Trial Outcomes & Findings for Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (NCT NCT03342196)
NCT ID: NCT03342196
Last Updated: 2025-12-03
Results Overview
Leukemia Free Survival (LFS) at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 1 year after transplant
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Thiotepa + Fludarabine + Melphalan
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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|---|---|
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Overall Study
STARTED
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40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Thiotepa + Fludarabine + Melphalan
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation
Baseline characteristics by cohort
| Measure |
Thiotepa + Fludarabine + Melphalan
n=40 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Age, Customized
10-19
|
1 Participants
n=3 Participants
|
|
Age, Customized
20-29
|
4 Participants
n=3 Participants
|
|
Age, Customized
30-39
|
7 Participants
n=3 Participants
|
|
Age, Customized
40-49
|
3 Participants
n=3 Participants
|
|
Age, Customized
50-59
|
12 Participants
n=3 Participants
|
|
Age, Customized
60-69
|
12 Participants
n=3 Participants
|
|
Age, Customized
70-79
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after transplantPopulation: 1 participant was non evaluable for this measure
Leukemia Free Survival (LFS) at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=38 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Percentage of Patients With Disease Free Survival
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65.8 percentage of paticipants
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PRIMARY outcome
Timeframe: Up to 1 year after transplantPopulation: Trial changes eligibility amended to include other hematological diseases - of the 40 pts on study - 39 went to treatment, 1 on treatment non evaluable, and only 29 had Leukemia (ALL/CML/CMML and AML)
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=29 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Percentage of Patients With Leukemia Free Survival
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65.5 percentage of paticipants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 1 participant was non evaluable for this measure
Overall Survival (OS) at 1 year is the percentage of patients alive at 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=38 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Average Overall Survival
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73.7 percentage of participants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 9 participants were non evaluable for this measure
Relapse incidence at 1 year is the percentage of patients who experience relapse of their hematologic malignancy up to 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=30 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Relapse Incidence
|
13.16 percentage of participants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 1 participant was non evaluable for this measure
Treatment Related Mortality (TRM) at 1 year is the percentage of patients who expire from treatment related toxicity attributed to transplant up to 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=38 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Treatment Related Mortality
|
21.05 percentage of paticipants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 1 participant was non evaluable for this measure
Acute graft versus host disease (aGVHD) 1 year cumulative incidence is the percentage of patients who experience any aGVHD up to 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=38 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Incidence of Acute GVHD
|
76.31 percentage of participants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 1 participant was non evaluable for this measure
Chronic graft versus host disease (cGVHD) 1-year cumulative incidence is the percentage of patients who experience any cGVHD up to 1 year after transplant.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=38 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Incidence of Chronic GVHD
|
21.05 percentage of participants
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 4 participants were non evaluable for this measure
Neutrophil engraftment will be calculated as the days from transplant where the absolute neutrophil count (ANC) reaches \>500cells/ul x 3 days.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=35 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Rate of Neutrophil Engraftment
|
20.6 Days
Standard Deviation 5.69
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SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: 5 participants were non evaluable for this measure
Platelet engraftment will be calculated as the days from transplant where the platelet count reaches 20,000 platelets /ul without the need of transfusion of platelets for 7 days.
Outcome measures
| Measure |
Thiotepa + Fludarabine + Melphalan
n=34 Participants
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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Rate of Platelet Engraftment
|
42.32 Days
Standard Deviation 31.4
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Adverse Events
Thiotepa + Fludarabine + Melphalan
Serious events: 18 serious events
Other events: 35 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Thiotepa + Fludarabine + Melphalan
n=40 participants at risk
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
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|---|---|
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Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Encephalitis infection
|
2.5%
1/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Enterocolitis infectious
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Heart failure
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
2.5%
1/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Fungemia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
4/40 • Number of events 10 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Multi-organ failure
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Number of events 6 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
2.5%
1/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Syncope
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
Other adverse events
| Measure |
Thiotepa + Fludarabine + Melphalan
n=40 participants at risk
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Melphalan: Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Thiotepa: Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash.
Fludarabine: Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
|
|---|---|
|
Psychiatric disorders
Delirium
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Catheter related infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Chills
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Colitis
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Psychiatric disorders
Confusion
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Creatinine increased
|
10.0%
4/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Immune system disorders
Cytokine release syndrome
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
6/40 • Number of events 10 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.0%
6/40 • Number of events 9 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Immune system disorders
Allergic reaction
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Anorectal infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
8/40 • Number of events 11 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Bacteremia
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Renal and urinary disorders
Bladder spasm
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
10/40 • Number of events 17 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Edema limbs
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Encephalitis infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Enterocolitis infectious
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Eye disorders
Eye infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Fatigue
|
15.0%
6/40 • Number of events 10 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Fever
|
25.0%
10/40 • Number of events 17 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Fungemia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Generalized edema
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.5%
3/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Heart failure
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Vascular disorders
Hematoma
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Herpes simplex reactivation
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
4/40 • Number of events 6 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Vascular disorders
Hypertension
|
25.0%
10/40 • Number of events 16 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
7.5%
3/40 • Number of events 6 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
4/40 • Number of events 6 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Investigations - Other, specify
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Kidney infection
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Localized edema
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Lung infection
|
7.5%
3/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
5/40 • Number of events 9 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Multi-organ failure
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Nausea
|
27.5%
11/40 • Number of events 15 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Oral pain
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Pain
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Paresthesia
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Reproductive system and breast disorders
Perineal pain
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
7.5%
3/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
4/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Rectal pain
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Sepsis
|
5.0%
2/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Serum amylase increased
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
2.5%
1/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Skin infection
|
7.5%
3/40 • Number of events 5 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
General disorders
Sudden death NOS
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Syncope
|
10.0%
4/40 • Number of events 4 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Vascular disorders
Thromboembolic event
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Thrush
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
2/40 • Number of events 2 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
1/40 • Number of events 1 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 3 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Infections and infestations
Viremia
|
2.5%
1/40 • Number of events 5 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
6/40 • Number of events 7 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
Weight loss
|
10.0%
4/40 • Number of events 5 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
|
Investigations
White blood cell decreased
|
2.5%
1/40 • Number of events 6 • Participants were followed for this study for 1 year following the allogeneic transplant, relapse, or death, whichever occured first.
|
Additional Information
Principle Investigator
University Hospitals, Case Comprehensive Cancer Center
Phone: 216-844-0139
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place