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Trial record 95 of 144 for:    "Acute promyelocytic leukemia"

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

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: NCT01118013
Recruitment Status : Terminated
First Posted : May 6, 2010
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions Biological: anti-thymocyte globulin
Biological: donor lymphocytes
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Other: reduced-intensity transplant conditioning procedure
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 6
Recruitment Details Between May 2010 and March 2012, 6 participants were recruited.
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
67
(58 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 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
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Event-free Survival (EFS)
Hide Description EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Comparison of EFS Distribution to That of CALGB-100002
Hide Description EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Complete Response Rate
Hide Description Complete response (CR) rate is reported as the percentage of participants who achieved a CR.
Time Frame Up to 5.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Time Frame Up to 5.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Rate of Opportunistic Infections
Hide Description Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.
Time Frame 1 year post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
Arm/Group Title Treatment
Hide Arm/Group Description:

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

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 Treatment
Hide Arm/Group Description

Participants will receive:

Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   3/6 (50.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/6 (16.67%)  1
Cardiac disorders   
Sinus tachycardia  1  1/6 (16.67%)  1
Eye disorders   
Cataract  1  1/6 (16.67%)  1
Flashing lights  1  1/6 (16.67%)  1
Watering eyes  1  1/6 (16.67%)  1
Gastrointestinal disorders   
Nausea  1  1/6 (16.67%)  1
General disorders   
Death NOS  1  1/6 (16.67%)  1
Edema limbs  1  1/6 (16.67%)  1
Fatigue  1  2/6 (33.33%)  2
Fever  1  1/6 (16.67%)  1
Malaise  1  1/6 (16.67%)  1
Non-cardiac chest pain  1  1/6 (16.67%)  1
Pain  1  1/6 (16.67%)  1
Infections and infestations   
Infections and infestations - Other, specify  1  1/6 (16.67%)  1
Upper respiratory infection  1  1/6 (16.67%)  1
Investigations   
Creatinine increased  1  2/6 (33.33%)  2
Neutrophil count decreased  1  1/6 (16.67%)  1
Platelet count decreased  1  2/6 (33.33%)  2
Weight loss  1  1/6 (16.67%)  1
White blood cell decreased  1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/6 (16.67%)  1
Hyperglycemia  1  2/6 (33.33%)  2
Hyperkalemia  1  1/6 (16.67%)  1
Hypocalcemia  1  1/6 (16.67%)  1
Hyponatremia  1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/6 (16.67%)  1
Pain in extremity  1  2/6 (33.33%)  2
Nervous system disorders   
Ataxia  1  1/6 (16.67%)  1
Dysgeusia  1  1/6 (16.67%)  1
Tremor  1  1/6 (16.67%)  1
Psychiatric disorders   
Agitation  1  1/6 (16.67%)  1
Anxiety  1  1/6 (16.67%)  1
Delirium  1  1/6 (16.67%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/6 (16.67%)  1
Hematuria  1  1/6 (16.67%)  1
Renal and urinary disorders - Other, specify  1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/6 (16.67%)  1
Dyspnea  1  1/6 (16.67%)  1
Hypoxia  1  1/6 (16.67%)  1
Pneumonitis  1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders - Other, specify  1  1/6 (16.67%)  1
Skin ulceration  1  1/6 (16.67%)  1
Vascular disorders   
Hypotension  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  6/6 (100.00%)  18
Febrile neutropenia  1  3/6 (50.00%)  3
Cardiac disorders   
Cardiac disorders - Other, specify  1  2/6 (33.33%)  2
Heart failure  1  1/6 (16.67%)  1
Pericardial effusion  1  2/6 (33.33%)  3
Sinus bradycardia  1  1/6 (16.67%)  1
Sinus tachycardia  1  1/6 (16.67%)  3
Ventricular arrhythmia  1  1/6 (16.67%)  1
Ventricular tachycardia  1  1/6 (16.67%)  1
Eye disorders   
Blurred vision  1  1/6 (16.67%)  1
Cataract  1  1/6 (16.67%)  1
Dry eye  1  1/6 (16.67%)  2
Watering eyes  1  1/6 (16.67%)  1
Gastrointestinal disorders   
Constipation  1  3/6 (50.00%)  4
Diarrhea  1  4/6 (66.67%)  7
Dry mouth  1  3/6 (50.00%)  6
Dysphagia  1  1/6 (16.67%)  1
Enterocolitis  1  1/6 (16.67%)  1
Mucositis oral  1  6/6 (100.00%)  6
Nausea  1  3/6 (50.00%)  6
Oral pain  1  3/6 (50.00%)  3
Vomiting  1  3/6 (50.00%)  5
General disorders   
Chills  1  2/6 (33.33%)  2
Edema limbs  1  3/6 (50.00%)  4
Fatigue  1  4/6 (66.67%)  12
Fever  1  3/6 (50.00%)  8
Pain  1  2/6 (33.33%)  3
Infections and infestations   
Catheter related infection  1  2/6 (33.33%)  2
Infections and infestations - Other, specify  1  3/6 (50.00%)  7
Lung infection  1  1/6 (16.67%)  1
Meningitis  1  1/6 (16.67%)  1
Mucosal infection  1  1/6 (16.67%)  1
Sepsis  1  2/6 (33.33%)  2
Upper respiratory infection  1  2/6 (33.33%)  2
Injury, poisoning and procedural complications   
Bruising  1  1/6 (16.67%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  2/6 (33.33%)  2
Alanine aminotransferase increased  1  5/6 (83.33%)  13
Alkaline phosphatase increased  1  3/6 (50.00%)  5
Aspartate aminotransferase increased  1  5/6 (83.33%)  13
Blood bilirubin increased  1  2/6 (33.33%)  2
Cholesterol high  1  1/6 (16.67%)  1
Creatinine increased  1  6/6 (100.00%)  16
GGT increased  1  1/6 (16.67%)  1
INR increased  1  2/6 (33.33%)  2
Investigations - Other, specify  1  2/6 (33.33%)  3
Lymphocyte count decreased  1  1/6 (16.67%)  1
Neutrophil count decreased  1  6/6 (100.00%)  13
Platelet count decreased  1  6/6 (100.00%)  18
Weight loss  1  4/6 (66.67%)  5
White blood cell decreased  1  2/6 (33.33%)  8
Metabolism and nutrition disorders   
Anorexia  1  4/6 (66.67%)  9
Dehydration  1  1/6 (16.67%)  1
Hyperglycemia  1  6/6 (100.00%)  13
Hyperkalemia  1  1/6 (16.67%)  1
Hypermagnesemia  1  1/6 (16.67%)  1
Hypertriglyceridemia  1  1/6 (16.67%)  1
Hyperuricemia  1  1/6 (16.67%)  1
Hypoalbuminemia  1  3/6 (50.00%)  7
Hypocalcemia  1  3/6 (50.00%)  7
Hypokalemia  1  2/6 (33.33%)  9
Hypomagnesemia  1  3/6 (50.00%)  6
Hyponatremia  1  4/6 (66.67%)  10
Hypophosphatemia  1  2/6 (33.33%)  3
Musculoskeletal and connective tissue disorders   
Avascular necrosis  1  1/6 (16.67%)  2
Back pain  1  2/6 (33.33%)  2
Generalized muscle weakness  1  3/6 (50.00%)  3
Myalgia  1  1/6 (16.67%)  1
Pain in extremity  1  1/6 (16.67%)  1
Trismus  1  1/6 (16.67%)  2
Nervous system disorders   
Dizziness  1  2/6 (33.33%)  3
Dysgeusia  1  2/6 (33.33%)  4
Headache  1  1/6 (16.67%)  2
Nervous system disorders - Other, specify  1  2/6 (33.33%)  2
Peripheral sensory neuropathy  1  2/6 (33.33%)  2
Psychiatric disorders   
Confusion  1  2/6 (33.33%)  2
Depression  1  1/6 (16.67%)  4
Insomnia  1  2/6 (33.33%)  3
Renal and urinary disorders   
Acute kidney injury  1  1/6 (16.67%)  1
Chronic kidney disease  1  1/6 (16.67%)  1
Hematuria  1  1/6 (16.67%)  1
Urinary incontinence  1  1/6 (16.67%)  1
Reproductive system and breast disorders   
Genital edema  1  1/6 (16.67%)  1
Reproductive system and breast disorders - Other, specify  1  1/6 (16.67%)  1
Scrotal pain  1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/6 (16.67%)  1
Apnea  1  1/6 (16.67%)  2
Atelectasis  1  2/6 (33.33%)  4
Cough  1  2/6 (33.33%)  4
Dyspnea  1  5/6 (83.33%)  8
Hypoxia  1  1/6 (16.67%)  1
Pleural effusion  1  2/6 (33.33%)  5
Productive cough  1  1/6 (16.67%)  1
Respiratory failure  1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  2/6 (33.33%)  4
Sleep apnea  1  1/6 (16.67%)  1
Sore throat  1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  2/6 (33.33%)  3
Erythema multiforme  1  2/6 (33.33%)  2
Pruritus  1  2/6 (33.33%)  2
Rash maculo-papular  1  4/6 (66.67%)  5
Skin and subcutaneous tissue disorders - Other, specify  1  2/6 (33.33%)  2
Skin hyperpigmentation  1  2/6 (33.33%)  2
Skin ulceration  1  1/6 (16.67%)  1
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  1/6 (16.67%)  1
Vascular disorders   
Hematoma  1  1/6 (16.67%)  1
Hypertension  1  4/6 (66.67%)  9
Hypotension  1  4/6 (66.67%)  6
Thromboembolic event  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Asad Bashey, MD, PhD
Organization: Blood and Marrow Transplant Group of Georgia
EMail: abashey@bmtga.com
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01118013     History of Changes
Other Study ID Numbers: CALGB-100601
CALGB-100601
CDR0000667954 ( Registry Identifier: NCI Physician Data Query )
First Submitted: May 5, 2010
First Posted: May 6, 2010
Results First Submitted: December 12, 2016
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017