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Trial record 100 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps

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ClinicalTrials.gov Identifier: NCT01350258
Recruitment Status : Terminated (Poor accrual)
First Posted : May 9, 2011
Results First Posted : October 24, 2014
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hematologic Malignancies
Acute Leukemia
Myelodysplastic Syndromes (MDS) Other Than RA or RARS Subtypes
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Myeloma
Chronic Myelogenous (or Myeloid) Leukemia (CML) Resistant to STI Therapy
Interventions Drug: Fludarabine
Drug: Thiotepa
Radiation: Total Body Irradiation (TBI)
Biological: Donor Lymphocyte Infusion (DLI)
Drug: Melphalan
Device: Hematopoietic stem cell transplantation (HSCT)
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
60.43  (7.86)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  75.0%
>=65 years
2
  25.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 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
3
  37.5%
White
5
  62.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Phase 1: Defined Dose of Melphalan (MEL)
Hide Description To define the dose of MEL required for the establishment of peripheral T cell tolerance with concomitant immune reconstitution.
Time Frame 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Phase 2: Non-Relapse Mortality (NRM)
Hide Description To evaluate the 100 day non-relapse mortality (NRM) rate in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.
Time Frame 100 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Relapse Rate
Hide Description To compare relapse rates in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.
Time Frame At 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title GVHD Incidence and Severity
Hide Description To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.
Time Frame At 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Engraftment Rate and Lymphoid Reconstitution
Hide Description To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.
Time Frame 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall Survival
Hide Description To assess overall survival in patients undergoing HSCT treated on this trial.
Time Frame At 1 and 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant Treatment Group
Hide Arm/Group Description

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.

TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28.

All-Cause Mortality
Transplant Treatment Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transplant Treatment Group
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Gram negative sepsis  1/8 (12.50%)  1
HHV-6 viremia  1/8 (12.50%)  1
Hyperbilirubinemia  2/8 (25.00%)  2
Orthostatic hypotension  1/8 (12.50%)  1
Sepsis  1/8 (12.50%)  1
Gastrointestinal disorders   
Colitis/enteritis  1/8 (12.50%)  1
Diarrhea  5/8 (62.50%)  5
General disorders   
Fever  2/8 (25.00%)  2
Hypoxia  1/8 (12.50%)  1
Lacunar infarct in pons  1/8 (12.50%)  1
Hepatobiliary disorders   
Increased LFTs  1/8 (12.50%)  1
Liver failure  1/8 (12.50%)  1
Immune system disorders   
CMV reactivation  2/8 (25.00%)  2
Renal and urinary disorders   
Renal failure  2/8 (25.00%)  2
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1/8 (12.50%)  1
Respiratory failure  1/8 (12.50%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transplant Treatment Group
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Fluid overload  1/8 (12.50%)  1
HHV-6 viremia  2/8 (25.00%)  2
Hyperbilirubinemia  1/8 (12.50%)  1
Hyperglycemia  1/8 (12.50%)  1
Hypernatremia  3/8 (37.50%)  4
Hyperphosphatemia  1/8 (12.50%)  1
Hypertension  5/8 (62.50%)  5
Hypocalcemia  1/8 (12.50%)  1
Hypokalemia  3/8 (37.50%)  3
Hypomagnesemia  1/8 (12.50%)  1
Hyponatremia  1/8 (12.50%)  1
Hypotension  4/8 (50.00%)  4
Increased creatinine  3/8 (37.50%)  3
Orthostatic hypotension  2/8 (25.00%)  2
Pericatheter thrombus  1/8 (12.50%)  1
Cardiac disorders   
Arrhythmia  1/8 (12.50%)  1
Atrial fibrillation  2/8 (25.00%)  3
Bradycardia  1/8 (12.50%)  1
Coronary artery disease  1/8 (12.50%)  1
Tachycardia  5/8 (62.50%)  6
Volume overload  3/8 (37.50%)  3
Ear and labyrinth disorders   
Ear fullness  1/8 (12.50%)  1
Eye disorders   
Blurred vision  1/8 (12.50%)  1
Changes in vision  1/8 (12.50%)  1
Dry eyes  1/8 (12.50%)  1
Eye movement abnormality  1/8 (12.50%)  1
Eye tearing  1/8 (12.50%)  1
Photophobia  1/8 (12.50%)  1
Ptosis  1/8 (12.50%)  1
Gastrointestinal disorders   
Acute pancreatitis  1/8 (12.50%)  1
Bloating  2/8 (25.00%)  2
Blood in stool  2/8 (25.00%)  2
Bowel obstruction  1/8 (12.50%)  1
Constipation  3/8 (37.50%)  4
Diarrhea  6/8 (75.00%)  10
Dysphagia  1/8 (12.50%)  1
Erythematous mucosa in duodenal bulb  1/8 (12.50%)  1
Gastroesophageal reflux disease  2/8 (25.00%)  2
Ileus  1/8 (12.50%)  1
Mucositis  5/8 (62.50%)  5
Occult blood  2/8 (25.00%)  2
Stomach fluttering  1/8 (12.50%)  1
General disorders   
Abdominal cramping  1/8 (12.50%)  1
Abdominal pain  6/8 (75.00%)  7
Anorexia  2/8 (25.00%)  2
Back pain  2/8 (25.00%)  2
Balance problems  1/8 (12.50%)  1
Body aches  1/8 (12.50%)  1
Buttocks wound  1/8 (12.50%)  1
Chest discomfort  1/8 (12.50%)  1
Chest pain  2/8 (25.00%)  2
Decreased appetite  1/8 (12.50%)  2
Dehydration  1/8 (12.50%)  1
Dizziness  2/8 (25.00%)  2
Dry mouth  2/8 (25.00%)  4
Dry nose/sinuses  1/8 (12.50%)  1
Electrolyte imbalance  2/8 (25.00%)  2
Face/upper neck swelling  1/8 (12.50%)  1
Fatigue  6/8 (75.00%)  6
Feels "fuzzy"  1/8 (12.50%)  1
Feet/ankle/leg swelling  2/8 (25.00%)  3
Fever  7/8 (87.50%)  20
Flank pain  1/8 (12.50%)  1
Flu-like symptoms  1/8 (12.50%)  1
Headache  5/8 (62.50%)  8
Hiccups  2/8 (25.00%)  3
Hypothermia  3/8 (37.50%)  4
Hypoxia  3/8 (37.50%)  3
Insomnia  3/8 (37.50%)  4
Itchiness in throat  1/8 (12.50%)  1
Leg pain  1/8 (12.50%)  1
Lethargy  1/8 (12.50%)  1
Lightheadedness  1/8 (12.50%)  1
Malaise  1/8 (12.50%)  1
Mental status change  5/8 (62.50%)  7
Nausea  6/8 (75.00%)  8
Oral discomfort  1/8 (12.50%)  1
Pain at PEG tube site  1/8 (12.50%)  1
Post nasal drip  1/8 (12.50%)  1
Purulent drainage  1/8 (12.50%)  1
Rigors/chills  4/8 (50.00%)  4
Shoulder pain  1/8 (12.50%)  1
Sore throat  2/8 (25.00%)  2
Sweats  1/8 (12.50%)  1
Syncope  1/8 (12.50%)  1
Tenderness at PICC site  1/8 (12.50%)  1
Tingling in lips  1/8 (12.50%)  1
Tremors  3/8 (37.50%)  3
Trouble sleeping  2/8 (25.00%)  2
Vision - flashing lights  1/8 (12.50%)  1
Vomiting  2/8 (25.00%)  2
Weight loss  1/8 (12.50%)  1
Wrist tenderness  1/8 (12.50%)  1
Hepatobiliary disorders   
Cholecystitis  1/8 (12.50%)  1
Increased LFTs  2/8 (25.00%)  3
Hepatitis  1/8 (12.50%)  1
Immune system disorders   
CMV reactivation  1/8 (12.50%)  1
Infections and infestations   
Thrush  2/8 (25.00%)  2
Metabolism and nutrition disorders   
Malnutrition  2/8 (25.00%)  2
Metabolic acidosis  4/8 (50.00%)  4
Musculoskeletal and connective tissue disorders   
Bone pain  1/8 (12.50%)  1
Joint pain  2/8 (25.00%)  2
Muscle pain  3/8 (37.50%)  3
Nervous system disorders   
Neuropathy  1/8 (12.50%)  1
Psychiatric disorders   
Anxiety  7/8 (87.50%)  7
Depression  2/8 (25.00%)  2
Disturbing dreams  1/8 (12.50%)  1
Vivid dreams/hallucinations  1/8 (12.50%)  1
Renal and urinary disorders   
Acute kidney injury  2/8 (25.00%)  2
Decreased urine output  2/8 (25.00%)  3
Dysuria  1/8 (12.50%)  1
Hematuria  1/8 (12.50%)  1
Nocturia  2/8 (25.00%)  2
Renal failure  2/8 (25.00%)  2
Urinary incontinence  1/8 (12.50%)  1
Urinary retention  2/8 (25.00%)  2
Urinary urgency  1/8 (12.50%)  1
Reproductive system and breast disorders   
Scrotal swelling  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  3/8 (37.50%)  3
Dyspnea  6/8 (75.00%)  8
Non-productive cough  1/8 (12.50%)  1
Pleural effusion  1/8 (12.50%)  1
Pulmonary edema  1/8 (12.50%)  1
Respiratory crackles  1/8 (12.50%)  1
Respiratory distress  1/8 (12.50%)  1
Rhinorrhea  1/8 (12.50%)  1
Sinus congestion  1/8 (12.50%)  1
Wheezing  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Blister at PICC site  1/8 (12.50%)  1
Dry skin  2/8 (25.00%)  2
Edema  3/8 (37.50%)  3
Hematoma  1/8 (12.50%)  1
Hyperpigmentation  2/8 (25.00%)  3
Pressure ulcer  1/8 (12.50%)  1
Pruritis  3/8 (37.50%)  3
Psoriasis  1/8 (12.50%)  1
Rash  6/8 (75.00%)  12
Skin tear  1/8 (12.50%)  1
Tissue wound  1/8 (12.50%)  1
Study was terminated due to extreme toxicity. The study was closed before any data could be collected.
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: Dolores Grosso, CRNP, DNP
Organization: Thomas Jefferson University
Phone: 215-955-8874
EMail: Dolores.Grosso@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01350258     History of Changes
Other Study ID Numbers: 10D.535
2010-40 ( Other Identifier: CCRRC )
First Submitted: May 4, 2011
First Posted: May 9, 2011
Results First Submitted: October 21, 2014
Results First Posted: October 24, 2014
Last Update Posted: November 29, 2016