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Trial record 39 of 49 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Pegaspargase"

Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00882206
Recruitment Status : Terminated (Slow accrual)
First Posted : April 16, 2009
Results First Posted : October 28, 2016
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Drug: cytarabine
Drug: decitabine
Drug: doxorubicin hydrochloride
Drug: imatinib mesylate
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: vincristine sulfate
Drug: vorinostat
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description

This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.

cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.

*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.

decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour

doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes

imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.

methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.

pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)

prednisone: 40mg/m2/day divided BID (days 5 – 33)

vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
16
(3 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Response to Treatment
Hide Description Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)
Time Frame Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description:
This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title Level of Methylation
Hide Description the percentage of methylated DNA
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description:

This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.

cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.

*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.

decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour

doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes

imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.

methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.

pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)

prednisone: 40mg/m2/day divided BID (days 5 – 33)

vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of DNA
84.98  (1.48)
3.Secondary Outcome
Title Level of Methylation
Hide Description the percentage of methylated DNA
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description:

This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.

cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.

*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.

decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour

doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes

imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.

methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.

pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)

prednisone: 40mg/m2/day divided BID (days 5 – 33)

vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of DNA
79.82  (3.04)
4.Secondary Outcome
Title Level of Methylation
Hide Description the percentage of methylated DNA
Time Frame Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description:

This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.

cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.

*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.

decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour

doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes

imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.

methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.

pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)

prednisone: 40mg/m2/day divided BID (days 5 – 33)

vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage of DNA
86.1  (1.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine / Vorinostat
Hide Arm/Group Description

This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.

cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.

*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.

decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour

doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes

imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.

methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.

pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)

prednisone: 40mg/m2/day divided BID (days 5 – 33)

vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)

All-Cause Mortality
Decitabine / Vorinostat
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Decitabine / Vorinostat
Affected / at Risk (%)
Total   8/13 (61.54%) 
Blood and lymphatic system disorders   
Febrile neutropenia   2/13 (15.38%) 
Gastrointestinal disorders   
Pancreatitis   2/13 (15.38%) 
Pain, abdominal   1/13 (7.69%) 
Infections and infestations   
Infection, blood   6/13 (46.15%) 
Investigations   
Lipase elevated   1/13 (7.69%) 
Metabolism and nutrition disorders   
Hypertriglyceridemia   1/13 (7.69%) 
Hyponatremia   1/13 (7.69%) 
Hyperglycemia   1/13 (7.69%) 
Hypercholesteremia   1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Pain, generalized body   1/13 (7.69%) 
Nervous system disorders   
Cerebral hemorrhage   1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/13 (7.69%) 
Decreased respiratory rate   1/13 (7.69%) 
Hypoxia - acute respiratory distress   1/13 (7.69%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Decitabine / Vorinostat
Affected / at Risk (%)
Total   13/13 (100.00%) 
Blood and lymphatic system disorders   
Hemorrhage, bladder   1/13 (7.69%) 
Leukocytes decreased   3/13 (23.08%) 
Anemia   6/13 (46.15%) 
Platelets count decreased   3/13 (23.08%) 
Neutrophil count decreased   1/13 (7.69%) 
Lymphopenia   1/13 (7.69%) 
Platelets   2/13 (15.38%) 
Bone marrow cellularity   1/13 (7.69%) 
Febrile neutropenia   6/13 (46.15%) 
Leukocytes   2/13 (15.38%) 
Neutrophils   1/13 (7.69%) 
ANC   1/13 (7.69%) 
Cardiac disorders   
Tachycardia   2/13 (15.38%) 
Hypertension   2/13 (15.38%) 
Ventricular arrythmia   1/13 (7.69%) 
Systolic murmur   1/13 (7.69%) 
Sinus tachycardia   1/13 (7.69%) 
Hypotension   1/13 (7.69%) 
Endocrine disorders   
Adrenal insufficiency   1/13 (7.69%) 
Eye disorders   
Photophobia   1/13 (7.69%) 
Blurred vision   1/13 (7.69%) 
Gastrointestinal disorders   
Nausea   4/13 (30.77%) 
Constipation   5/13 (38.46%) 
Diarrhea   3/13 (23.08%) 
Vomiting   1/13 (7.69%) 
Pancreatitis   1/13 (7.69%) 
Fluid retention, ascites   1/13 (7.69%) 
Lower molar pain   1/13 (7.69%) 
Abdominal pain   6/13 (46.15%) 
Mucositis   4/13 (30.77%) 
General disorders   
Fatigue   4/13 (30.77%) 
Edema, lower extremity   2/13 (15.38%) 
Edema, upper extremity   1/13 (7.69%) 
Generalised body aches   1/13 (7.69%) 
Weakness   1/13 (7.69%) 
Fever   2/13 (15.38%) 
Infections and infestations   
Infection, meningitis   1/13 (7.69%) 
Fungal infection, lung   1/13 (7.69%) 
Infection, soft tissue   1/13 (7.69%) 
Infection, neutopenia   2/13 (15.38%) 
Infection, positive blood culture   1/13 (7.69%) 
Injury, poisoning and procedural complications   
Pain uncontrolled   1/13 (7.69%) 
Pain, epigastric   1/13 (7.69%) 
Pain, headache   1/13 (7.69%) 
Pain, pedal bilateral   1/13 (7.69%) 
Pain, leg bilateral   2/13 (15.38%) 
Pain, stomach   1/13 (7.69%) 
Pain, left chest   1/13 (7.69%) 
Pain, low back/leg   1/13 (7.69%) 
Lower lip swelling   1/13 (7.69%) 
Pain, NOS   1/13 (7.69%) 
Investigations   
Hyperbilirubinemia   4/13 (30.77%) 
Weight gain   1/13 (7.69%) 
Creatinine   1/13 (7.69%) 
Lipase elevated   1/13 (7.69%) 
Alkaline phosphatase increased   2/13 (15.38%) 
ALT increased   4/13 (30.77%) 
Creatinine increased   2/13 (15.38%) 
Fibrinogen increased   1/13 (7.69%) 
Amylase   1/13 (7.69%) 
Lipase   1/13 (7.69%) 
Hypomagnesemia   1/13 (7.69%) 
AST increased   1/13 (7.69%) 
AST   1/13 (7.69%) 
Metabolism and nutrition disorders   
Hypermagnesemia   2/13 (15.38%) 
Hyponatremia   2/13 (15.38%) 
Hyperglycemia   5/13 (38.46%) 
Hyperchloremia   1/13 (7.69%) 
Hypertriglyceridemia   1/13 (7.69%) 
Albumin   2/13 (15.38%) 
Calcium   2/13 (15.38%) 
Glucose   1/13 (7.69%) 
Hypokalemia   5/13 (38.46%) 
Hyperkalemia   1/13 (7.69%) 
Hypoalbuminemia   3/13 (23.08%) 
Dehydration   1/13 (7.69%) 
Anorexia   1/13 (7.69%) 
Uric acid increased   1/13 (7.69%) 
Calcium decreased   2/13 (15.38%) 
Hyperphosphatemia   2/13 (15.38%) 
Calcium increased   1/13 (7.69%) 
Obesity   1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Knee pain   1/13 (7.69%) 
Back pain   1/13 (7.69%) 
Hip pain   1/13 (7.69%) 
Nervous system disorders   
Somnolence   2/13 (15.38%) 
Headaches   2/13 (15.38%) 
Hemiparesis, right side   1/13 (7.69%) 
Neuropathy   4/13 (30.77%) 
Psychiatric disorders   
Mood alteration, NOS   1/13 (7.69%) 
Depression   2/13 (15.38%) 
Anxiety   3/13 (23.08%) 
Insomnia   1/13 (7.69%) 
Confusion   1/13 (7.69%) 
Renal and urinary disorders   
Chronic kidney disease   1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia   2/13 (15.38%) 
Sleep apnea   1/13 (7.69%) 
Pleural effusion   1/13 (7.69%) 
Pulmonary infiltrate   1/13 (7.69%) 
Dyspnea   3/13 (23.08%) 
Skin and subcutaneous tissue disorders   
Hand foot reaction   1/13 (7.69%) 
Demi Erythema   1/13 (7.69%) 
Alopecia   2/13 (15.38%) 
Ulceration, decubitus   1/13 (7.69%) 
Rash   1/13 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Burke, MD
Organization: University of Minnesota, Pediatric Hematology Dept.
Phone: 612.672.7422
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00882206     History of Changes
Other Study ID Numbers: 2008LS112
0810M50401 ( Other Identifier: IRB, University of Minnesota )
MT2008-29R ( Other Identifier: Blood and Marrow Transplantation Program )
First Submitted: April 15, 2009
First Posted: April 16, 2009
Results First Submitted: April 10, 2015
Results First Posted: October 28, 2016
Last Update Posted: December 28, 2017