Trial Outcomes & Findings for Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia (NCT NCT01991457)

NCT ID: NCT01991457

Last Updated: 2024-01-12

Results Overview

Percentage of patients without relapse of disease at 2 years

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 2 years post-transplant
• Results posted on: 2024-01-12

Participant Flow

Participant milestones

Measure	Treatment Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	19 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years post-transplant

Percentage of patients without relapse of disease at 2 years

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Percentage of Subjects Disease-free Survival	63.2 percentage of participants

SECONDARY outcome

Timeframe: 2 years post-transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Percentage of Subjects That Survived	68.4 Percentage of subjects that survived

SECONDARY outcome

Timeframe: Within the first 100 days

Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) > 500/μL. Measuring the number of days it takes for (ANC) > 500/μL.

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Time to Neutrophil Engraftment	12 days Interval 10.0 to 24.0

SECONDARY outcome

Timeframe: Within first 100 days post-transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Number of Subjects With Regimen Related Toxicity Acute kidney injury*	4 participants
Number of Subjects With Regimen Related Toxicity Gastrointestinal (GI	4 participants
Number of Subjects With Regimen Related Toxicity Mucositis	3 participants

SECONDARY outcome

Timeframe: 2 years post transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Percentage of Subjects With Acute GVHD	26.1 percentage of aGVHD

SECONDARY outcome

Timeframe: 1 year post transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Number of Patients With Immune Reconstitution	19 Participants

SECONDARY outcome

Timeframe: 2 Years post-transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Percentage of Subjects With Relapse	7.1 percentage of subjects with relapse

SECONDARY outcome

Timeframe: Within 100 days post transplant

Platelet engraftment is defined as the first of 3 consecutive days with a platelet count > 20,000/μL without platelet transfusion for 7 days.

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Number of Subjects With Platelet Engraftment	19 Number of subjects with platelet engraft

SECONDARY outcome

Timeframe: 2 years post transplant

Outcome measures

Measure	Treatment n=19 Participants Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Percentage of Subjects With Chronic GVHD	32 Percentage of subjects with chronic GVHD

Adverse Events

Treatment

Serious events: 11 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Measure	Treatment n=19 participants at risk Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Renal and urinary disorders Acute kidney injury	21.1% 4/19 • 100 days
Gastrointestinal disorders Gastrointestinal (GI)	21.1% 4/19 • 100 days
Gastrointestinal disorders Mucositis	15.8% 3/19 • 100 days

Other adverse events

Measure	Treatment n=19 participants at risk Fludarabine, Total Body Irradiation (TBI) Fludarabine Total Body Irradiation
Cardiac disorders Atrial flutter	5.3% 1/19 • 100 days
Nervous system disorders Encephalopathy	5.3% 1/19 • 100 days
Renal and urinary disorders Hyponatremia	5.3% 1/19 • 100 days
Hepatobiliary disorders Elevated liver enzymes	5.3% 1/19 • 100 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 1/19 • 100 days

Additional Information

Dr. Omer Jamy

University of Alabama at Birmingham

Phone: 2059349294

Email: omerjamy@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place