Trial Outcomes & Findings for Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma (NCT NCT01538472)
NCT ID: NCT01538472
Last Updated: 2014-09-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)
Results posted on
2014-09-11
Participant Flow
Recruitment Period: September 30, 2003 to September 17, 2007. All participants enrolled at the University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
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 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (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.
|
|---|---|
|
Overall Study
Disease Progression
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
Baseline characteristics by cohort
| Measure |
Y Zevalin + BEAM
n=40 Participants
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.
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Y Zevalin + BEAM
n=40 Participants
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.
|
|---|---|
|
Overall Survival Median
|
1299 days
Interval 8.0 to 2017.0
|
PRIMARY outcome
Timeframe: 3 yearsNumber 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.
Outcome measures
| Measure |
Y Zevalin + BEAM
n=40 Participants
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.
|
|---|---|
|
3-Year Overall Survival
|
78 percentage of participants
|
Adverse Events
Y Zevalin + BEAM
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Y Zevalin + BEAM
n=40 participants at risk
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.
|
|---|---|
|
General disorders
Death not related to Common Toxocity Adverse Events (CTCAE)
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
General disorders
Secondary Graft Failure
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Infections and infestations
Infection
|
5.0%
2/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
General disorders
Death due to Septic Shock
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Immune system disorders
Stem cell Infusion Reaction
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
Other adverse events
| Measure |
Y Zevalin + BEAM
n=40 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Alanine Aminotransferase (ALT) Increase
|
30.0%
12/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Gastrointestinal disorders
Mucositis
|
92.5%
37/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Gastrointestinal disorders
Diarrhea
|
72.5%
29/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Infections and infestations
Fever
|
7.5%
3/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Cardiac disorders
Hypotension
|
7.5%
3/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Cardiac disorders
Hypertension
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Gastrointestinal disorders
Nausea
|
72.5%
29/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Metabolism and nutrition disorders
Increased Bilirubin
|
15.0%
6/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase Elevated
|
25.0%
10/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
12.5%
5/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Renal and urinary disorders
Urinary Frequency
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
|
Renal and urinary disorders
Acute renal failure
|
2.5%
1/40 • Adverse event reporting 21 days prior to autologous stem cell transplantation (ASCT) to 8 days post transplant. Overall participation period (inclusive of Y Zevalin, BEAM/Rituximab treatment and ASCT) from March 2004 to November 2011.
|
Additional Information
Issa Khouri, MD / Professor, Stem Cell Transplant
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-2803
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place