Clinical trial · Interventional
Safety and Efficacy of Campath in Nonmyeloablative Transplantation
NCT00038844CI-TRIAL-00005712completedN/AClinicalTrials.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)
Objective of the low-dose transplant regimen must produce the following effects: 1. Suppression of the patient's immune system to prevent rejection of the donor cells; 2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campath-1 H (Alemtuzumab) | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Campath in Nonmyeloablative Transplantation
- description
- Campath-1 H Starting Dose of 15 mg by vein daily, 3 days in a row + Fludarabine 30 mg/m2 by vein daily, 3 days in a row + Cyclophosphamide 1 gm/m2 by vein daily, 3 days in a row + Rituximab 375 mg/m2 by vein, given 8 days before transplant then weekly for 4 total doses.
- interventionNames
- Drug: Campath-1 H (Alemtuzumab)
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Rituximab
Primary outcomes (1)
- measure
- Number of Participants Surviving 100 days post-transplant
- timeFrame
- 30 Day Engraftment (Baseline) to 100 Days post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Up to 70 years of age (physiological). 2. Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab). 3. Patients in relapse with a partial remission or stable disease. 4. Patients who failed a prior autologous transplant are also eligible. 5. Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)\<2. 6. Patients are included even if they were previously exposed to Campath or Rituximab. Exclusion Criteria: 1. Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies. 2. Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen. 3. Pregnancy or lactation. 4. HIV or HTLV-I positively. 5. Serum creatinine \>1.6mg/dl or serum bilirubin \>1.5mg/dl unless due to tumor. 6. Pulmonary function tests (PFTs) -OLCO\<50%, cardiac EF \<50% of predicted levels. 7. Patient with severe concomitant medical or psychiatric illness.
References
Publications (0)
Data not yet available
No reference posted for this study.