary (as posted)
Primary Objectives: 1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL). 2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL. 3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H. 4. To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.
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 (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCNU | Drug | Carmustine | ALIAS |
| Campath | Drug | Alemtuzumab | ALIAS |
| Campath-1H | Drug | Alemtuzumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| GM-CSF | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Campath-1H
- description
- 3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0. Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.) Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
- interventionNames
- Drug: Campath-1H
- Drug: G-CSF
- Drug: GM-CSF
- Drug: BCNU
- Drug: Stem Cell Transplant
- Drug: Preparative Regimen for Allogenic Stem Cell Transplantation
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Melphalan
- Drug: Campath
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Radiation: Low dose total body irradiation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be less then 70 years old. * Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered. * Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if International Prognostic Index (IPI) is 0-1, or unrelated transplant if IPI is \> 1. Exclusion Criteria: * Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.
References
Publications (0)
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