Trial Outcomes & Findings for T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) (NCT NCT04128319)

Last Updated: 2021-12-16

Results Overview

Complete Response at Day 28 is defined as a score of 0 for the GVHD staging in all evaluable organs at the Day 28 visit along with freedom from additional systemic therapy for treatment of acute GVHD.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

Day 28

Results posted on

2021-12-16

Participant Flow

Participants from 2 transplant centers willing to participate signed an Institutional Review Board approved Informed Consent Form and had eligibility for enrollment evaluated. If a participant's eligibility was confirmed they were enrolled into the study. The first participant was enrolled in December 2019, and the last participant was enrolled in January 2020.

Participant milestones

Participant milestones
Measure	T-Guard Treatment Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Overall Study STARTED	3
Overall Study Initiated T-Guard Treatment	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	T-Guard Treatment Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Overall Study Death	3

Baseline Characteristics

T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T-Guard Treatment n=3 Participants Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Age, Continuous	36.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 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	1 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

PRIMARY outcome

Timeframe: Day 28

Outcome measures

Outcome measures
Measure	T-Guard Treatment n=3 Participants Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Complete Response (CR)	0 Participants

SECONDARY outcome

Timeframe: Through Day 180

Population: Study stopped as safety stopping guideline was met.

Evaluate the duration of complete response (DoCR) Early Trial Closure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 30

Estimate the overall survival (OS) at Day 30.

Outcome measures

Outcome measures
Measure	T-Guard Treatment n=3 Participants Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Overall Survival (OS)	3 Participants

SECONDARY outcome

Timeframe: Days 14, 28, and 56

Population: Study stopped as safety stopping guideline was met.

Estimate the overall response rate (CR or partial response (PR)) at Days 14, 28, and 56.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 7, 14, 28, and 56

Population: Study stopped as safety stopping guideline was met.

Describe proportions of CR, PR, mixed response (MR), no response (NR), and progression of aGVHD at Days 7, 14, 28, and 56.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 100 and 180

Population: Study stopped as safety stopping guideline was met.

Estimate the cumulative incidence of non-relapse mortality (NRM) at Days 100 and 180.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 180

Population: Study stopped as safety stopping guideline was met.

Estimate relapse-free survival at Day 180.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 90 and 180

Population: Study stopped as safety stopping guideline was met.

Estimate GVHD-free survival at Days 90 and 180

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

Population: Study stopped as safety stopping guideline was met.

Estimate the cumulative incidence of chronic GVHD (cGVHD) at Day 180

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

Population: Study stopped as safety stopping guideline was met.

Estimate the cumulative incidence of disease relapse/progression at Day 180

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: initiation of T-Guard to 28 days post-last dose

Population: Study stopped as safety stopping guideline was met.

Describe the incidence of systemic infections

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: initiation of T-Guard to 28 days post-last dose

Population: Study stopped as safety stopping guideline was met.

Describe the incidence of CTCAE v5 Grade 3-5 toxicities

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before each infusion & at the following post-infusion timepoints: 4, 5, 6, 8 & 24 hours for the 1st infusion; 4, 6 & 24 hours for the 2nd & 3rd infusions; 4, 6, 24 & 48 hours for the 4th infusion (infusions occur within the time frame of Day 0 to Day 14)

Population: Study stopped as safety stopping guideline was met.

Observed and model-predicted concentration of T-Guard at the end of infusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Study stopped as safety stopping guideline was met.

Systemic clearance of T-Guard

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Study stopped as safety stopping guideline was met.

Model-predicted area under the curve from the start of the current infusion until the next infusion or until 48 hours following for the last infusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Study stopped as safety stopping guideline was met.

Model-predicted terminal half-life of T-Guard

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Study stopped as safety stopping guideline was met.

Volume of the central compartment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28, 90, and 180

Population: Study stopped as safety stopping guideline was met.

Assess the immunogenicity of T-Guard via ADA responses in the form of human anti-SPV-T3a-RTA and anti-WT1-RTA -antibodies evaluated in serum samples

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Days 28 and 56

Population: Study stopped as safety stopping guideline was met.

Corticosteroid-dose (measured in prednisone-equivalent) at baseline, Days 28 and 56 post initiation of T- Guard therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 28 and 56

Population: Study stopped as safety stopping guideline was met.

Estimate the rate of near-CR (i.e. CR in GI and Liver with only Stage 1 Skin) at Days 28 and 56 post initiation of T- Guard therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 180

Population: Study stopped as safety stopping guideline was met.

Describe discontinuation of systemic steroids by Day 180 post initiation of T-Guard therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 180

Population: Study stopped as safety stopping guideline was met.

Estimate the incidence of CMV reactivation requiring therapy by Day 180 post initiation of T-Guard Therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 180

Population: Study stopped as safety stopping guideline was met.

Estimate the incidence of Epstein-Barr Virus (EBV)- associate lymphoproliferative disorder or EBV reactivation requiring therapy with rituximab by Day 180 post initiation of T-Guard therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through Day 180

Population: Study stopped as safety stopping guideline was met.

Describe the incidence of Investigational Medicinal Product (IMP) related SAEs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Days 0, 2, 4, 6, 14, 28, 56, 180

Population: Study stopped as safety stopping guideline was met.

The evolution of specific cell populations over the 180 day follow-up period and, in particular, T-Guard's effect in depleting targeted T cell and NK cell subsets as well as its impact on relevant non-target populations (B cells, monocytes and dendritic cells), will be evaluated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Days 7, 14, 28

Population: Study stopped as safety stopping guideline was met.

Serum ST2 and Regenerating Family Member 3 Alpha (REG3α) concentrations and urine 3- Indoxyl Sulfate (3-IS) concentrations will be used to estimate the probability of NRM at Day 180 post-assessment for each patient. The proportion of patients with high risk biomarker status (defined as estimated NRM greater than 0.29) will be described at each time point.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Days 28, 56, 180

Population: Study stopped as safety stopping guideline was met.

Describe changes in patient-reported outcomes (PROs) using a subset of the PROMIS measures from baseline to Days 28, 56, and 180 post initiation of T- Guard therapy

Outcome measures

Outcome data not reported

Adverse Events

T-Guard Treatment

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	T-Guard Treatment n=3 participants at risk Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Blood and lymphatic system disorders Thrombotic microangiopathy	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Cardiac disorders Cardiac arrest after septic shock	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Infections and infestations Aspergillus pulmonary infection	100.0% 3/3 • Number of events 4 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Infections and infestations Metapneumovirus infection	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Infections and infestations Staphylococcal sepsis	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Myositis	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	T-Guard Treatment n=3 participants at risk Patients will receive T-Guard for treatment of steroid-refractory acute GVHD. T-Guard: Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m\^2 Body Surface Area (BSA).
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Duodenal ulcer	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Gastrointestinal inflammation	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Ileus	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Large intestinal ulcer	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Mouth ulceration	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Gastrointestinal haemorrhage	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Gastrointestinal disorders Odynophagia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
General disorders Pyrexia	33.3% 1/3 • Number of events 2 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Investigations Differential white blood cell count abnormal	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Investigations Transaminases increased	66.7% 2/3 • Number of events 2 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Acidosis	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypernatraemia	66.7% 2/3 • Number of events 2 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypophagia	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Malnutrition	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Myopathy	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Nervous system disorders Encephalopathy	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Psychiatric disorders Confusional state	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Sinus congestion	33.3% 1/3 • Number of events 1 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Vascular disorders Hypotension	66.7% 2/3 • Number of events 2 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.
Vascular disorders Septic Shock	33.3% 1/3 • Number of events 2 • The study has recruited only 3 SR-aGVHD patients who were treated with T-Guard therapy (2 received the full four doses and 1 received only three doses) during a short period of 69 days. The adverse event collection followed the clinicaltrials.gov definitions.

Additional Information

Eric van Hooren, Chief Development Officer

Xenikos

Phone: +31 6 109 345 84

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators agree to the disclosure requirements in a Protocol Rider. This states that the BMT CTN DCC will lead on the initial study Publication, and for any subsequent study Publication, with either a) the advance review of Sponsor or b) two years after the completion of the Study at all Study Sites, the DCC, Participating Sites, and Principal Investigators may publicly disclose or submit for Publication an article, poster or other material that includes analysis of the study results.
Publication restrictions are in place

Restriction type: OTHER