Total Marrow and Lymphoid Irradiation

Phase II Study of Evaluating the Efficacy of Total Marrow and Lymphoid Irradiation (TMLI) as the Conditioning Regimen for HLA-Haploidentical Hematopoietic Cell Transplantation in Patients With Myelodysplasia or Acute Leukemia

What's the purpose of the trial?

This phase II trial studies how well total marrow and lymphoid irradiation works as a conditioning regimen before hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can lower the relapse rate but has some fatal side effects such as irreversible damage to normal internal organs and graft-versus-host disease (a complication after transplantation in which donor's immune cells recognize the host as foreign and attack the recipient's tissues). Total body irradiation is a form of radiotherapy that involves irradiating the patient's entire body in an attempt to suppress the immune system, prevent rejection of the transplanted bone marrow and/or stem cells and to wipe out any remaining cancer cells. Intensity-modulated radiation therapy (IMRT) is a more recently developed method of delivering radiation. Total marrow and lymphoid irradiation is a method of using IMRT to direct radiation to the bone marrow. Total marrow and lymphoid irradiation may allow a greater dose of radiation to be delivered to the bone marrow as a preparative regimen before hematopoietic cell transplant while causing less side effects to normal organs than standard total body irradiation.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
70
Last Updated
1 month ago
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Participating Centers

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Experimental Treatments

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  • Allogeneic Stem Cell Transplant is a type of stem cell transplant that utilizes a donor's pre-collected stem cells to rescue the bone marrow from the toxic effects of very high dose chemotherapy.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Granulocyte Colony-Stimulating Factor is a glycoprotein used to stimulate the bone marrow to help with granulocyte and stem cell production.
  • Mycophenolate Mofetil is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.

Arms / Cohorts

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Accepting patients

Fludarabine +TMLI + HCT + Cyclophosphamide

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