Trial Outcomes & Findings for Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies (NCT NCT01839916)

NCT ID: NCT01839916

Last Updated: 2019-08-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2019-08-07

Participant Flow

Participant milestones

Measure	Treatment (DLI) Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	77
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Measure	Treatment (DLI) Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Overall Study Death	9
Overall Study Physician Decision	17
Overall Study Relapse	12
Overall Study GVHD	2
Overall Study Graft Failure	1

Baseline Characteristics

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Baseline characteristics by cohort

Measure	Treatment (DLI) n=77 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	3 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Measure	Treatment (DLI) n=77 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment	36 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Patients received at least one DLI Treatment.

Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.

Outcome measures

Measure	Treatment (DLI) n=36 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Progression Free Survival (PFS)	43 percentage of patients Interval 29.0 to 63.9

SECONDARY outcome

Timeframe: At 2 years

Population: Patients received at least one DLI Treatment.

Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.

Outcome measures

Measure	Treatment (DLI) n=36 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival (OS)	59.7 percentage of patients Interval 44.8 to 79.4

SECONDARY outcome

Timeframe: At 1 year and 2 year

Population: Patients received at least one DLI Treatment.

Estimated by cumulative incidence method.

Outcome measures

Measure	Treatment (DLI) n=36 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Rate of Acute GVHD (aGVHD) With Any Grade At 2 year	41.8 percentage of patients Interval 24.6 to 58.1
Rate of Acute GVHD (aGVHD) With Any Grade At 1 year	41.8 percentage of patients Interval 24.6 to 58.1

SECONDARY outcome

Timeframe: At 1 year and 2 year

Population: Patients received at least one DLI treatment.

Estimated by cumulative incidence method.

Outcome measures

Measure	Treatment (DLI) n=36 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Rate of Chronic GVHD (cGVHD) At 1 year	26.6 percentage of patients Interval 12.2 to 43.4
Rate of Chronic GVHD (cGVHD) At 2 year	26.6 percentage of patients Interval 12.2 to 43.4

SECONDARY outcome

Timeframe: At 2 year

Population: Patients received at least one DLI treatment.

Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.

Outcome measures

Measure	Treatment (DLI) n=36 Participants Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Treatment-related Mortality	12.1 percentage of patients Interval 3.7 to 25.9

Adverse Events

Treatment (DLI)

Serious events: 12 serious events

Other events: 1 other events

Deaths: 17 deaths

Serious adverse events

Measure	Treatment (DLI) n=36 participants at risk Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.8% 1/36 • 2 year
General disorders Death	5.6% 2/36 • 2 year
Gastrointestinal disorders Diarrhea from drug	2.8% 1/36 • 2 year
Nervous system disorders Dizziness	2.8% 1/36 • 2 year
General disorders Fever	5.6% 2/36 • 2 year
Skin and subcutaneous tissue disorders Rash	2.8% 1/36 • 2 year
Nervous system disorders nervous system disorder	2.8% 1/36 • 2 year
Reproductive system and breast disorders Pneumonia	2.8% 1/36 • 2 year
Injury, poisoning and procedural complications Burn	2.8% 1/36 • 2 year
Renal and urinary disorders Acute Kindey Injury	2.8% 1/36 • 2 year
Renal and urinary disorders Small Bowel obstruction	2.8% 1/36 • 2 year
Vascular disorders Hypotension	2.8% 1/36 • 2 year
Immune system disorders Disseminated zoster	2.8% 1/36 • 2 year
Infections and infestations Infection	2.8% 1/36 • 2 year
Injury, poisoning and procedural complications leg fracture due to fall	2.8% 1/36 • 2 year
Investigations Liver GVHD	5.6% 2/36 • 2 year
Gastrointestinal disorders Viral diarrhea	2.8% 1/36 • 2 year

Other adverse events

Measure	Treatment (DLI) n=36 participants at risk Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
Infections and infestations Sepsis	2.8% 1/36 • 2 year

Additional Information

Dr. Hongtao Liu

University of Chicago

Phone: 773-834-1736

Email: hliu2@medicine.bsd.uchicago.edu

Results disclosure agreements

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