Trial Outcomes & Findings for Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma (NCT NCT02518750)
NCT ID: NCT02518750
Last Updated: 2019-04-03
Results Overview
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.
TERMINATED
PHASE2
3 participants
At the end of each remission re-induction block C (approximately 13 weeks after start of therapy)
2019-04-03
Participant Flow
3 patients were recruited between Nov. 2016 and Jan. 2018
Participant milestones
| Measure |
Study Paticipants
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
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|---|---|
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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1
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|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Baseline characteristics by cohort
| Measure |
Study Participants
n=3 Participants
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
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|---|---|
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Age, Categorical
<=18 years
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3 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At the end of each remission re-induction block C (approximately 13 weeks after start of therapy)Population: Given the very small enrollment number, no statistical analyses was performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of Block A therapy (approximately 5 weeks after start of therapy)Population: Given the very small enrollment number, no statistical analyses was performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of Block B therapy (approximately 10 weeks after start of therapy)Population: No participant received Block B therapy.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of Block C therapy (approximately 13 weeks after start of therapy)Population: No participant received Block C therapy.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the completion of therapy (up to approximately 5 months after the start of therapy)Population: Given the very small enrollment number, no statistical analyses was performed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Study Participants
Serious adverse events
| Measure |
Study Participants
n=3 participants at risk
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
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|---|---|
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Infections and infestations
Sepsis
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66.7%
2/3 • Number of events 2 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Other adverse events
| Measure |
Study Participants
n=3 participants at risk
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
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|---|---|
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Metabolism and nutrition disorders
Hypokalemia
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66.7%
2/3 • Number of events 9 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Metabolism and nutrition disorders
Hypernatremia
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33.3%
1/3 • Number of events 5 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Metabolism and nutrition disorders
Hyperglycemia
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66.7%
2/3 • Number of events 4 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Metabolism and nutrition disorders
Hypocalcemia
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66.7%
2/3 • Number of events 3 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Metabolism and nutrition disorders
Hypophosphatemia
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33.3%
1/3 • Number of events 3 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Nervous system disorders
Headache
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33.3%
1/3 • Number of events 3 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Infections and infestations
Sepsis
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66.7%
2/3 • Number of events 2 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
|
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Metabolism and nutrition disorders
Hypoalbuminemia
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33.3%
1/3 • Number of events 2 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
|
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Gastrointestinal disorders
Diarrhea
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Gastrointestinal disorders
Nausea
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Infections and infestations
Encephalitis infection
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Infections and infestations
Enterocolitis infectious
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Infections and infestations
Lung infection
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Investigations
Alanine aminotransferase increased
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Investigations
Blood bilirubin increased
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Investigations
GGT increased
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Metabolism and nutrition disorders
Anorexia
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Vascular disorders
Hypertension
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33.3%
1/3 • Number of events 1 • Adverse events were collected until either the participant died or up to 30 days after protocol treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place