Trial Outcomes & Findings for Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia (NCT NCT01158885)

Last Updated: 2021-10-26

Results Overview

To be assessed in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on courses 1 and 2.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Sample collected between Days 22-36 of courses 1 and 2

Results posted on

2021-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Clofarabine, Cytarabine, Methotrexate See detailed description in Interventions section.
Treatment Course 1 STARTED	2
Treatment Course 1 COMPLETED	2
Treatment Course 1 NOT COMPLETED	0
Treatment Course 2 STARTED	0
Treatment Course 2 COMPLETED	0
Treatment Course 2 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=2 Participants Clofarabine, Cytarabine, Methotrexate See detailed description in Interventions section.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Sample collected between Days 22-36 of courses 1 and 2

Population: Study was closed prematurely and none of the patients treated were eligible for analysis of disease response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Beginning with the first dose of investigational product until day 56 of treatment course, an average of 1 year

Population: All patients treated on Treatment Course 1.

Treatment related toxicities that preclude proceeding to HSCT by day 56 of the treatment course.

Outcome measures

Outcome measures
Measure	Single Arm n=2 Participants Clofarabine, Cytarabine, Methotrexate See detailed description in Interventions section.
Number of Patients With Dose-Limiting Toxicity (DLT)	0 Participants

SECONDARY outcome

Timeframe: Every 3 months for life following completion of protocol therapy.

Population: None of the patients treated on Treatment Course 1 proceeded to HCT. 1 patient upon completion of Treatment Course 1 proceeded with Bone Marrow Transplant and 1 patient was removed early from protocol treatment during Course 1 due to progressive disease.

After the patient completes therapy on this protocol, data will continue to be collected regarding whether the patient proceeded to HCT. Toxicity and adverse event information will be collected.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=2 participants at risk Clofarabine, Cytarabine, Methotrexate See detailed description in Interventions section.
Blood and lymphatic system disorders Febrile neutropenia	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Platelet count decreased	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Infections and infestations Grade 4 Infection	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	Single Arm n=2 participants at risk Clofarabine, Cytarabine, Methotrexate See detailed description in Interventions section.
Investigations Alanine aminotransferase	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Febrile neutropenia	50.0% 1/2 • Number of events 2 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Hemoglobin	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Leukopenia NOS	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Lymphopenia	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Neutrophil count	50.0% 1/2 • Number of events 1 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Platelet count decreased	50.0% 1/2 • Number of events 2 • Approximately 2 years The definition of AE and SAE used to collect adverse event information does not differ from the clinicaltrials.gov definitions.

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