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Trial record 29 of 53 for:    "Adult Acute Lymphocytic Leukemia" | "Methylprednisolone hemisuccinate"

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic 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: NCT00281879
Recruitment Status : Terminated
First Posted : January 25, 2006
Results First Posted : June 19, 2012
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard Maziarz, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unusual Cancers of Childhood
Interventions Biological: anti-thymocyte globulin
Biological: filgrastim
Drug: busulfan
Drug: carmustine
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Drug: methylprednisolone
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: radiation therapy
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Hide Arm/Group Description On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI). On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI). A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells. On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein. If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion. Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s. On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
Period Title: Overall Study
Started 128 36 20 0 6 9 0 1
Completed 0 0 0 0 0 0 0 0
Not Completed 128 36 20 0 6 9 0 1
Arm/Group Title Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only) Total
Hide Arm/Group Description On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI). On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI). A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells. On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein. If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion. Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s. On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells. Total of all reporting groups
Overall Number of Baseline Participants 128 36 20 0 6 9 0 1 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 36 participants 20 participants 0 participants 6 participants 9 participants 0 participants 1 participants 200 participants
<=18 years
27
  21.1%
1
   2.8%
0
   0.0%
6
 100.0%
7
  77.8%
1
 100.0%
42
  21.0%
Between 18 and 65 years
101
  78.9%
35
  97.2%
20
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
156
  78.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
2
   1.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 36 participants 20 participants 0 participants 6 participants 9 participants 0 participants 1 participants 200 participants
32.033  (14.923) 48.33  (11.67) 46.187  (12.87) 12.22  (7.90) 11.77  (10.725) 5.42  (0) 34.743  (16.818)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 36 participants 20 participants 0 participants 6 participants 9 participants 0 participants 1 participants 200 participants
Female
56
  43.8%
13
  36.1%
3
  15.0%
4
  66.7%
5
  55.6%
1
 100.0%
82
  41.0%
Male
72
  56.3%
23
  63.9%
17
  85.0%
2
  33.3%
4
  44.4%
0
   0.0%
118
  59.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 128 participants 36 participants 20 participants 0 participants 6 participants 9 participants 0 participants 1 participants 200 participants
128 36 20 6 9 1 200
1.Primary Outcome
Title Number of Participants With Disease Free Survival (DFS).
Hide Description

Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.

Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer.

Time Frame Duration of the study; Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Hide Arm/Group Description On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI). On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI). A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells. On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein. If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion. Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s. On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
All-Cause Mortality
Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/128 (78.91%)      25/36 (69.44%)      17/20 (85.00%)      0/0      5/6 (83.33%)      6/9 (66.67%)      0/0      1/1 (100.00%)    
Blood and lymphatic system disorders                 
Staph Sepsis  3/128 (2.34%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Thrombocytopenia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Orthostatic Hypertension  3/128 (2.34%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Positive blood cultures  2/128 (1.56%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Cardiac disorders                 
Cardiac Problems  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Tachycardia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Gastrointestinal disorders                 
Graft versus host disease (GVHD)  17/128 (13.28%)  13/36 (36.11%)  3/20 (15.00%)  0/0  0 1/6 (16.67%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Gastroenteritis  2/128 (1.56%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
General disorders                 
Death  101/128 (78.91%)  25/36 (69.44%)  17/20 (85.00%)  0/0  0 5/6 (83.33%)  6/9 (66.67%)  0/0  0 1/1 (100.00%)  1
Diarrhea  4/128 (3.13%)  2/36 (5.56%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Dehydration  3/128 (2.34%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Seizures  2/128 (1.56%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Hepatobiliary disorders                 
Liver failure  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Hyperbilirubinemia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Immune system disorders                 
Fever  0/128 (0.00%)  0/36 (0.00%)  1/20 (5.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Rigors  3/128 (2.34%)  2/36 (5.56%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Pneutropenic Fever  3/128 (2.34%)  2/36 (5.56%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Infections and infestations                 
Encephalopathy  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Viral encephalitis  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Fungal infection  11/128 (8.59%)  2/36 (5.56%)  2/20 (10.00%)  0/0  0 0/6 (0.00%)  1/9 (11.11%)  0/0  0 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back pain  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Avascular necrosis  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Psychiatric disorders                 
Altered mental status  1/128 (0.78%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Anorexia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Steroid-induced psychoses  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0 0/0  0 0/6 (0.00%)  0 1/9 (11.11%)  0/0  0 0/1 (0.00%)  0
Renal and urinary disorders                 
acute renal failure  1/128 (0.78%)  1/36 (2.78%)  1/20 (5.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 1/1 (100.00%) 
Kidney Stones  0/128 (0.00%)  3/36 (8.33%)  2/20 (10.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Pneumonia  5/128 (3.91%)  1/36 (2.78%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Hypoxia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Acute Respiratory Distress Syndrome (ARDS)  3/128 (2.34%)  2/36 (5.56%)  2/20 (10.00%)  0/0  0 1/6 (16.67%)  0/9 (0.00%)  0/0  0 1/1 (100.00%) 
Pulmonary Hemorrhage  2/128 (1.56%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 1/6 (16.67%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Pulmonary aspergillus  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Alveolar hemorrhage  15/128 (11.72%)  3/36 (8.33%)  2/20 (10.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Bronchopneumonia  4/128 (3.13%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Bacterial pneumonia  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Cytomegalovirus pneumonitis  3/128 (2.34%)  0/36 (0.00%)  1/20 (5.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Vascular disorders                 
Intraparenchymal Hemorrhage  1/128 (0.78%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0/9 (0.00%)  0/0  0 0/1 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) Busulfan and Cyclophosphamide (Cytoxan) BEAM Regimen Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) ATG For Cord Blood Transplants DLI (Donor Leukocyte Infusion) Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/128 (14.84%)      0/36 (0.00%)      2/20 (10.00%)      0/0      0/6 (0.00%)      0/9 (0.00%)      0/0      0/1 (0.00%)    
General disorders                 
Headache  8/128 (6.25%)  0/36 (0.00%)  2/20 (10.00%)  0/0  0 0/6 (0.00%)  0 0/9 (0.00%)  0 0/0  0 0/1 (0.00%)  0
Nausea  11/128 (8.59%)  0/36 (0.00%)  0/20 (0.00%)  0/0  0 0/6 (0.00%)  0 0/9 (0.00%)  0 0/0  0 0/1 (0.00%)  0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Maziarz
Organization: OHSU Knight Cancer Institute
Phone: 503-494-1551
EMail: maziarzr@ohsu.edu
Layout table for additonal information
Responsible Party: Richard Maziarz, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00281879     History of Changes
Other Study ID Numbers: CDR0000452794
P30CA016058 ( U.S. NIH Grant/Contract )
OHSU-TPI-9695-L
OHSU-540
First Submitted: January 24, 2006
First Posted: January 25, 2006
Results First Submitted: May 17, 2012
Results First Posted: June 19, 2012
Last Update Posted: September 27, 2017