NCT00107614

DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients

UARK 2002-10, A Phase II Study of DT PACE Induction, Followed by Tandem Autologous Transplant and Maintenance Therapy for Patients With Advanced and/or Symptomatic Waldenstrom's Macroglobulinemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants.

Detailed description

Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only. Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	DT PACE + Rituxan	INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with \< 50% response to induction) OR MEL-DT PACE (Patients with \> 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year

Timeline

• Start date: 2002-11-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-04-06
• Last updated: 2011-08-26
• Results posted: 2011-07-15

Locations

1 site across 1 country: United States