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Trial record 80 of 523 for:    stem cell kidney

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00698685
Recruitment Status : Terminated (Pentostatin/alemtuzumab regimen had greater risk of graft failure.)
First Posted : June 17, 2008
Results First Posted : January 12, 2011
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Hodgkin's Disease
Hematologic Neoplasms
Multiple Myeloma
Carcinoma, Renal Cell
Interventions Drug: Pentostatin
Biological: Alemtuzumab
Procedure: Allogeneic hematopoietic stem cell transplantation
Enrollment 14
Recruitment Details Following University of Arizona IRB review and approval, the study opened to accrual on November 2005 at the Arizona Cancer Center clinic and University Medical Center sites [Tucson, Arizona].
Pre-assignment Details Following consent process, subjects who consented to participate were screened per the selection criteria in the study.
Arm/Group Title Preparative Regimen of Pentostatin and Alemtuzumab
Hide Arm/Group Description

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.

Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

Period Title: Overall Study
Started 14
Completed 12
Not Completed 2
Reason Not Completed
Sister withdrew as donor             1
Off study pre transplant by clinic MD             1
Arm/Group Title Preparative Regimen of Pentostatin and Alemtuzumab
Hide Arm/Group Description

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.

Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  78.6%
>=65 years
3
  21.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
5
  35.7%
Male
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).
Hide Description The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.
Time Frame Day 100 after transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed treatment and underwent allogeneic transplant.
Arm/Group Title Preparative Regimen of Pentostatin and Alemtuzumab
Hide Arm/Group Description:

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.

Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Preparative Regimen of Pentostatin and Alemtuzumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter actuarial probability of engraftment
Estimated Value 70
Estimation Comments Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.
2.Primary Outcome
Title Non-relapse Mortality at or Before Day 100
Hide Description The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin’s disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).
Time Frame Day 100 after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 day of treatment.
Arm/Group Title Preparative Regimen of Pentostatin and Alemtuzumab
Hide Arm/Group Description:

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.

Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
3
Time Frame Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse Event Reporting Description Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
 
Arm/Group Title Preparative Regimen of Pentostatin and Alemtuzumab
Hide Arm/Group Description

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.

Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

All-Cause Mortality
Preparative Regimen of Pentostatin and Alemtuzumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Preparative Regimen of Pentostatin and Alemtuzumab
Affected / at Risk (%) # Events
Total   8/13 (61.54%)    
Blood and lymphatic system disorders   
metabolic/laboratory: elevated AST and ALT  [1]  1/13 (7.69%)  1
hyperbilirubinemia  [2]  1/13 (7.69%)  1
Cardiac disorders   
Death on study, post BMT  [3]  1/13 (7.69%)  1
Infections and infestations   
altered mental status and progressive obtundation [disseminated toxoplasmosis]  [4]  1/13 (7.69%)  1
disseminated toxoplasmosis  [5]  1/13 (7.69%)  1
Renal and urinary disorders   
hemorrhagic cystitis associated with BK virus  [6]  1/13 (7.69%)  1
thrombotic microangiopathy  [7]  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
hypoxia and dyspnea which was a result of pulmonary hemorrhage  [8]  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
These blood chemistries returned to normal within several days after cessation of pentostatin infusion and without specific intervention: probably associated with the infusion of pentostatin.
[2]
Due to progressive hepatic infiltration by Hodgkin's disease and felt to be an expected SAE that was related to subject's aggressive underlying malignancy and unrelated to investigational treatment.
[3]
Cardiac and respiratory failure.
[4]
After extensive evaluation, determined subject had disseminated toxoplasmosis. Subject died shortly after initiation of definitive therapy for toxoplasmosis. Assessed expected SAE [infections] and possibly related to investigational treatment.
[5]
Subject had persistent fevers and disseminated toxoplasmosis determined by quantitative PCR on a blood sample. Assessed as expected SAE (infections)and possibly related to investigational treatment.
[6]
Developed about 50 days after unrelated PBPCT;required hospital stay for continuous bladder irrigation and transfusions of red cells and platelets; also had elective cystoscopy, at which time clot was evacuated from the bladder. Possibly related.
[7]
Developed in May 2009 about 6 months after administration of investigational treatment and required hemodialysis. Assessed as expected SAE and unrelated to the investigational treatment.
[8]
Occurred without evidence of donor engraftment. subject had comorbidities [i.e., coronary artery disease] died with multisystem failure. Assessed as expected SAE and was possibly related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Preparative Regimen of Pentostatin and Alemtuzumab
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Blood/Bone Marrow  1  5/13 (38.46%)  63
DIC (disseminated intravascular coagulation)  1  1/13 (7.69%)  1
Edema: limb  1  4/13 (30.77%)  9
Edema: viscera  1  1/13 (7.69%)  1
Fibrinogen  1  1/13 (7.69%)  1
Hemoglobin  1  8/13 (61.54%)  36
Leukocytes (total WBC)  1  4/13 (30.77%)  8
Lymphatics  1  8/13 (61.54%)  17
Lymphopenia  1  1/13 (7.69%)  1
Neutrophils/granulocytes (ANC/AGC)  1  1/13 (7.69%)  1
Platelets  1  7/13 (53.85%)  35
PTT (Partial Thromboplastin Time)  1  2/13 (15.38%)  2
Cardiac disorders   
Cardiac General  1  6/13 (46.15%)  10
Cardiac Arrhythmia  1  1/13 (7.69%)  1
Cardiac troponin T (cTnT)  1  1/13 (7.69%)  2
Hypertension  1  5/13 (38.46%)  7
Hypotension  1  4/13 (30.77%)  5
Pericardial effusion (non-malignant)  1  1/13 (7.69%)  1
Supraventricular and nodal arrhythmia  1  2/13 (15.38%)  4
Ventricular arrhythmia  1  1/13 (7.69%)  1
Eye disorders   
Death not associated with CTCAE term  1  1/13 (7.69%)  1
Ocular/Visual  1  3/13 (23.08%)  4
Vision-photophobia  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Anorexia  1  3/13 (23.08%)  7
Constipation  1  4/13 (30.77%)  9
Dehydration  1  2/13 (15.38%)  2
Diarrhea  1  2/13 (15.38%)  3
Flatulence  1  1/13 (7.69%)  2
Gastritis (including bile reflux gastritis)  1  1/13 (7.69%)  1
Gastrointestinal  1  6/13 (46.15%)  33
Heartburn/dyspepsia  1  1/13 (7.69%)  1
Nausea  1  6/13 (46.15%)  22
Vomiting  1  5/13 (38.46%)  12
General disorders   
Constitutional Symptoms  1  7/13 (53.85%)  33
Fatigue (asthenia, lethargy, malaise)  1  4/13 (30.77%)  5
Fever (in the absence of neutropenia, where neutropenia is defined as ANC >1.0 x="" 10e9=""/L)  1  6/13 (46.15%)  13
Insomnia  1  4/13 (30.77%)  10
Pain  1  12/13 (92.31%)  98
Rigors/chills  1  5/13 (38.46%)  7
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  2/13 (15.38%)  2
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  2/13 (15.38%)  2
Allergy/Immunology  1  3/13 (23.08%)  6
Autoimmune reaction  1  1/13 (7.69%)  2
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  2/13 (15.38%)  2
Infection  1  8/13 (61.54%)  20
Infection with normal ANC or Grade 1 or 2 neutrophils  1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory)  1  1/13 (7.69%)  2
Albumin, serum-low (hypoalbuminemia)  1  3/13 (23.08%)  12
Alkaline phosphatase, increased  1  1/13 (7.69%)  1
ALT, SGPT (serum glutamic pyruvic transaminase), increased  1  6/13 (46.15%)  8
AST, SGOT(serum glutamic oxaloacetic transaminase), increased  1  6/13 (46.15%)  7
Bicarbonate, serum-low  1  2/13 (15.38%)  10
Bilirubin (hyperbilirubinemia)  1  2/13 (15.38%)  2
Calcium, serum-low (hypocalcemia)  1  2/13 (15.38%)  4
Creatinine, increased  1  6/13 (46.15%)  18
Glucose, serum-high (hyperglycemia)  1  4/13 (30.77%)  36
Magnesium, serum-low (hypomagnesemia)  1  7/13 (53.85%)  40
Metabolic/Laboratory  1  10/13 (76.92%)  84
Phosphate, serum-low (hypophosphatemia)  1  2/13 (15.38%)  3
Potassium, serum-high (hyperkalemia)  1  1/13 (7.69%)  1
Potassium, serum-low (hypokalemia)  1  7/13 (53.85%)  19
Sodium, serum-high (hypernatremia)  1  1/13 (7.69%)  1
Sodium, serum-low (hyponatremia)  1  3/13 (23.08%)  5
Uric acid, serum-high (hyperuricemia)  1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue  1  2/13 (15.38%)  2
Nervous system disorders   
Confusion  1  2/13 (15.38%)  3
Dizziness  1  1/13 (7.69%)  1
Extrapyramidal/involuntary movement/restlessness  1  1/13 (7.69%)  1
Mood alteration  1  4/13 (30.77%)  10
Neurology  1  6/13 (46.15%)  14
Neuropathy: sensory  1  1/13 (7.69%)  1
Speech impairment (e.g., dysphasia or aphasia)  1  1/13 (7.69%)  1
Tremor  1  1/13 (7.69%)  1
Renal and urinary disorders   
Bladder spasms  1  1/13 (7.69%)  1
Cystitis  1  1/13 (7.69%)  1
Renal failure  1  4/13 (30.77%)  7
Renal/Genitourinary  1 [1]  5/13 (38.46%)  7
Urinary frequency/urgency  1  1/13 (7.69%)  1
Urinary retention (including neurogenic bladder)  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/13 (15.38%)  2
Dyspnea (shortness of breath)  1  2/13 (15.38%)  7
Hemorrhage, pulmonary/upper respiratory  1  1/13 (7.69%)  1
Hemorrhage/Bleeding  1  1/13 (7.69%)  1
Hypoxia  1  1/13 (7.69%)  3
Pleural effusion (non-malignant)  1  1/13 (7.69%)  2
Pulmonary/Upper Respiratory  1  7/13 (53.85%)  28
Skin and subcutaneous tissue disorders   
Cytokine release syndrome/acute infusion reaction  1  1/13 (7.69%)  1
Dermatology/Skin  1  8/13 (61.54%)  18
Flushing  1  1/13 (7.69%)  1
Pruritus/itching  1  2/13 (15.38%)  2
Rash/desquamation  1  1/13 (7.69%)  1
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  1/13 (7.69%)  1
Surgical and medical procedures   
Hemorrhage/Bleeding  1  2/13 (15.38%)  3
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/13 (7.69%)  2
Vascular  1 [2]  4/13 (30.77%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Hematuria, anuria, renal insufficiency, urinary tract infection.
[2]
Increased [cyclosporine] CSA level, jugular venous distention, port occlusion [2].
We did not meet criteria to stop the study because of nonrelapse mortality (safety endpoint). However, we stopped accrual to the study because of failure to meet minimal criteria for engraftment (efficacy endpoint).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew M. Yeager, MD
Organization: University of Arizona, Arizona Cancer Center
Phone: 520-626-0662
EMail: ayeager@azcc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00698685     History of Changes
Obsolete Identifiers: NCT00543283
Other Study ID Numbers: 05-0624-04
R21CA106177 ( U.S. NIH Grant/Contract )
05110 ( Other Identifier: University of Arizona )
UARIZ-05-0624-01 ( Other Identifier: University of Arizona )
UARIZ-SRC17920 ( Other Identifier: Arizona Cancer Center )
First Submitted: June 14, 2008
First Posted: June 17, 2008
Results First Submitted: December 28, 2010
Results First Posted: January 12, 2011
Last Update Posted: March 31, 2017