At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of CLL, SLL, or CLL progressing to prolymphocytic leukemia (PLL)
- ✓Failed to meet complete/partial response criteria after 2 cycles of fludarabine (or similar nucleoside analog) therapy, OR disease relapse within 12 months after completing such therapy
- ✓Failed FCR or pentostatin/cyclophosphamide/rituximab (PCR) combination chemotherapy at any time point
- ✓Patients with de novo or acquired 17p deletion cytogenetic abnormality; may be transplanted in first complete remission with prior induction
- ✕HIV infection
- ✕Active CNS involvement with CLL
- ✕Unwilling to use contraception before and for 12 months after HCT
- ✕Pregnant or breastfeeding females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nonmyeloablative Conditioning With Pre- and Post-Transplant Rituximab Followed by Related or Unrelated Donor Hematopoietic Cell Transplantation for Patients With Advanced Chronic Lymphocytic Leukemia: A Multi-Center Trial
In Brief
A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Cyclosporine, and 7 other interventions for Chronic Lymphocytic Leukemia and 8 related conditions. Completed, enrolled 66 participants across 5 sites in 3 countries.
Detailed Summary
This phase II trial studies how well fludarabine phosphate with radiation therapy and rituximab followed by donor stem cell infusions work in treating patients with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with low side effects. Nonmyeloablative stem cell transplants use low doses of chemotherapy (fludarabine phosphate) and radiation to suppress the patient's immune system enough to prevent rejection of the donor's stem cells. Following infusion of donor stem cells, a mixture of the patient's and the donor's stem cells will exist and is called "mixed chimerism". Donor cells will attack the patient's leukemia. This is called the "graft-versus-leukemia" effect. Rituximab will be given 3 days before and three times after infusing stem cells to help in controlling CLL early after transplant till the "graft-versus-leukemia" takes control. Further, rituximab could augment the "graft-versus-leukemia" effect by activating donor immune cells and hence improve disease control. Sometimes the transplanted cells from a donor can also attack the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Study Details
Timeline
Interventions
Undergo HSCT
Given PO
Given IV
Correlative studies
Given PO
Undergo HSCT
Correlative studies
Given IV
Undergo TBI