Comparison of Two Salvage Chemotherapy Regimens Before Autologous Stem Cell Transplantation With or Without Maintenance Rituximab in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00078949|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2004
Results First Posted : October 21, 2014
Last Update Posted : March 12, 2018
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cisplatin Drug: cytarabine Drug: dexamethasone Drug: gemcitabine hydrochloride||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||619 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study Of Gemcitabine, Dexamethasone, And Cisplatin Compared To Dexamethasone, Cytarabine, And Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] As Salvage Chemotherapy For Patients With Relapsed Or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior To Autologous Stem Cell Transplant And Followed By Maintenance Rituximab Versus Observation|
|Study Start Date :||August 2003|
|Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||December 2018|
Experimental: Salvage arm I
Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.
Given IVDrug: dexamethasone
Given IVDrug: gemcitabine hydrochloride
Experimental: Salvage arm II
Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.
Given IVDrug: cytarabine
Given IVDrug: dexamethasone
Experimental: Maintenance arm I
Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.
No Intervention: Maintenance arm II
Patients undergo observation only.
- Response Rate of Patients After 2 Courses of Chemotherapy [ Time Frame: After 2 cycle of treatment ]The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).
- Transplantation Rate of Patients After 2 Courses of Chemotherapy [ Time Frame: During period 1 (salvage chemotherapy) ]Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients
- Event-free Survival of Patients on Maintenance Randomization (Period 2) [ Time Frame: during the period 2 (up to10 years) ]Number of patients who develop EFS event during maintenance randomization (period 2)
- Mobilization Rate of Patients on Treatment Arm I Assessed by CD34 Count After 2 Courses of Therapy and Stem Cell Harvesting [ Time Frame: 10 years ]
- Toxicity Assessed by NCI CTC v2.0 for 2 Years in Patients on Treatment Arm II [ Time Frame: 10 years ]
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): NCT00078949
Show 26 Study Locations
|Study Chair:||Michael R. Crump, MD, FRCPC||Princess Margaret Hospital, Canada|
|Study Chair:||Massimo Federico, MD||Azienda Ospedaliera - Universitaria di Modena|