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Trial Outcomes & Findings for 2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II (NCT NCT03941769)

NCT ID: NCT03941769

Last Updated: 2024-10-17

Results Overview

Participants that had grade 3 or 4 graft versus host disease (GVHD), secondary graft failure, disease relapse, development of post-transplant lymphoproliferative disorder, development of progressive multifocal leukoencephalopathy or grade 3-4 organ failure attributable to recombinant human interleukin-7 (CYT107) and death.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 42 days after first injection

Results posted on

2024-10-17

Participant Flow

Recruitment was done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure
Supportive Care (Recombinant Interleukin-7)
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks. Recombinant Interleukin-7: Given IM or SC
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Supportive Care (Recombinant Interleukin-7)
n=1 Participants
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks. Recombinant Interleukin-7: Given IM or SC
Age, Categorical
<=18 years
0 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
1 Participants
n=5 Participants
Sex: Female, Male
Male
0 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
1 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
Region of Enrollment
United States
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 42 days after first injection

Participants that had grade 3 or 4 graft versus host disease (GVHD), secondary graft failure, disease relapse, development of post-transplant lymphoproliferative disorder, development of progressive multifocal leukoencephalopathy or grade 3-4 organ failure attributable to recombinant human interleukin-7 (CYT107) and death.

Outcome measures

Outcome measures
Measure
Supportive Care (Recombinant Interleukin-7)
n=1 Participants
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks. Recombinant Interleukin-7: Given IM or SC
Number of Participants With Dose Limiting Toxicities
0 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Number of participant that survived after 3 years.

Outcome measures

Outcome measures
Measure
Supportive Care (Recombinant Interleukin-7)
n=1 Participants
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks. Recombinant Interleukin-7: Given IM or SC
Overall Survival
0 Participants

Adverse Events

Supportive Care (Recombinant Interleukin-7)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Supportive Care (Recombinant Interleukin-7)
n=1 participants at risk
Within 60-180 days after CBT, patients receive recombinant interleukin-7 IM or SC once per week for 3 weeks. Recombinant Interleukin-7: Given IM or SC
Investigations
White blood cell decreased
100.0%
1/1 • 42 days from the last injection of CYT107, up to 3 years
General disorders
Increased ALT
100.0%
1/1 • 42 days from the last injection of CYT107, up to 3 years
Infections and infestations
Urinary Tract Infection
100.0%
1/1 • 42 days from the last injection of CYT107, up to 3 years
Injury, poisoning and procedural complications
Fall
100.0%
1/1 • 42 days from the last injection of CYT107, up to 3 years
Infections and infestations
ANC Decreased
100.0%
1/1 • 42 days from the last injection of CYT107, up to 3 years

Additional Information

Gheath Al-Atrash, M.D. / Stem Cell Transplantation

The University of Texas MD Anderson Cancer Center

Phone: 713-792-7734

Results disclosure agreements

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