N/A
N=36
Non-Myeloablative Allogeneic Stem Cell Transplantation
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00525876 ↗Enrolled (actual)
36
Serious AEs
13.9%
Results posted
Dec 2011
Primary outcome: Primary: Overall Survival at 100 Days Post Transplant (Number of Surviving Participants) — 16; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cyclophosphamide (Drug); Fludarabine (Drug); Rituximab (Drug); Alemtuzumab (Drug); Allogeneic Stem Cell Infusion (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 100 Days Post Transplant (Number of Surviving Participants) |
16; 19 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients can be as old as 70 years.
- 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).
- Patients that have received prior conventional chemotherapy but have not achieved complete response (CR).
- Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
- Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
- Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
- Point Scale (PS) 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
- pulmonary function test - carbon monoxide diffusing capacity < 40%
- cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).
- Severe concomitant medical or psychiatric illness.
Data sourced from ClinicalTrials.gov (NCT00525876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.