Trial Outcomes & Findings for Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant (NCT NCT01812252)
NCT ID: NCT01812252
Last Updated: 2024-02-15
Results Overview
18-month failure-free survival (failure defined as death or relapse).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
18 months
Results posted on
2024-02-15
Participant Flow
Participants were recruited based on physician referral at 3 academic medical centers between April 2013 to March 2022. The first participant was enrolled on August 19, 2013 and the last participant was enrolled in September 24, 2021.
This study is a multi-center, open-label randomized study of intensive chemotherapy versus hypomethylating agent-based therapy as the initial pre-transplant cytoreductive therapy in patients with myelodysplastic syndrome. Patients will be randomized to receive treatment with either hypomethylating agent therapy or intensive chemotherapy; they will not receive both.
Participant milestones
| Measure |
Arm A (Decitabine or Azacitidine)
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
Arm A (Decitabine or Azacitidine)
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Persistent Disease
|
1
|
0
|
|
Overall Study
Not transplanted
|
11
|
11
|
|
Overall Study
Transplanted died prior to 18-months post-transplant follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Screen Failure
|
1
|
0
|
Baseline Characteristics
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
59.9 years
n=5 Participants
|
60.7 years
n=7 Participants
|
60.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Number of subjects enrolled and randomized in each arm.
18-month failure-free survival (failure defined as death or relapse).
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Failure-free Survival (Failure Defined as Death or Relapse)
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT).Population: The QLQ-C30 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 22 subjects submitted EORTC QLQ-C30 at screening; 14 subjects completed EORTC QLQ-C30 at pre-transplant and 10 subjects post-transplant. For Arm B (induction chemo) 25 subjects submitted EORTC QLQ-C30 at screening; 13 subjects completed QLQ-C30 at pre-transplant and 10 subjects post-transplant. Scores for each question and timepoints were averaged to obtain mean.
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome.
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities?
|
2.27 score on a scale
Interval 1.0 to 4.0
|
1.72 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities?
|
2.14 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
1.81 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk?
|
2.40 score on a scale
Interval 1.0 to 4.0
|
1.96 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk?
|
1.85 score on a scale
Interval 1.0 to 4.0
|
1.83 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk?
|
1.9 score on a scale
Interval 1.0 to 4.0
|
1.63 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day?
|
1.68 score on a scale
Interval 1.0 to 4.0
|
1.66 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 6. Were you limited in doing either your work or other daily activities?
|
2.22 score on a scale
Interval 1.0 to 4.0
|
1.92 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 6.Were you limited in doing either your work or other daily activities?
|
2.07 score on a scale
Interval 1.0 to 4.0
|
1.61 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-Transplant 6.Were you limited in doing either your work/ other daily activities?
|
1.8 score on a scale
Interval 1.0 to 4.0
|
1.8 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 7.Were you limited in pursing your hobbies or other leisure time activities?
|
2.52 score on a scale
Interval 1.0 to 4.0
|
1.88 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 7.Were you limited in pursing your hobbies/other leisure activities?
|
1.9 score on a scale
Interval 1.0 to 4.0
|
1.8 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 8. Were you short of breath?
|
2.22 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 8. Were you short of breath?
|
1.85 score on a scale
Interval 1.0 to 4.0
|
1.31 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 9. Have you had pain?
|
1.54 score on a scale
Interval 1.0 to 4.0
|
1.48 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 9. Have you had pain?
|
1.78 score on a scale
Interval 1.0 to 4.0
|
1.46 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 9. Have you had pain?
|
1.6 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 10. Did you need to rest?
|
2.38 score on a scale
Interval 1.0 to 4.0
|
2.16 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 10. Did you need to rest?
|
2.21 score on a scale
Interval 1.0 to 4.0
|
2.15 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 10. Did you need to rest?
|
1.9 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 11. Have you had trouble sleeping?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
1.8 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 11. Have you had trouble sleeping?
|
2.35 score on a scale
Interval 1.0 to 4.0
|
1.69 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 11. Have you had trouble sleeping?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
1.6 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 12. Have you felt weak?
|
2.42 score on a scale
Interval 1.0 to 4.0
|
2.04 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 12. Have you felt weak?
|
1.85 score on a scale
Interval 1.0 to 4.0
|
1.77 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 12. Have you felt weak?
|
2.1 score on a scale
Interval 1.0 to 4.0
|
1.7 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 13. Have you lacked appetite?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.70 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 14. Have you felt nauseated?
|
1.31 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 14. Have you felt nauseated?
|
1.07 score on a scale
Interval 1.0 to 4.0
|
1.53 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 14. Have you felt nauseated?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 15. Have you vomited?
|
1.09 score on a scale
Interval 1.0 to 4.0
|
1.12 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 15. Have you vomited?
|
1 score on a scale
Interval 1.0 to 4.0
|
1.08 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 15. Have you vomited?
|
1.1 score on a scale
Interval 1.0 to 4.0
|
1.1 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 16. Have you been constipated?
|
1.31 score on a scale
Interval 1.0 to 4.0
|
1.52 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 16. Have you been constipated?
|
1.21 score on a scale
Interval 1.0 to 4.0
|
1.38 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 16. Have you been constipated?
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 17. Have you had diarrhea?
|
1.45 score on a scale
Interval 1.0 to 4.0
|
1.20 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 18. Were you tired?
|
2.45 score on a scale
Interval 1.0 to 4.0
|
2.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 18. Were you tired?
|
2.10 score on a scale
Interval 1.0 to 4.0
|
2.20 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 19. Did pain interfere with your daily activities?
|
1.61 score on a scale
Interval 1.0 to 4.0
|
1.38 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 26.Has your physical condition/medical treatment interfere w/family?
|
2.15 score on a scale
Interval 1.0 to 4.0
|
2.07 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.24 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house?
|
1.42 score on a scale
Interval 1.0 to 4.0
|
1.30 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house?
|
1.1 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day?
|
1.42 score on a scale
Interval 1.0 to 4.0
|
1.30 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day?
|
1.45 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Screening 5. Do you need help with eating, dressing, washing yourself?
|
1.04 score on a scale
Interval 1.0 to 4.0
|
1.08 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Pre-transplant 5. Do you need help with eating, dressing, washing yourself?
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 at Post-transplant 5. Do you need help with eating, dressing, washing yourself?
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 7.Were you limited in pursing your hobbies/other leisure activities?
|
2.07 score on a scale
Interval 1.0 to 4.0
|
1.85 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 8. Were you short of breath?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.33 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 13. Have you lacked appetite?
|
1.54 score on a scale
Interval 1.0 to 4.0
|
1.72 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 13. Have you lacked appetite?
|
1.71 score on a scale
Interval 1.0 to 4.0
|
1.85 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 17. Have you had diarrhea?
|
1.23 score on a scale
Interval 1.0 to 4.0
|
1.23 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 17. Have you had diarrhea?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 19. Did pain interfere with your daily activities?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 20. Difficulty concentrating on things like reading a or watching TV?
|
1.81 score on a scale
Interval 1.0 to 4.0
|
1.32 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 20. Difficulty concentrating on things like reading a or watching TV?
|
1.69 score on a scale
Interval 1.0 to 4.0
|
1.30 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 20. Difficulty concentrating on things like reading a or watching TV?
|
1.3 score on a scale
Interval 1.0 to 4.0
|
1.2 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 21. Did you feel tense?
|
1.72 score on a scale
Interval 1.0 to 4.0
|
1.60 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 pre-transplant 21. Did you feel tense?
|
1.92 score on a scale
Interval 1.0 to 4.0
|
1.31 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 21. Did you feel tense?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.4 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 22. Did you worry?
|
2.13 score on a scale
Interval 1.0 to 4.0
|
1.68 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 22. Did you worry?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
1.92 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 22. Did you worry?
|
1.8 score on a scale
Interval 1.0 to 4.0
|
1.7 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 23. Did you feel irritable?
|
1.63 score on a scale
Interval 1.0 to 4.0
|
1.41 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-Transplant 23. Did you feel irritable?
|
1.77 score on a scale
Interval 1.0 to 4.0
|
1.54 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-Transplant 23. Did you feel irritable?
|
1.7 score on a scale
Interval 1.0 to 4.0
|
1.6 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 24. Did you feel depressed?
|
1.68 score on a scale
Interval 1.0 to 4.0
|
1.48 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-Transplant 24. Did you feel depressed?
|
1.41 score on a scale
Interval 1.0 to 4.0
|
1.46 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-Transplant 24. Did you feel depressed?
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 25. Have you had difficulty remembering things?
|
1.86 score on a scale
Interval 1.0 to 4.0
|
1.60 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 25. Have you had difficulty remembering things?
|
1.84 score on a scale
Interval 1.0 to 4.0
|
1.54 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 25. Have you had difficulty remembering things?
|
1.9 score on a scale
Interval 1.0 to 4.0
|
1.6 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 26. Has your physical condition/medical treatment interfere with family?
|
1.90 score on a scale
Interval 1.0 to 4.0
|
1.48 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 26.Has your physical condition/medical treatment interfere w/family?
|
1.8 score on a scale
Interval 1.0 to 4.0
|
1.7 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 27.Has your physical condition/medical treatment interfere w/social life?
|
2.09 score on a scale
Interval 1.0 to 4.0
|
1.92 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30Pre-transplant 27.Has your physical condition/medical treatment interfere w/social life?
|
2.5 score on a scale
Interval 1.0 to 4.0
|
2.38 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-trans 27.Has your physical condition/medical treatment interfere w/social life?
|
2.1 score on a scale
Interval 1.0 to 4.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 28.Physical condition/medical treatment caused financial difficulties?
|
1.71 score on a scale
Interval 1.0 to 4.0
|
1.56 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 28.Physical condition/medical treatment caused financial difficulties?
|
2.38 score on a scale
Interval 1.0 to 4.0
|
1.92 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Posttransplant 28.Physical condition/medical treatment caused financial difficulties?
|
2.0 score on a scale
Interval 1.0 to 4.0
|
2.0 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 29.How would you rate your overall health during the past week?
|
4.52 score on a scale
Interval 1.0 to 7.0
|
4.86 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 29.How would you rate your overall health during the past week?
|
4.77 score on a scale
Interval 1.0 to 7.0
|
4.61 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Post-transplant 29.How would you rate your overall health during the past week?
|
5.4 score on a scale
Interval 1.0 to 7.0
|
5.1 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 30. How would you rate your overall quality of life during the past week?
|
4.5 score on a scale
Interval 1.0 to 7.0
|
5.12 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pretransplant 30.How would you rate your overall quality of life during the past week?
|
4.46 score on a scale
Interval 1.0 to 7.0
|
4.69 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Posttransplant 30.How would you rate your overall QoL during the past week?
|
5.1 score on a scale
Interval 1.0 to 7.0
|
5.1 score on a scale
Interval 1.0 to 7.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Pre-transplant 18. Were you tired?
|
2.23 score on a scale
Interval 1.0 to 4.0
|
2.31 score on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
EORTCQLQ-C30 Screening 19. Did pain interfere with your daily activities?
|
1.27 score on a scale
Interval 1.0 to 4.0
|
1.48 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT).Population: The QLQ-HDC29 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 14 subjects submitted EORTC QLQ-HDC29 at pre-HCST and 10 subjects post-HSCT. For Arm B (induction chemo) 13 subjects submitted QLQ-HDC29 at pre-HSCT and 10 subjects post-HSCT. Scores for each question and timepoints were averaged to obtain mean. However, there are some questions were subjects noted N/A and these answered were subtracted from the number analyzed.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome.
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 42. Have you found it difficult to finish things you started?
|
1.64 units on a scale
Interval 1.0 to 4.0
|
1.46 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 47. How satisfied were you with the preparation for your treatment?
|
2.33 units on a scale
Interval 1.0 to 4.0
|
2.83 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth?
|
1.36 units on a scale
Interval 1.0 to 4.0
|
1.08 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth?
|
1.2 units on a scale
Interval 1.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth?
|
1.36 units on a scale
Interval 1.0 to 4.0
|
1.62 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth?
|
2.0 units on a scale
Interval 1.0 to 4.0
|
1.7 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing?
|
1.07 units on a scale
Interval 1.0 to 4.0
|
1.15 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing?
|
1.2 units on a scale
Interval 1.0 to 4.0
|
1.3 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual?
|
1.57 units on a scale
Interval 1.0 to 4.0
|
1.92 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual?
|
1.9 units on a scale
Interval 1.0 to 4.0
|
2.2 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps?
|
1.21 units on a scale
Interval 1.0 to 4.0
|
1.38 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps?
|
1.3 units on a scale
Interval 1.0 to 4.0
|
1.6 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems?
|
1.71 units on a scale
Interval 1.0 to 4.0
|
1.38 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 36. Have you had skin problems?
|
1.6 units on a scale
Interval 1.0 to 4.0
|
1.5 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 37. Have you been upset by how the treatment has affected your hair?
|
1.43 units on a scale
Interval 1.0 to 4.0
|
1.38 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 37. Have you been upset by how the treatment has affected your hair?
|
2.0 units on a scale
Interval 1.0 to 4.0
|
1.7 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 38. Have you worried about your weight being too low?
|
1.5 units on a scale
Interval 1.0 to 4.0
|
1.62 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 38. Have you worried about your weight being too low?
|
1.6 units on a scale
Interval 1.0 to 4.0
|
2.2 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 39. Have you had fevers or chills?
|
1.43 units on a scale
Interval 1.0 to 4.0
|
1.46 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 39. Have you had fevers or chills?
|
1.3 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 40. Did you urinate frequently?
|
2.29 units on a scale
Interval 1.0 to 4.0
|
2.0 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 40. Did you urinate frequently?
|
2.1 units on a scale
Interval 1.0 to 4.0
|
1.4 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 41. Have you had aches or pains in your bones?
|
1.79 units on a scale
Interval 1.0 to 4.0
|
1.46 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 41. Have you had aches or pains in your bones?
|
1.7 units on a scale
Interval 1.0 to 4.0
|
1.4 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 42. Have you found it difficult to finish things you started?
|
1.6 units on a scale
Interval 1.0 to 4.0
|
1.3 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 43. Did you worry about the results of examinations and tests?
|
1.92 units on a scale
Interval 1.0 to 4.0
|
1.66 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 43. Did you worry about the results of examinations and tests?
|
1.7 units on a scale
Interval 1.0 to 4.0
|
1.7 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 44. Have you had trouble coping with the hospital stay?
|
1.6 units on a scale
Interval 1.0 to 4.0
|
1.5 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 44. Have you had trouble coping with the hospital stay?
|
1.0 units on a scale
Interval 1.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 45. Has the isolation in the hospital troubled you?
|
1.66 units on a scale
Interval 1.0 to 4.0
|
1.66 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 45. Has the isolation in the hospital troubled you?
|
1.0 units on a scale
Interval 1.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 46. Have you worried that the blood counts may not recover?
|
2.0 units on a scale
Interval 1.0 to 4.0
|
1.83 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 46. Have you worried that the blood counts may not recover?
|
1.5 units on a scale
Interval 1.0 to 4.0
|
3.33 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 47. How satisfied were you with the preparation for your treatment?
|
2.5 units on a scale
Interval 1.0 to 4.0
|
2.5 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT 48. Have you felt isolated from those close to you (family, friends)?
|
1.77 units on a scale
Interval 1.0 to 4.0
|
1.77 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Post-HSCT 48. Have you felt isolated from those close to you (family, friends)?
|
1.7 units on a scale
Interval 1.0 to 4.0
|
1.6 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC 29 Pre-HSCT49.Have you been concerned about disruption to your family life due to treatment?
|
1.92 units on a scale
Interval 1.0 to 4.0
|
2.23 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29Post HSCT 49.Have you been concerned about disruption to your family life due to treatment?
|
1.5 units on a scale
Interval 1.0 to 4.0
|
2.22 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre HSCT 50. How distressing do you think your illness/treatment has been to those close?
|
2.62 units on a scale
Interval 1.0 to 4.0
|
2.69 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 50. How distressing do you think your illness/treatment has been to those close?
|
2.6 units on a scale
Interval 1.0 to 4.0
|
2.5 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 51. Have you felt a need to keep fears/concerns from family or friends?
|
1.62 units on a scale
Interval 1.0 to 4.0
|
1.84 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 51. Have you felt a need to keep fears/concerns from family or friends?
|
1.8 units on a scale
Interval 1.0 to 4.0
|
2.2 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
Pre-HSCT 52.Has your experience helped u distinguish between important/non-important things in life?
|
2.83 units on a scale
Interval 1.0 to 4.0
|
2.54 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
PostHSCT 52.Has your experience helped u distinguish between important/non-important things in life?
|
2.1 units on a scale
Interval 1.0 to 4.0
|
3.1 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 53. Were you worried about your health in the future?
|
2.23 units on a scale
Interval 1.0 to 4.0
|
2.46 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 53. Were you worried about your health in the future?
|
2.5 units on a scale
Interval 1.0 to 4.0
|
2.5 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 54. Have you felt physically less attractive due to illness/treatment?
|
2.0 units on a scale
Interval 1.0 to 4.0
|
1.92 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 54. Have you felt physically less attractive due to illness/treatment?
|
2.4 units on a scale
Interval 1.0 to 4.0
|
2.1 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 55. Have you been concerned about your ability to have children?
|
1.75 units on a scale
Interval 1.0 to 4.0
|
1.25 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 55. Have you been concerned about your ability to have children?
|
1.33 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 56. Did having to take your drugs regularly interfere with your daily life?
|
1.28 units on a scale
Interval 1.0 to 4.0
|
1.88 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 56. Did having to take your drugs regularly interfere with your daily life?
|
1.9 units on a scale
Interval 1.0 to 4.0
|
2.11 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 57. Have you been watching yourself closely for any new symptoms?
|
2.66 units on a scale
Interval 1.0 to 4.0
|
2.77 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 57. Have you been watching yourself closely for any new symptoms?
|
3.3 units on a scale
Interval 1.0 to 4.0
|
3.66 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 58. Have you felt less interest in sex?
|
2.33 units on a scale
Interval 1.0 to 4.0
|
2.55 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 58. Have you felt less interest in sex?
|
2.50 units on a scale
Interval 1.0 to 4.0
|
2.25 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Pre-HSCT 59. Have you felt less sexual enjoyment?
|
2.16 units on a scale
Interval 1.0 to 4.0
|
2.66 units on a scale
Interval 1.0 to 4.0
|
|
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
QLQ-HDC29 Post-HSCT 59. Have you felt less sexual enjoyment?
|
2.6 units on a scale
Interval 1.0 to 4.0
|
2.25 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Up to 18 monthsThe total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Survival
Participants alive after 18 months from start of treatment who received HCT.
|
7 Participants
|
10 Participants
|
|
Overall Survival
Participants alive after 18months from start of treatment who did not receive HCT.
|
2 Participants
|
1 Participants
|
|
Overall Survival
Participants deceased after 18 months from start of treatment who received HCT.
|
5 Participants
|
3 Participants
|
|
Overall Survival
Participants deceased after 18 months from start of treatment who did not receive HCT.
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Only participants who received a HCT that relapse were assessed for this outcome.
To compare which of the two, intensive chemotherapy versus hypomethylating agent-based therapy, have a factor of relapse post hematopoietic cell transplantation (HCT).
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=12 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=13 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Patients Who Relapse Post-transplant
Relapse post HCT
|
6 Participants
|
3 Participants
|
|
Number of Patients Who Relapse Post-transplant
Did not relapse post HCT
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsFrequency at which the participants received a hematopoietic cell transplantation (HCT)
Outcome measures
| Measure |
Arm A (Decitabine or Azacitidine)
n=25 Participants
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Induction-like Chemotherapy Regimen)
n=25 Participants
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT).
Received hematopoietic cell transplantation
|
12 Participants
|
13 Participants
|
|
Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT).
Did not receive hematopoietic cell transplantation
|
13 Participants
|
12 Participants
|
Adverse Events
Arm A (Decitabine or Azacitidine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Arm B (Induction-like Chemotherapy Regimen)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place