At a glance
ClinicalIndex Comparison Record- ✓Intermediate- or high-grade NHL in first CR with high-risk features (high age-adjusted IPI, stage III-IV, abnormal LDH) AND mantle cell histology, OR primary refractory NHL, OR NHL beyond first CR
- ✓Low-grade NHL beyond second relapse
- ✓Hodgkin's lymphoma: primary refractory disease or beyond first CR
- ✓Adequate stored autologous PBSCs (≥2.0 × 10⁶ CD34+ cells/kg)
- ✕Active CNS disease
- ✕Prior autologous or allogeneic transplantation
- ✕HIV positive
- ✕Significant active infection that would preclude PBSC transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Evaluate the Safety and Efficacy of IV Busulfan, Melphalan, and Thiotepa (BuMelTT) Followed By Autologous PBSC Infusion for Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma
In Brief
A Phase 2 clinical trial evaluating filgrastim, busulfan, and 4 other interventions for Lymphoma. Completed, enrolled 37 participants across 1 site.
Detailed Summary
RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.
Study Details
Timeline
Interventions
5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days.
3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
250 mg/m2/day/iv on days -3 and -2
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Performed 36-48 hours following last chemotherapy dose.