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Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

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: NCT00568633
Recruitment Status : Terminated (Poor accrual)
First Posted : December 6, 2007
Results First Posted : September 11, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Robert Lowsky, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Myeloid
Leukemia
Acute Myeloid Leukemia (AML)
Interventions Procedure: Allogeneic HSCT
Drug: Anti-thymocyte globulin (ATG)
Drug: Cyclosporine (CSP)
Drug: Mycophenolate mofetil (MMF)
Radiation: Total lymphoid irradiation (TLI)
Drug: Methylprednisolone sodium succinate
Drug: Best standard care
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Period Title: Overall Study
Started 25 33
Completed 25 33
Not Completed 0 0
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care Total
Hide Arm/Group Description

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Total of all reporting groups
Overall Number of Baseline Participants 25 33 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 33 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  80.0%
26
  78.8%
46
  79.3%
>=65 years
5
  20.0%
7
  21.2%
12
  20.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 33 participants 58 participants
60  (5.1) 60  (6) 60  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 33 participants 58 participants
Female
11
  44.0%
11
  33.3%
22
  37.9%
Male
14
  56.0%
22
  66.7%
36
  62.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 33 participants 58 participants
Hispanic or Latino
0
   0.0%
3
   9.1%
3
   5.2%
Not Hispanic or Latino
25
 100.0%
30
  90.9%
55
  94.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 33 participants 58 participants
American Indian or Alaska Native
0
   0.0%
1
   3.0%
1
   1.7%
Asian
2
   8.0%
5
  15.2%
7
  12.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   6.1%
2
   3.4%
Black or African American
0
   0.0%
2
   6.1%
2
   3.4%
White
22
  88.0%
21
  63.6%
43
  74.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.0%
2
   6.1%
3
   5.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 33 participants 58 participants
25 33 58
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 33
Measure Type: Count of Participants
Unit of Measure: Participants
9
  36.0%
13
  39.4%
2.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 33
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.0%
9
  27.3%
3.Secondary Outcome
Title Non-relapse Mortality
Hide Description Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 33
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
2
   6.1%
4.Secondary Outcome
Title Relapse Rate
Hide Description Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 33
Measure Type: Count of Participants
Unit of Measure: Participants
20
  80.0%
24
  72.7%
5.Secondary Outcome
Title Transplant-related Mortality
Hide Description Transplant-related mortality will be assessed as any death occurring within 6 months post-transplant, from any cause except relapse. It will be measured at 100 day and 6 months after transplant. The outcome is expressed as at the number of participants experiencing transplant-related mortality (a number without dispersion).
Time Frame 100 days and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 0
Measure Type: Count of Participants
Unit of Measure: Participants
At 100 days
0
   0.0%
At 6 months
1
   4.0%
6.Secondary Outcome
Title Complete Donor Hematopoietic Cell Chimerism
Hide Description Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 0
Measure Type: Number
Unit of Measure: percentage of participants
56
7.Secondary Outcome
Title Early Graft Loss
Hide Description Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Best Standard Care arm did not receive transplant, and are not evaluable for transplant outcomes.
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 0
Measure Type: Number
Unit of Measure: percentage of participants
4
8.Secondary Outcome
Title Patients Completing the Intended Therapy in Both Arms
Hide Description The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
Hide Arm/Group Description:

Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
Overall Number of Participants Analyzed 25 33
Measure Type: Number
Unit of Measure: percentage of participants
100 81.8
Time Frame 2 years
Adverse Event Reporting Description Non-serious adverse events were not collected in this study.
 
Arm/Group Title Allo-HSCT + TLI + ATG Best Standard Care
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Participants achieving complete remission after consolidation therapy & who have 5 of 6 HLA-match sibling donor to provide PBSC harvest for transplant. Pre-transplant subjects receive:

  • Total lymphoid radiation (TLI) Days -11 to -7, and Days -4 to -1 (2 fractions on day -1)
  • Anti-thymocyte globulin (ATG) Days -11 to -7
  • Methylprednisolone Days -11 to -7
  • Cyclosporine (CSP) Days -4 to +2
  • 5+ of 6 HLA-matched CD34+ cells on Day 0
  • Mycophenolate mofetil (MMF), Day 0 to Day +28

Allogeneic HSCT: Allogeneic, 5+ of 6 HLA-matched PBSC transplant from sibling, mobilized to target of 5 x 10e6 CD34+ cells/kg and < 7 x 10e8 CD3+ cells/kg.

Anti-thymocyte globulin (ATG): 1.5 mg/kg for 5 days by IV

Cyclosporine (CSP): 6.25 mg/kg twice daily oral

Mycophenolate mofetil (MMF): 15 mg/kg twice daily oral

Total lymphoid irradiation (TLI): 80 cGy/fraction radiotherapy in 10 fractions.

Methylprednisolone sodium succinate: 1.0 mg/kg for 5 days by IV

Regular medical care for participants who achieve complete remission after standard consolidation therapy, but do not have a 5 of 6 HLA-match sibling donor. Treatment may consist of:

  • Additional consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation

Best standard care: Intervention consist of:

  • Consolidation chemotherapy (3-4 cycles of cytarabine +/- an anthracycline agent, or other consolidation)
  • Autologous transplantation
  • Non-Myeloablative unrelated-donor transplant, +/- TLI and ATG conditioning
  • Umbilical cord blood transplantation
  • Haploidentical transplantation
All-Cause Mortality
Allo-HSCT + TLI + ATG Best Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   16/25 (64.00%)      20/33 (60.61%)    
Hide Serious Adverse Events
Allo-HSCT + TLI + ATG Best Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/25 (80.00%)      24/33 (72.73%)    
General disorders     
Death not otherwise specified *  1/25 (4.00%)  1 1/33 (3.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Relapse, leukemia   20/25 (80.00%)  20 24/33 (72.73%)  24
Nervous system disorders     
Altered mental status *  1/25 (4.00%)  1 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allo-HSCT + TLI + ATG Best Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/33 (0.00%)    
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
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Name/Title: Robert Lowsky, Professor of Medicine (Blood and Marrow Transplantation)
Organization: Stanford University
Phone: 650-725-8950
EMail: rlowsky@stanford.edu
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Responsible Party: Robert Lowsky, Stanford University
ClinicalTrials.gov Identifier: NCT00568633    
Other Study ID Numbers: IRB-05567
97843 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT190 ( Other Identifier: OnCore )
First Submitted: December 4, 2007
First Posted: December 6, 2007
Results First Submitted: August 16, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 24, 2019