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Trial record 63 of 73 for:    "Paroxysmal Nocturnal Hemoglobinuria"

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00975975
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Myelodysplasia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Multiple Myeloma
Myelofibrosis
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Intervention Drug: Basiliximab
Enrollment 17
Recruitment Details This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.
Pre-assignment Details  
Arm/Group Title Overall
Hide Arm/Group Description Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Period Title: Overall Study
Started 17
Completed 11
Not Completed 6
Reason Not Completed
Death             6
Arm/Group Title Overall
Hide Arm/Group Description Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
59.1  (7.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
8
  47.1%
Male
9
  52.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
17
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Grade 3-4 Acute GVHD Rate
Hide Description The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Time Frame Transplant (Day 0) up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled and received treatment
Arm/Group Title Overall
Hide Arm/Group Description:
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.4
(10.3 to 56.0)
2.Secondary Outcome
Title Time to Neutrophil Engraftment
Hide Description Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time Frame Transplant (Day 0) up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.
Arm/Group Title Overall
Hide Arm/Group Description:
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: days
13.5
(10.0 to 14.0)
3.Secondary Outcome
Title Time to Platelet Engraftment
Hide Description Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
Time Frame Transplant (Day 0) up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.
Arm/Group Title Overall
Hide Arm/Group Description:
Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: days
12.0
(8.0 to 18.0)
Time Frame From transplant until the end of the study, for up to 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   7/17 (41.18%) 
Cardiac disorders   
CARDIAC ARRHYTHMIA - OTHER * 1  1/17 (5.88%) 
CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE * 1  1/17 (5.88%) 
Gastrointestinal disorders   
DIARRHEA * 1  2/17 (11.76%) 
GASTROINTESTINAL - OTHER * 1  1/17 (5.88%) 
PAIN - ABDOMEN NOS * 1  2/17 (11.76%) 
General disorders   
FATIGUE (ASTHENIA, LETHARGY, MALAISE) * 1  1/17 (5.88%) 
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  2/17 (11.76%) 
Immune system disorders   
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) * 1  1/17 (5.88%) 
Infections and infestations   
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E * 1  1/17 (5.88%) 
INFECTION - OTHER * 1  4/17 (23.53%) 
INFECTION WITH UNKNOWN ANC - BLOOD * 1  2/17 (11.76%) 
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS * 1  1/17 (5.88%) 
Injury, poisoning and procedural complications   
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED) * 1  1/17 (5.88%) 
Investigations   
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) * 1  1/17 (5.88%) 
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) * 1  1/17 (5.88%) 
CREATININE * 1  2/17 (11.76%) 
PLATELETS * 1  1/17 (5.88%) 
Metabolism and nutrition disorders   
DEHYDRATION * 1  1/17 (5.88%) 
Nervous system disorders   
PAIN - HEAD/HEADACHE * 1  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) * 1  1/17 (5.88%) 
HYPOXIA * 1  2/17 (11.76%) 
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) * 1  1/17 (5.88%) 
Skin and subcutaneous tissue disorders   
RASH/DESQUAMATION * 1  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall
Affected / at Risk (%)
Total   17/17 (100.00%) 
Blood and lymphatic system disorders   
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) * 1  3/17 (17.65%) 
LYMPHATICS - OTHER * 1  1/17 (5.88%) 
PALPITATIONS * 1  1/17 (5.88%) 
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA) * 1  1/17 (5.88%) 
Cardiac disorders   
CARDIAC ARRHYTHMIA - OTHER * 1  3/17 (17.65%) 
CARDIAC GENERAL - OTHER * 1  1/17 (5.88%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION * 1  2/17 (11.76%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA * 1  1/17 (5.88%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA * 1  3/17 (17.65%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA * 1  5/17 (29.41%) 
VENTRICULAR ARRHYTHMIA - PVCS * 1  1/17 (5.88%) 
Ear and labyrinth disorders   
AUDITORY/EAR - OTHER * 1  2/17 (11.76%) 
Endocrine disorders   
ADRENAL INSUFFICIENCY * 1  1/17 (5.88%) 
Eye disorders   
DRY EYE SYNDROME * 1  1/17 (5.88%) 
OCULAR/VISUAL - OTHER * 1  1/17 (5.88%) 
VISION-BLURRED VISION * 1  2/17 (11.76%) 
VITREOUS HEMORRHAGE * 1  1/17 (5.88%) 
Gastrointestinal disorders   
CONSTIPATION * 1  4/17 (23.53%) 
DIARRHEA * 1  14/17 (82.35%) 
DISTENSION/BLOATING, ABDOMINAL * 1  3/17 (17.65%) 
DYSPHAGIA (DIFFICULTY SWALLOWING) * 1  3/17 (17.65%) 
ESOPHAGITIS * 1  1/17 (5.88%) 
FLATULENCE * 1  1/17 (5.88%) 
GASTROINTESTINAL - OTHER * 1  2/17 (11.76%) 
HEARTBURN/DYSPEPSIA * 1  2/17 (11.76%) 
HEMORRHOIDS * 1  3/17 (17.65%) 
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION) * 1  2/17 (11.76%) 
NAUSEA * 1  11/17 (64.71%) 
PAIN - ABDOMEN NOS * 1  6/17 (35.29%) 
PAIN - DENTAL/TEETH/PERIDONTAL * 1  2/17 (11.76%) 
ULCER, GI - ESOPHAGUS * 1  1/17 (5.88%) 
VOMITING * 1  10/17 (58.82%) 
General disorders   
FATIGUE (ASTHENIA, LETHARGY, MALAISE) * 1  3/17 (17.65%) 
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE * 1  8/17 (47.06%) 
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  14/17 (82.35%) 
HOT FLASHES/FLUSHES * 1  1/17 (5.88%) 
HYPOTHERMIA * 1  1/17 (5.88%) 
PAIN - OTHER * 1  8/17 (47.06%) 
RIGORS/CHILLS * 1  4/17 (23.53%) 
SWEATING (DIAPHORESIS) * 1  3/17 (17.65%) 
Hepatobiliary disorders   
ASCITES (NON-MALIGNANT) * 1  2/17 (11.76%) 
BILIRUBIN (HYPERBILIRUBINEMIA) * 1  14/17 (82.35%) 
Immune system disorders   
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) * 1  2/17 (11.76%) 
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) * 1  2/17 (11.76%) 
Infections and infestations   
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E * 1  1/17 (5.88%) 
INFECTION - OTHER * 1  14/17 (82.35%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD * 1  1/17 (5.88%) 
INFECTION WITH UNKNOWN ANC - BLOOD * 1  2/17 (11.76%) 
INFECTION WITH UNKNOWN ANC - COLON * 1  1/17 (5.88%) 
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) * 1  2/17 (11.76%) 
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS) * 1  1/17 (5.88%) 
INFECTION WITH UNKNOWN ANC - SINUS * 1  2/17 (11.76%) 
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS) * 1  1/17 (5.88%) 
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS * 1  6/17 (35.29%) 
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS * 1  5/17 (29.41%) 
Injury, poisoning and procedural complications   
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED) * 1  1/17 (5.88%) 
Investigations   
ALKALINE PHOSPHATASE * 1  12/17 (70.59%) 
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) * 1  14/17 (82.35%) 
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) * 1  14/17 (82.35%) 
CREATININE * 1  14/17 (82.35%) 
IRON OVERLOAD * 1  1/17 (5.88%) 
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY * 1  5/17 (29.41%) 
Metabolism and nutrition disorders   
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) * 1  7/17 (41.18%) 
ANOREXIA * 1  2/17 (11.76%) 
CALCIUM, SERUM-HIGH (HYPERCALCEMIA) * 1  1/17 (5.88%) 
CALCIUM, SERUM-LOW (HYPOCALCEMIA) * 1  4/17 (23.53%) 
DEHYDRATION * 1  1/17 (5.88%) 
EDEMA: HEAD AND NECK * 1  2/17 (11.76%) 
EDEMA: LIMB * 1  14/17 (82.35%) 
EDEMA: TRUNK/GENITAL * 1  1/17 (5.88%) 
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) * 1  9/17 (52.94%) 
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA) * 1  1/17 (5.88%) 
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) * 1  6/17 (35.29%) 
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA) * 1  3/17 (17.65%) 
POTASSIUM, SERUM-HIGH (HYPERKALEMIA) * 1  1/17 (5.88%) 
POTASSIUM, SERUM-LOW (HYPOKALEMIA) * 1  4/17 (23.53%) 
SODIUM, SERUM-LOW (HYPONATREMIA) * 1  4/17 (23.53%) 
Musculoskeletal and connective tissue disorders   
ARTHRITIS (NON-SEPTIC) * 1  1/17 (5.88%) 
JOINT-FUNCTION * 1  1/17 (5.88%) 
MUSCULOSKELETAL/SOFT TISSUE - OTHER * 1  3/17 (17.65%) 
OSTEOPOROSIS * 1  1/17 (5.88%) 
PAIN - BACK * 1  4/17 (23.53%) 
PAIN - BONE * 1  3/17 (17.65%) 
PAIN - EXTREMITY-LIMB * 1  6/17 (35.29%) 
PAIN - JOINT * 1  4/17 (23.53%) 
PAIN - MUSCLE * 1  2/17 (11.76%) 
PAIN - NECK * 1  2/17 (11.76%) 
Nervous system disorders   
CONFUSION * 1  3/17 (17.65%) 
CONSTIPATION * 1  1/17 (5.88%) 
DIZZINESS * 1  4/17 (23.53%) 
ENCEPHALOPATHY * 1  1/17 (5.88%) 
INSOMNIA * 1  3/17 (17.65%) 
NEUROLOGY - OTHER * 1  3/17 (17.65%) 
NEUROPATHY: MOTOR * 1  1/17 (5.88%) 
NEUROPATHY: SENSORY * 1  2/17 (11.76%) 
PAIN - HEAD/HEADACHE * 1  7/17 (41.18%) 
SEIZURE * 1  1/17 (5.88%) 
TREMOR * 1  7/17 (41.18%) 
Psychiatric disorders   
MOOD ALTERATION - ANXIETY * 1  1/17 (5.88%) 
MOOD ALTERATION - DEPRESSION * 1  4/17 (23.53%) 
PSYCHOSIS (HALLUCINATIONS/DELUSIONS) * 1  2/17 (11.76%) 
Renal and urinary disorders   
BLADDER SPASMS * 1  1/17 (5.88%) 
PAIN - BLADDER * 1  2/17 (11.76%) 
RENAL FAILURE * 1  2/17 (11.76%) 
RENAL/GENITOURINARY - OTHER * 1  3/17 (17.65%) 
URINE COLOR CHANGE * 1  1/17 (5.88%) 
Reproductive system and breast disorders   
SEXUAL/REPRODUCTIVE FUNCTION - OTHER * 1  1/17 (5.88%) 
VAGINAL DRYNESS * 1  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
APNEA * 1  1/17 (5.88%) 
ASPIRATION * 1  1/17 (5.88%) 
BRONCHOSPASM, WHEEZING * 1  2/17 (11.76%) 
COUGH * 1  9/17 (52.94%) 
DYSPNEA (SHORTNESS OF BREATH) * 1  12/17 (70.59%) 
HICCOUGHS (HICCUPS, SINGULTUS) * 1  3/17 (17.65%) 
HYPOXIA * 1  9/17 (52.94%) 
PAIN - CHEST WALL * 1  3/17 (17.65%) 
PAIN - CHEST/THORAX NOS * 1  1/17 (5.88%) 
PAIN - THROAT/PHARYNX/LARYNX * 1  3/17 (17.65%) 
PLEURAL EFFUSION (NON-MALIGNANT) * 1  5/17 (29.41%) 
PULMONARY/UPPER RESPIRATORY - OTHER * 1  3/17 (17.65%) 
Skin and subcutaneous tissue disorders   
DERMATOLOGY/SKIN - OTHER * 1  3/17 (17.65%) 
HAIR LOSS/ALOPECIA (SCALP OR BODY) * 1  2/17 (11.76%) 
PRURITUS/ITCHING * 1  5/17 (29.41%) 
RASH/DESQUAMATION * 1  11/17 (64.71%) 
RASH: ACNE/ACNEIFORM * 1  3/17 (17.65%) 
SKIN BREAKDOWN/DECUBITUS ULCER * 1  2/17 (11.76%) 
Vascular disorders   
HEMORRHAGE, GI - LOWER GI NOS * 1  3/17 (17.65%) 
HEMORRHAGE, GI - VARICES (RECTAL) * 1  1/17 (5.88%) 
HEMORRHAGE, GU - BLADDER * 1  1/17 (5.88%) 
HEMORRHAGE, GU - URINARY NOS * 1  2/17 (11.76%) 
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE * 1  2/17 (11.76%) 
HEMORRHAGE/BLEEDING - OTHER * 1  3/17 (17.65%) 
HYPERTENSION * 1  5/17 (29.41%) 
HYPOTENSION * 1  5/17 (29.41%) 
THROMBOSIS/THROMBUS/EMBOLISM * 1  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Robert Nelson
Organization: IndianaU
Phone: 317-944-0920
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00975975     History of Changes
Other Study ID Numbers: 0908-04; IUCRO-0256
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: January 28, 2016
Results First Posted: February 26, 2016
Last Update Posted: February 26, 2016