Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
|Lymphoma||Drug: Y Zevalin Drug: In Zevalin Drug: Rituxan Drug: BCNU Drug: VP -16 Drug: Ara-C Drug: Melphalan Procedure: Stem Cell Infusion Drug: G-CSF||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma|
- Overall Survival Median [ Time Frame: Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration) ]Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.
- 3-Year Overall Survival [ Time Frame: 3 years ]Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.
|Study Start Date:||September 2003|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Y Zevalin + BEAM
Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
G-CSF 5 mg/kg given daily starting Day 0 till recovery of granulocytes of 4.0 * 109/L.
Drug: Y Zevalin
Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.Drug: In Zevalin
Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.Drug: Rituxan
250 mg/m2 by vein on Day -21 and on Day -14.
1000 mg/m2 by vein on Days +1 and +8.
Other Name: RituximabDrug: BCNU
300 mg/m2 by vein on Day -6.
Other Names:Drug: VP -16
200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.Drug: Ara-C
200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.
Other Names:Drug: Melphalan
140 mg/m2 by vein on Day -1.
Other Name: AlkeranProcedure: Stem Cell Infusion
Autologous stem cell infusion on Day 0.Drug: G-CSF
5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538472
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issa F. Khouri, MD,BS||UT MD Anderson Cancer Center|