Concurrent Fludarabine and Total Body Irradiation (F-TBI) for Patients with Advanced Relapsed, Refractory, or Resistant Indolent Non-Hodgkin's Lymphoma (NHL): A Phase I Trial.
Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 10, 2001
Presenter: David Eilender
Presenter's Affiliation: Wayne State University
Type of Session: Poster
Materials and Methods
- Advanced relapsed, refractory, or resistant indolent NHL.
- Previously treated, but not post-bone marrow or peripheral stem cell transplant.
- Good renal function,absolute neutrophil count and platelet count.
- Good perfomance status
- Criteria for dose-limiting toxicity (DLT) (any of the following 4:
- Plts <20x10(9)(ten-to-the-9th) or an ANC <0.5x10(9) for >10 days.
- Plts not >100x10(9) or ANC not >1.5x10(9) by day 43.
- If bone marrow >30%, then plts not >50x10(9) or ANC >0.8x10(9) for the first 2 cycles, by day 43.
- Maximum tolerated Dose (MTD)
- Maximum dose level RT, with DLT in <3 of 8 patients.
- Treat at least 8 patients at the MTD.
- Only 1 patient died within 30 days of treatment.
- 5 pts died of progressive disease.
- 2 deaths were not evaluable.
- 3 patients died of infection (not neutropenic).
- 10 pts are still alive to date.
- Toxicity of F-TBI was low compared to other salvage therapies, such as bone marrow transplant.
- Aggressive treatment of infections was required.
- This phase I study offers some evidence of efficacy and safety in the treatment of advanced relapsed, refractory, or resistant indolent NHL with F-TBI.
- Further studies with increased numbers of patients and longer follow-up are necessary
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