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

Browse trials for

• Leukemia, Myeloid 2,432
• Leukemia 5,475
• Leukemia, Myeloid, Acute 3,035

Leukemia, Myeloid

2,432 studies on the registry are indexed under Leukemia, Myeloid; 205 are open to participants now.

This study's enrollment of 58 is above the median of 40 across 1,968 interventional studies indexed under Leukemia, Myeloid.

Lead sponsor

Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.

Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.

Study arms

• 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: * 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

  Procedure: Allogeneic HSCT · Drug: Anti-thymocyte globulin (ATG) · Drug: Cyclosporine (CSP) · Drug: Mycophenolate mofetil (MMF) · Radiation: Total lymphoid irradiation (TLI) · Drug: Methylprednisolone sodium succinate

• 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: * 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

  Drug: Best standard care

Interventions

• ProcedureAllogeneic 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.

  Also known as: Hematopoietic stem cell transplantation (HSCT), Peripheral blood stem cell (PBSC) transplantation

• DrugAnti-thymocyte globulin (ATG)

  1.5 mg/kg for 5 days by IV

  Also known as: Thymoglobulin, Anti-thymocyte globulin (rabbit) (ATG)

• DrugCyclosporine (CSP)

  6.25 mg/kg twice daily oral

  Also known as: Ciclosporin, cyclosporin A, cyclosporin

• DrugMycophenolate mofetil (MMF)

  15 mg/kg twice daily oral

  Also known as: Cellcept

• RadiationTotal lymphoid irradiation (TLI)

  80 cGy/fraction radiotherapy in 10 fractions.

• DrugMethylprednisolone sodium succinate

  1.0 mg/kg for 5 days by IV

  Also known as: Solumedrol, Medrol, Depo-Medrol, P-Care D40, P-Care D80

• DrugBest 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

  Also known as: Standard of Care (physician discretion), Regular medical care

Primary outcomes

1. Overall Survival (OS)

   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

Secondary outcomes

1. Disease-free Survival (DFS)

   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

2. Non-relapse Mortality

   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

3. Relapse Rate

   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

4. Transplant-related Mortality

   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

5. Complete Donor Hematopoietic Cell Chimerism

   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

6. Early Graft Loss

   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

7. Patients Completing the Intended Therapy in Both Arms

   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

Baseline characteristics

Individual participant data

Plan to share: No