Trial Outcomes & Findings for All-trans Retinoic Acid, and Arsenic +/- Idarubicin (NCT NCT00413166)
NCT ID: NCT00413166
Last Updated: 2019-05-07
Results Overview
Response defined as CR (marrow with \<5% blasts and no abnormal promyelocytes together with neutrophil count \>1000 and platelet count \>100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy. Bone marrow aspirate performed to check the status of the disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
1 month, up to day 85 of treatment
Results posted on
2019-05-07
Participant Flow
Recruitment Period: December 5, 2006 to April 3, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pfizer withdrew gemtuzumab ozogamycin (GO) from market based Food \& Drug Administration recommendation. As such, protocol modified to Idarubicin Day 1 of induction in high-risk participants \& in low risk participants with rising white blood count (WBC), Idarubicin administered to low-risk patients in whom WBC \>10,000 after initiation of ATRA + ATO.
Participant milestones
| Measure |
ATRA + ATO: Low Risk (WBC<10,000)
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
Post CR
1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.
|
ATRA+ATO+IDA: High Risk (WBC >10,000)
Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.
ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
|
ATO+ATRA+GO
ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.
Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
5
|
16
|
|
Overall Study
COMPLETED
|
57
|
5
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All-trans Retinoic Acid, and Arsenic +/- Idarubicin
Baseline characteristics by cohort
| Measure |
ATRA + ATO: Low Risk (WBC<10,000)
n=57 Participants
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
Post CR
1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.
|
ATRA+ATO+IDA: High Risk (WBC >10,000)
n=5 Participants
Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.
ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
|
ATO+ATRA+GO
n=16 Participants
Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.
Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Age, Continuous
|
49 years
n=99 Participants
|
38 years
n=107 Participants
|
44 years
n=206 Participants
|
47 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=99 Participants
|
5 participants
n=107 Participants
|
16 participants
n=206 Participants
|
78 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 month, up to day 85 of treatmentPopulation: Of the 57 participants treated on the ATRA + ATO: Low Risk treatment arm, 56 participants were evaluable for response.
Response defined as CR (marrow with \<5% blasts and no abnormal promyelocytes together with neutrophil count \>1000 and platelet count \>100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy. Bone marrow aspirate performed to check the status of the disease.
Outcome measures
| Measure |
ATRA + ATO: Low Risk (WBC<10,000)
n=56 Participants
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
Post CR
1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.
|
ATRA+ATO+IDA: High Risk (WBC >10,000)
n=5 Participants
Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.
ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
|
ATO+ATRA+GO
n=16 Participants
Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.
Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
|
|---|---|---|---|
|
Complete Response (CR) Rate
|
55 Participants
|
5 Participants
|
15 Participants
|
Adverse Events
ATRA + ATO: Low Risk (WBC<10,000)
Serious events: 22 serious events
Other events: 5 other events
Deaths: 1 deaths
ATRA+ATO+IDA: High Risk (WBC >10,000)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
ATO+ATRA+GO
Serious events: 4 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ATRA + ATO: Low Risk (WBC<10,000)
n=57 participants at risk
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
Post CR
1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.
|
ATRA+ATO+IDA: High Risk (WBC >10,000)
n=5 participants at risk
Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.
ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
|
ATO+ATRA+GO
n=16 participants at risk
Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.
Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
|
|---|---|---|---|
|
Gastrointestinal disorders
Appendectomy
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Cardiac disorders
Cardiac Troponin I
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Cardiac disorders
Chest Pain
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Nervous system disorders
Depressed level of Consciousness
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Elevated Transaminases
|
1.8%
1/57 • Number of events 2 • Up to 7 years
|
40.0%
2/5 • Number of events 4 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Elevated Amylase
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Elevated Creatinine
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Elevated Lipase
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
General disorders
Fatigue
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
General disorders
Headache
|
15.8%
9/57 • Number of events 13 • Up to 7 years
|
40.0%
2/5 • Number of events 2 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.5%
2/57 • Number of events 2 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/57 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
|
Surgical and medical procedures
Hernia Repair
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Infections and infestations
Infection
|
8.8%
5/57 • Number of events 6 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
18.8%
3/16 • Number of events 3 • Up to 7 years
|
|
Cardiac disorders
Left Ventricular Diastolic Dysfunction
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
General disorders
Death
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/57 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 2 • Up to 7 years
|
|
General disorders
Pain
|
3.5%
2/57 • Number of events 2 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
12.5%
2/16 • Number of events 2 • Up to 7 years
|
|
Nervous system disorders
Peripharal Neuropathy
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Cardiac disorders
Prolonged QTc interval
|
3.5%
2/57 • Number of events 3 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 2 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/57 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Renal and urinary disorders
Renal Insufficiency
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.5%
2/57 • Number of events 2 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
|
Investigations
Retinoic acid syndrome
|
7.0%
4/57 • Number of events 4 • Up to 7 years
|
40.0%
2/5 • Number of events 2 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
|
Nervous system disorders
Sensory Neuropathy
|
1.8%
1/57 • Number of events 1 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
0.00%
0/16 • Up to 7 years
|
Other adverse events
| Measure |
ATRA + ATO: Low Risk (WBC<10,000)
n=57 participants at risk
All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO): Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg by vein (IV) daily beginning day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days. Methylprednisolone 500 mg daily for 5 days followed by rapid taper starting on day 1
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) as needed for WBC\>10,000. 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
Post CR
1.) ATO 0.15 mg/kg IV for 5 of every 7 days on each of weeks 1-4 (course 2), 9-12 (course 3), 17-20 (course 4), and 25-28 (course 5) (thus 4 courses). 2.) Oral ATRA 45 mg/m2 daily on a "2-weeks on -2-weeks off" basis until therapy with ATO completed.
|
ATRA+ATO+IDA: High Risk (WBC >10,000)
n=5 participants at risk
Oral ATRA 45 mg/m2 daily beginning day 1; ATO 0.15 mg/kg IV daily beginning day 1; Idarubicin (IDA) 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days.
ATRA Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1; and ATO: Induction: 0.15 mg/kg daily IV beginning day 1.
Idarubicin: 1) 12 mg/m2 one dose only (day 1 to 5 of induction) 2) If ATRA or ATO discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses administered once every 4- 5 weeks until 28 weeks elapsed from Complete Recovery date.
|
ATO+ATRA+GO
n=16 participants at risk
Induction ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1 ATO 0.15 mg/kg IV daily beginning on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1 GO 9 mg/m2 on day 1 of induction Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.
Post-CR treatment ATO 0.15 mg/kg IV over 2 hours Monday-Friday for 4 weeks, then 4-week break. Oral ATRA 45 mg/m2 every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.
|
|---|---|---|---|
|
Infections and infestations
Infection
|
8.8%
5/57 • Number of events 5 • Up to 7 years
|
0.00%
0/5 • Up to 7 years
|
6.2%
1/16 • Number of events 1 • Up to 7 years
|
Additional Information
Dr. Farhad Ravandi-Kashani, Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Phone: 7137927734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place