Clinical trial · Interventional
Non-Myeloablative Allogeneic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma
NCT00525876CI-TRIAL-00005881completedN/AResults postedClinicalTrials.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)
1. To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma. 2. To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Allogeneic Stem Cell Infusion | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Matched Sibling Transplant
- description
- Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Rituximab
- Procedure: Allogeneic Stem Cell Infusion
- type
- EXPERIMENTAL
- label
- Allo MUD & MM
- description
- Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients can be as old as 70 years. 2. They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B\^2 microglobulin (\> 3). 3. Patients that have received prior conventional chemotherapy but have not achieved complete response (CR). 4. Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy). 5. Patients whose disease failed to respond to a previous autologous transplantation may also be eligible. 6. Patients must have a matched or 1 antigen mismatched sibling or unrelated donor. 7. Point Scale (PS) \</= 2. 8. Inclusion criteria for Immunomodulation Post transplantation: Patients can be as old as 70 years. Patients must have a diagnosis of MCL or CLL with one of the following characteristics: 1. Patients who develop disease progression or do not experience a CR within 3 months post-allogeneic transplantation 2. Patients with a weak chimerism (any mixed chimerism of donor T cells in patients receiving Campath by day 90, and less than 20% for patients not receiving Campath) or a drop of 20% or more with an amount of donor cells present in the blood \< 50% by PCR . 9. Continued from Inclusion # 8: Patients must have the same donor of the original transplant willing to donate lymphocytes. 4. PS \</ 2. Exclusion Criteria: 1. Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies. 2. Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen. 3. Pregnancy or lactation. 4. HIV or HTLV-I positivity. 5. Serum creatinine concentration \> 1.6 mg/dl or serum bilirubin \> 2.0 mg/dl unless due to tumor 6. pulmonary function test - carbon monoxide diffusing capacity \< 40% 7. cardiac ejection fraction \< 40% of predicted levels (by multiple-gated acquisition or echocardiography). 8. Severe concomitant medical or psychiatric illness.
References
Publications (0)
Data not yet available
No reference posted for this study.