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Trial record 2 of 10 for:    "Acute T Cell Leukemia" | "Etoposide"

Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

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ClinicalTrials.gov Identifier: NCT02518750
Recruitment Status : Terminated (Due to slow accrual)
First Posted : August 10, 2015
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Lymphoblastic Leukemia
Lymphoma, Non-Hodgkin's
Leukemia, T-Cell
Leukemia, B-Cell
Interventions Drug: Dexamethasone
Drug: Panobinostat
Drug: Liposomal vincristine
Drug: Mitoxantrone
Drug: Peg-asparaginase
Drug: Bortezomib
Drug: Intrathecal Triples
Drug: High-dose methotrexate
Drug: 6-Mercaptopurine
Drug: High-dose cytarabine
Drug: Nelarabine
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Clofarabine
Enrollment 3
Recruitment Details 3 patients were recruited between Nov. 2016 and Jan. 2018
Pre-assignment Details  
Arm/Group Title Study Paticipants
Hide Arm/Group Description

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Arm/Group Title Study Participants
Hide Arm/Group Description

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
3
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title Complete Remission (CR) Rate
Hide Description All participants who start re-induction Block A therapy are considered evaluable. Any patient who at any time point achieves CR and goes to transplant is considered as a success; or any patient who successfully reaches the end of block C and achieves/remains in CR is considered a success; all other cases are considered as failure.
Time Frame At the end of each remission re-induction block C (approximately 13 weeks after start of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Given the very small enrollment number, no statistical analyses was performed.
Arm/Group Title Study Paticipants
Hide Arm/Group Description:

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Block A Minimal Residual Disease (MRD)
Hide Description MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.
Time Frame At the end of Block A therapy (approximately 5 weeks after start of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Given the very small enrollment number, no statistical analyses was performed.
Arm/Group Title Study Paticipants
Hide Arm/Group Description:

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Block B Minimal Residual Disease (MRD)
Hide Description MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.
Time Frame At the end of Block B therapy (approximately 10 weeks after start of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
No participant received Block B therapy.
Arm/Group Title Study Paticipants
Hide Arm/Group Description:

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Block C Minimal Residual Disease (MRD)
Hide Description MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.
Time Frame At the end of Block C therapy (approximately 13 weeks after start of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
No participant received Block C therapy.
Arm/Group Title Study Paticipants
Hide Arm/Group Description:

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Proportion of Relevant Toxicities
Hide Description The toxicities of liposomal vincristine (VSLI) when used in combination with chemotherapy will be evaluated. Proportions (probabilities) of relevant toxicities will be estimated with point and interval estimates.
Time Frame At the completion of therapy (up to approximately 5 months after the start of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
Given the very small enrollment number, no statistical analyses was performed.
Arm/Group Title Study Paticipants
Hide Arm/Group Description:

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine.
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Participants
Hide Arm/Group Description

Participants with ALL will receive the following interventions in three treatment blocks:

  • Block A: Dexamethasone, panobinostat, liposomal vincristine, mitoxantrone, peg-asparaginase, bortezomib, intrathecal triples
  • Block B: High-dose methotrexate, 6-mercaptopurine, intrathecal triples, high-dose cytarabine
  • Block C: Nelarabine or clofarabine, cyclophosphamide, etoposide
All-Cause Mortality
Study Participants
Affected / at Risk (%)
Total   3/3 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Study Participants
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Infections and infestations   
Sepsis * 1  2/3 (66.67%)  2
1
Term from vocabulary, CTCAE v4.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Participants
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Gastrointestinal disorders   
Diarrhea * 1  1/3 (33.33%)  1
Nausea * 1  1/3 (33.33%)  1
Infections and infestations   
Sepsis * 1  2/3 (66.67%)  2
Encephalitis infection * 1  1/3 (33.33%)  1
Enterocolitis infectious * 1  1/3 (33.33%)  1
Lung infection * 1  1/3 (33.33%)  1
Investigations   
Alanine aminotransferase increased * 1  1/3 (33.33%)  1
Blood bilirubin increased * 1  1/3 (33.33%)  1
GGT increased * 1 [1]  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Hypokalemia * 1  2/3 (66.67%)  9
Hypernatremia * 1  1/3 (33.33%)  5
Hyperglycemia * 1  2/3 (66.67%)  4
Hypocalcemia * 1  2/3 (66.67%)  3
Hypophosphatemia * 1  1/3 (33.33%)  3
Hypoalbuminemia * 1  1/3 (33.33%)  2
Anorexia * 1  1/3 (33.33%)  1
Nervous system disorders   
Headache * 1  1/3 (33.33%)  3
Vascular disorders   
Hypertension * 1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE v4.0
*
Indicates events were collected by non-systematic assessment
[1]
Gamma-glutamyltransferase
Given the very small enrollment number, no statistical analyses was performed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sima Jeha, MD
Organization: St. Jude Children's Research Hospital
Phone: 901-595-3901
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02518750     History of Changes
Other Study ID Numbers: TSALV
NCI-2015-00935 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Submitted: July 16, 2015
First Posted: August 10, 2015
Results First Submitted: March 8, 2019
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019