A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
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| ClinicalTrials.gov Identifier: NCT01483690 |
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Recruitment Status :
Terminated
(Toxicity)
First Posted : December 1, 2011
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
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Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Acute Lymphoblastic Leukemia Precursor B-Cell Lymphoblastic Leukemia Precursor T-Cell Lymphoblastic Leukemia |
| Interventions |
Drug: Decitabine Drug: Vorinostat Drug: Vincristine Drug: Dexamethasone Drug: Mitoxantrone Drug: Pegaspargase Drug: Methotrexate |
| Enrollment | 23 |
Participant Flow
| Recruitment Details | This is a pilot study where 16 patients are anticipated to be enrolled. Anticipated enrollment will take 2.5 years. |
| Pre-assignment Details |
| Arm/Group Title | Initial Dose Level | Modified Dose Level |
|---|---|---|
 Arm/Group Description |
Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24 |
Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21 |
| Period Title: Overall Study | ||
| Started | 5 | 18 |
| Completed | 3 | 13 |
| Not Completed | 2 | 5 |
| Reason Not Completed | ||
| Adverse Event | 1 | 2 |
| clinical deterioration | 1 | 0 |
| Physician Decision | 0 | 2 |
| exclusionary procedure | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Initial Dose Level | Modified Dose Level | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24 |
Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21 |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 5 | 18 | 23 | |
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Baseline Analysis Population Description |
Total number of participants enrolled into the study.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 5 participants | 18 participants | 23 participants | |
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12.5
(4.9 to 14.5)
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12.0
(1.6 to 21.4)
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12.0
(1.6 to 21.4)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 18 participants | 23 participants | |
| Female |
2 40.0%
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4 22.2%
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6 26.1%
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| Male |
3 60.0%
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14 77.8%
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17 73.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 18 participants | 23 participants | |
| Hispanic or Latino |
3 60.0%
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9 50.0%
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12 52.2%
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| Not Hispanic or Latino |
2 40.0%
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9 50.0%
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11 47.8%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | 18 participants | 23 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
0 0.0%
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1 5.6%
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1 4.3%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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2 11.1%
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2 8.7%
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| White |
5 100.0%
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10 55.6%
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15 65.2%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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5 27.8%
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5 21.7%
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CNS Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 5 participants | 18 participants | 23 participants |
| CNS 1 |
4 80.0%
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14 77.8%
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18 78.3%
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| CNS 2 |
1 20.0%
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2 11.1%
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3 13.0%
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| CNS 3 |
0 0.0%
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2 11.1%
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2 8.7%
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[1]
Measure Description:
Central nervous system (CNS) disease is divided into the following: CNS 1 - no evidence of leukemia cerebral spinal fluid (CSF)(best outcome) CNS 2 - <5 WBC in CSF with blasts present CNS 3 - > or = 5 WBC in CSF with blasts present (worse outcome). |
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Prior hematopoietic cell transplantation (HCT)
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 5 participants | 18 participants | 23 participants |
| Yes had prior HCT |
3 60.0%
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8 44.4%
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11 47.8%
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| No did not have prior HCT |
2 40.0%
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10 55.6%
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12 52.2%
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Relapse # at enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 5 participants | 18 participants | 23 participants |
| 2nd Relapse |
2 40.0%
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13 72.2%
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15 65.2%
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| 3rd Relapse |
1 20.0%
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1 5.6%
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2 8.7%
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| Refractory |
2 40.0%
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4 22.2%
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6 26.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Clinical Research Coordinator, Consortia |
| Organization: | Therapeutic Advancements of Childhood Leukemia and Lymphoma |
| Phone: | 323-361-5312 |
| EMail: | rleong@chla.usc.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Advances in Childhood Leukemia Consortium |
| ClinicalTrials.gov Identifier: | NCT01483690 |
| Other Study ID Numbers: |
T2009-003 |
| First Submitted: | November 29, 2011 |
| First Posted: | December 1, 2011 |
| Results First Submitted: | September 8, 2020 |
| Results First Posted: | October 27, 2020 |
| Last Update Posted: | October 27, 2020 |