Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML
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|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
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid Leukemia Acute Myeloid Leukemia (AML)||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||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Treatment assignment was based on availability of an HLA-matched donor.|
|Masking:||None (Open Label)|
|Official Title:||A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission|
|Actual Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 31, 2015|
|Actual Study Completion Date :||December 31, 2015|
Experimental: Allo-HSCT + TLI + ATG
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:
Procedure: 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.
Drug: Anti-thymocyte globulin (ATG)
1.5 mg/kg for 5 days by IV
Drug: Cyclosporine (CSP)
6.25 mg/kg twice daily oral
Drug: Mycophenolate mofetil (MMF)
15 mg/kg twice daily oral
Other Name: Cellcept
Radiation: Total lymphoid irradiation (TLI)
80 cGy/fraction radiotherapy in 10 fractions.
Drug: Methylprednisolone sodium succinate
1.0 mg/kg for 5 days by IV
Active Comparator: Best Standard Care
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:
Drug: Best standard care
Intervention consist of:
- Overall Survival (OS) [ Time Frame: 2 years ]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).
- Disease-free Survival (DFS) [ Time Frame: 2 years ]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).
- Non-relapse Mortality [ Time Frame: 2 years ]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).
- Relapse Rate [ Time Frame: 2 years ]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).
- Transplant-related Mortality [ Time Frame: 100 days and 6 months ]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).
- Complete Donor Hematopoietic Cell Chimerism [ Time Frame: 2 years ]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.
- Early Graft Loss [ Time Frame: 2 years ]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.
- Patients Completing the Intended Therapy in Both Arms [ Time Frame: 2 years ]The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568633
|United States, California|
|Kaiser Permanente Northern California|
|Hayward, California, United States, 94545|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Univeristy of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, West Virginia|
|West Virginia University Hospital|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Robert Lowsky||Stanford University|