Trial Outcomes & Findings for ABT-751 With Chemotherapy for Relapsed Pediatric ALL (NCT NCT00439296)

Last Updated: 2021-03-17

Results Overview

ABT-751 was given daily for 21 days for a period of 28 day course in combination with dexamethasone, PEG-asparaginase, and doxorubicin. The occurrence of a dose limiting toxicity (DLT) was evaluated at the end of the 28 day course. DLT will be defined as any of the following events that are deemed by the investigator as probably or definitely attributable to ABT-751. Toxicity grade follows the CTCAE criteria, version 3.0. A copy of the CTCAE can be downloaded from the CTEP home page (http://ctep.cancer.gov). * Grade 3 or 4 Ileus * Grade 3 or 4 Constipation * Grade 3 or 4 Gastrointestinal obstruction, any location * Grade 3 or 4 Sensory Neuropathy * Grade 3 or 4 Motor Neuropathy * Grade 3 or 4 Neuropathic pain lasting longer than 24 hours despite medical intervention * Grade 3 or 4 Hypoxia in the absence of anemia or infection * Grade 4 Alanine aminotransferase (ALT) which does not return to

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Each dose level is evaluated

Results posted on

2021-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
Overall Study STARTED	5	4
Overall Study Treatment Course 1	5	3
Overall Study Treatment Course 2	1	1
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=5 Participants Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 n=4 Participants De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each dose level is evaluated

Population: Number of participants that completed at least 1 course of treatment and are evaluable for toxicities.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 n=4 Participants De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
Number of Patients That Experienced Dose Limiting Toxicity From ABT-751 # of patients with DLT	2 Participants	0 Participants
Number of Patients That Experienced Dose Limiting Toxicity From ABT-751 # of patients without DLT	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 29 of Course 1

Population: Number of patients that completed at least 1 course of treatment and was evaluable for response assessment.

Complete response (CR) is the occurrence of all of the following on approximately Day 29: less than 5% leukemic blasts in the bone marrow aspirate with no evidence of leukemic blasts in the CSF or peripheral blood and recovery of peripheral blood counts of an Absolute neutrophil count (ANC) \> 750/μL and Platelet count \> 75,000 μL.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 n=4 Participants De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
Number of Patients That Achieved Complete Response to ABT-751 # of patients not achieving complete response	4 Participants	1 Participants
Number of Patients That Achieved Complete Response to ABT-751 # of patients who achieved complete response	1 Participants	3 Participants

SECONDARY outcome

Timeframe: From the first dose of study therapy until 30 days after last therapy dose. Last dose protocol therapy is on day 21.

Population: Number of patients that completed at least 1 course of treatment.

The occurrence of toxic death at anytime that is definitely, probably or possibly related to the treatment.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 n=4 Participants De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
Number of Patients With Occurrence of Toxic Death # of patients that experienced toxic death	0 Participants	0 Participants
Number of Patients With Occurrence of Toxic Death # of patients that did not experience toxic death	5 Participants	4 Participants

Adverse Events

Dose Level 1

Serious events: 5 serious events

Other events: 5 other events

Deaths: 4 deaths

Dose Level 0

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 n=5 participants at risk Starting dose for study is 80 mg/m2/day of ABT-751	Dose Level 0 n=4 participants at risk De-escalation dose due to DLTs: 65 mg/m2/day of ABT-751
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	25.0% 1/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Gastrointestinal disorders Dehydration	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Gastrointestinal disorders Diarrhea NOS	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	75.0% 3/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Metabolism and nutrition disorders Hyperglycemia NOS	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Gastrointestinal disorders Ileus paralytic	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Infections and infestations Infection w/ Gr 3/4 ANC, Blood	80.0% 4/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	25.0% 1/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Infections and infestations Infection w/ Gr 3/4 ANC, Nose	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	0.00% 0/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions
Infections and infestations Infection w/ Gr 3/4 ANC, Skin	20.0% 1/5 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions	25.0% 1/4 • Adverse events and serious adverse events will be collected and reported on the electronic case report forms beginning with the first dose of investigational product until 30 days following the last dose of ABT-751, whether elicited or spontaneously reported by the patient, up to day 51 days (30 days after day 21, last day of the protocol therapy). The definition of adverse event (AE) and serious adverse event (SAE) do not differ from the clinicaltrials.gov definitions

Other adverse events

Additional Information

Peggy Romano, BA, CCRP

Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles

Phone: 323-361-5505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60