Donor Lymphocyte Infusion After Alternative Donor Transplantation

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01027702
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 87
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI) given with methotrexate to hasten immune recovery without causing severe graft-versus-host disease (GVHD) in recipients who have had a T-cell depleted transplant.

Condition or Disease	Intervention/Treatment	Phase
Immunodeficiency	Biological: Infusion of donor lymphocytes	Phase 1/Phase 2

Detailed Description

Studies have shown that giving donor T cells after a mismatched T cell-depleted stem cell transplant can speed up recovery of T cells in the patient. This approach can cause severe graft versus host disease (GVHD). The purpose of this study is to determine whether giving a donor lymphocyte infusion (DLI) with methotrexate can accelerate immune recovery in recipients of T cell-depleted stem cell transplants. Thirty days after a T-cell depleted transplant, patients will be given a DLI. They will be monitored for immune recovery as measured by CD4 count and for GVHD toxicity.

Patients will be separated into six cohorts based on dose of DLI received: 3 x 10^{4, 4 x 10}4, 5 x 10^{4, 6 X 10}4, 8 x 10^{4, and 10 X10}4 cells/ kg of body weight. A minimum of 3 patients will be tested at each dose starting with the lowest dose. Dose escalation will continue until the dose associated with CD4 count >100 at Day +120 after transplant without significant GVHD is determined. All patients will receive thirteen doses of methotrexate after the DLI to prevent GVHD. Patients will be followed for 2 years for outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34+ Cell-Selected Transplant
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infusion of donor lymphocytes Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.	Biological: Infusion of donor lymphocytes; A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Immune Recovery Following Transplantation [120 days after transplant]

   Immune recovery was measured by CD4+ cells > 100/μL by Day 120 following transplantation

2. Incidence and Severity of GVHD [180 days after transplant]

   Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.

Secondary Outcome Measures

1. Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD) [1 year]

   Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have been treated on the LCH BMT 09-01 protocol

• Signed informed consent by patient or legal guardian

Exclusion Criteria:

• Active GVHD at the time when DLI are due

• History of acute GVHD > grade I prior to DLI

• Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)

• Uncontrolled bacterial or fungal infection

• O2 saturation by pulse oximetry < 95%

• Bilirubin > 3mg/dL or ALT > 5 x upper limit of normal

• Creatinine > 3x baseline (at transplant)

• ANC (WBC x % neutrophils + bands) < 500/ul

• Significant effusions (eg. pleural or pericardial) or ascites

• EBV-related PTLD

• Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Levine Children's Hospital, Carolinas Medical Center	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Andrew Gilman, MD, Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 14, 2014
• Informed Consent Form - Nov 14, 2014

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01027702
• Other Study ID Numbers: LCH BMT 09-02
• First Posted: Dec 9, 2009
• Last Update Posted: Apr 22, 2022
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Wake Forest University Health Sciences: Donor Lymphocyte Infusion; Immune Recovery; T cell depleted transplant; Mismatched related donor transplants; Unrelated donor transplants
• Additional relevant MeSH terms: Immunologic Deficiency Syndromes

Study Results

Participant Flow

Recruitment Details	Patients who received a CD34+ selected peripheral blood stem cell (PBSC) transplant on the companion study, LCH BMT 09-01, at Levine Children's Hospital between December 2009 and June 2016.
Pre-assignment Detail	Subjects were enrolled to two cohorts based on donor type, Mismatched Related Donor (MMRD) and Matched Unrelated Donor (MUD).

Arm/Group Title	MMRD: 3 x 10^4/kg DLI + MTX to Day +24	MMRD: 3 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +80	MMRD: 5 x 10^4/kg DLI + MTX to Day +80	MUD: 3 x 10^4/kg DLI + MTX to Day +24	MUD: 3 x 10^4/kg DLI + MTX to Day +52
Arm/Group Description	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
Period Title: Overall Study
STARTED	4	4	3	14	10	1	2
COMPLETED	3	2	2	10	9	1	1
NOT COMPLETED	1	2	1	4	1	0	1

Baseline Characteristics

Arm/Group Title	Infusion of Donor Lymphocytes
Arm/Group Description	Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant. Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
Overall Participants	38
Age, Customized (participants) [Number]
< 1 year	2 5.3%
1-2 years	3 7.9%
2-4 years	3 7.9%
4-6 years	3 7.9%
6-8 years	3 7.9%
8-10 years	3 7.9%
10-12 years	4 10.5%
12-14 years	4 10.5%
14-16 years	3 7.9%
16-18 years	6 15.8%
> 18 years	4 10.5%
Sex: Female, Male (Count of Participants)
Female	16 42.1%
Male	22 57.9%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	8 21.1%
African American	19 50%
Hispanic or Latino	10 26.3%
Other	1 2.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Immune Recovery Following Transplantation
Description	Immune recovery was measured by CD4+ cells > 100/μL by Day 120 following transplantation
Time Frame	120 days after transplant

Outcome Measure Data

Analysis Population Description

Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments.

Arm/Group Title	MMRD: 3 x 10^4/kg DLI + MTX to Day +24	MMRD: 3 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +80	MMRD: 5 x 10^4/kg DLI + MTX to Day +80	MUD: 3 x 10^4/kg DLI + MTX to Day +24	MUD: 3 x 10^4/kg DLI + MTX to Day +52
Arm/Group Description	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
Measure Participants	3	2	2	10	9	1	1
Count of Participants [Participants]	1 2.6%	1 NaN	1 NaN	4 NaN	6 NaN	1 NaN	1 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MMRD: 3 x 10^4/kg DLI + MTX to Day +24, MMRD: 3 x 10^4/kg DLI + MTX to Day +52, MMRD: 4 x 10^4/kg DLI + MTX to Day +52, MMRD: 4 x 10^4/kg DLI + MTX to Day +80, MMRD: 5 x 10^4/kg DLI + MTX to Day +80, MUD: 3 x 10^4/kg DLI + MTX to Day +24, MUD: 3 x 10^4/kg DLI + MTX to Day +52
	Comments	This was a dose-escalation study to determine a target DLI dose at which the: Probability of CD4+ cells > 100/µL by Day +120 is at least 66% and Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was: If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified. If none of the initial three patients at a dose level experienced grade II/III GVHD and < 2/3 had a CD4+ count > 100 at Day +120, the next three patients were assigned to the next higher dose level. If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or > 2/3 have a CD4+ count > 100 at Day +120, the dose was repeated for the next 3 patients. The dose of 5 x 10^4 CD3+ cells/kg was determined to be the optimal dose.

2. Primary Outcome

Title	Incidence and Severity of GVHD
Description	Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.
Time Frame	180 days after transplant

Outcome Measure Data

Analysis Population Description

Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint.

Arm/Group Title	MMRD: 3 x 10^4/kg DLI + MTX to Day +24	MMRD: 3 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +52	MMRD: 4 x 10^4/kg DLI + MTX to Day +80	MMRD: 5 x 10^4/kg DLI + MTX to Day +80	MUD: 3 x 10^4/kg DLI + MTX to Day +24	MUD: 3 x 10^4/kg DLI + MTX to Day +52
Arm/Group Description	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24	Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
Measure Participants	3	2	2	10	9	1	1
No GVHD/ Grade I GVHD	2 5.3%	1 NaN	1 NaN	9 NaN	8 NaN	1 NaN	1 NaN
Grade II GVHD	0 0%	1 NaN	1 NaN	1 NaN	1 NaN	0 NaN	0 NaN
Grade III/IV GVHD	1 2.6%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MMRD: 3 x 10^4/kg DLI + MTX to Day +24, MMRD: 3 x 10^4/kg DLI + MTX to Day +52, MMRD: 4 x 10^4/kg DLI + MTX to Day +52, MMRD: 4 x 10^4/kg DLI + MTX to Day +80, MMRD: 5 x 10^4/kg DLI + MTX to Day +80, MUD: 3 x 10^4/kg DLI + MTX to Day +24, MUD: 3 x 10^4/kg DLI + MTX to Day +52
	Comments	This was a dose-escalation study to determine a target DLI dose at which the: Probability of CD4+ cells > 100/µL by Day +120 is at least 66% and Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was: If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified. If none of the initial three patients at a dose level experienced grade II/III GVHD and < 2/3 had a CD4+ count > 100 at Day +120, the next three patients were assigned to the next higher dose level. If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or > 2/3 have a CD4+ count > 100 at Day +120, the dose was repeated for the next 3 patients. The dose of 5 x 10^4 CD3+ cells/kg was determined to be the optimal dose.

3. Secondary Outcome

Title	Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Description	Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections.

Arm/Group Title	Infusion of Donor Lymphocytes
Arm/Group Description	Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant. Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
Measure Participants	38
HHV-6 reactivation, no disease	18 47.4%
Viral upper respiratory infections	17 44.7%
Adenovirus reactivation, no disease	11 28.9%
Clostridium difficile colitis	9 23.7%
Sinusitis	8 21.1%
CMV reactivation, no disease	5 13.2%
Galactomannan positive	5 13.2%
BK virus, no disease	5 13.2%
BK virus, hemorrhagic cystitis	4 10.5%
EBV-related lymphoproliferative disease	4 10.5%
Bacteremia, gram negative	4 10.5%
Herpes simplex virus	4 10.5%
Bacteremia, gram positive	4 10.5%
Acute otitis media	3 7.9%
Candidiasis (non-invasive)	3 7.9%
Pneumonia	3 7.9%
Infection with normal ANC - grade 3	3 7.9%
Adenovirus disease	2 5.3%
EBV reactivation, no disease	2 5.3%
Varicella	2 5.3%
Nocardia	2 5.3%
Pneumonia- fungal	1 2.6%
Methicillin-resistant staphylococcus aureus (MRSA)	1 2.6%
Norovirus	1 2.6%
Parvovirus B19 (low level)	1 2.6%
Rotavirus	1 2.6%
Sapovirus	1 2.6%
Possible respiratory fungal infection (rhizomucor)	1 2.6%

Adverse Events

Time Frame	From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Adverse Event Reporting Description	Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
Arm/Group Title	Infusion of Donor Lymphocytes
Arm/Group Description	Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant. Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
All Cause Mortality
	Infusion of Donor Lymphocytes
	Affected / at Risk (%)	# Events
Total	12/38 (31.6%)
Serious Adverse Events
	Infusion of Donor Lymphocytes
	Affected / at Risk (%)	# Events
Total	32/38 (84.2%)
Blood and lymphatic system disorders
Thrombotic Microangiopathy	2/38 (5.3%)
Cardiac disorders
Pericardial effusion	1/38 (2.6%)
General disorders
Fever	24/38 (63.2%)
Immune system disorders
Graft vs Host disease	5/38 (13.2%)
Infections and infestations
HHV-6 reactivation	6/38 (15.8%)
EBV-related lymphoproliferative disease	4/38 (10.5%)
Pneumonia	3/38 (7.9%)
Gastroenteritis	3/38 (7.9%)
CMV reactivation	2/38 (5.3%)
Infection w/ unknown absolute neutrophil count (ANC)	2/38 (5.3%)
Infection- eye NOS	1/38 (2.6%)
BK virus/ hemorrhagic cystitis	1/38 (2.6%)
Infection- select	1/38 (2.6%)
Investigations
ALT/ AST elevated	1/38 (2.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse	2/25 (8%)
Nervous system disorders
Seizure	1/38 (2.6%)
Renal and urinary disorders
Renal failure	1/38 (2.6%)
Respiratory, thoracic and mediastinal disorders
Pulmonary/ Upper Respiratory- other	1/38 (2.6%)
Hypoxia	1/38 (2.6%)
Pleural effusion	1/38 (2.6%)
Vascular disorders
Hypertension	1/38 (2.6%)
Other (Not Including Serious) Adverse Events
	Infusion of Donor Lymphocytes
	Affected / at Risk (%)	# Events
Total	27/38 (71.1%)
Blood and lymphatic system disorders
Thrombotic microangiopathy	3/38 (7.9%)
Thrombotic microangiopathy	3/38 (7.9%)
General disorders
Pain	2/38 (5.3%)
Investigations
Neutropenia	12/38 (31.6%)
Platelet count decreased	10/38 (26.3%)
Leukopenia	8/38 (21.1%)
Lymphopenia	3/38 (7.9%)
Metabolism and nutrition disorders
ALT elevated	2/38 (5.3%)
Hypokalemia	2/38 (5.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse	6/25 (24%)
Nervous system disorders
Seizures	2/38 (5.3%)
Renal and urinary disorders
Hemorrage, GU- urinary NOS	2/38 (5.3%)
Renal/ Genitorurinary NOS	2/38 (5.3%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	5/38 (13.2%)
Hypoxia	3/38 (7.9%)
Skin and subcutaneous tissue disorders
Rash	4/38 (10.5%)
Vascular disorders
Hypertension	2/38 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.