At a glance
ClinicalIndex Comparison Record- ✓Age ≥50 years with hematologic malignancies treatable by mixed chimera allogeneic HCT
- ✓Patients ≤50 years with hematologic malignancies treatable with mixed chimera HCT who have pre-existing medical conditions or prior therapy placing them at high risk for regimen-related toxicity
- ✓Indolent NHL, CLL, or Hodgkin's disease in advanced stage—must have received and failed front-line therapy
- ✓Multiple myeloma Stage II or III—must have received prior chemotherapy; consolidation after prior autografting permitted
- ✕Rapidly progressive intermediate or high-grade NHL
- ✕Uncontrolled CNS involvement with disease
- ✕Fertile men
- ✕Women unwilling to use contraceptive techniques during and for 12 months following treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating non-myeloablative hematopoietic cell transplantation, Anti-Thymocyte Globulin, and 7 other interventions for Blood Cancer and 7 related conditions. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).
Study Details
Timeline
Interventions
TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.
1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.
6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).
15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.
16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells
1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation
650 mg PO, 30 minutes prior to infusion Pain reliever
50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms
100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin