DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients
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|ClinicalTrials.gov Identifier: NCT00107614|
Recruitment Status : Terminated (Terminated due to poor accrual.)
First Posted : April 6, 2005
Results First Posted : July 15, 2011
Last Update Posted : August 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom Macroglobulinemia||Drug: DT PACE + Rituxan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: DT PACE/auto transplant/maint therapy||
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
- Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT) [ Time Frame: 3 years ]To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström's Macroglobulinemia (WM), either untreated or previously treated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107614
|United States, Arkansas|
|University of Arkansas for Medical Sciences/MIRT|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, MD, PhD||UAMS|