Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
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|ClinicalTrials.gov Identifier: NCT01538472|
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma|
|Study Start Date :||September 2003|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
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.
- 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.
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): 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|