Clinical Trial: Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies

Brief Summary:

RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening.

PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.


Detailed Summary:

PRIMARY OBJECTIVES: I. To assess the feasibility in terms of toxicity and safety of HT in combination with Fludarabine (fludarabine phosphate) and Melphalan as a preparative regimen for allogeneic stem cell transplantation in patients with Hematological Malignancies: acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).

SECONDARY OBJECTIVES: I. To evaluate within the confines of this pilot study, incidence of neutrophil and platelet engraftment, survival on day +180, the overall survival, and disease free survival in patients with Hematological Malignancies: ALL, AML, and MDS.

II. To evaluate incidence of primary and secondary engraftment failure, incidence of relapse, incidence of acute and chronic transplant related complications, including veno-occlusive disease of the liver (VOD), organ toxicity, secondary malignancies, including treatment-related myelodysplastic syndrome, and acute and chronic graft-versus-host disease (GVHD), as well as post-transplant chimerism.

OUTLINE: PREPARATIVE REGIMEN*: Patients receive fludarabine phosphate intravenously (IV) on days -7 to -3 and melphalan IV on day -2. Patients also undergo HT twice daily on days -7 to -4.

TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: *Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis.

After completion of study treatment, patients are followed up periodically for 2 years.


Sponsor: City of Hope Medical Center

Current Primary Outcome: Toxicity of helical tomotherapy (HT) in combination with fludarabine and melphalan followed by allogeneic stem cell transplantation [ Time Frame: 100 days post treatment ]

Descriptive statistics will be used to summarize data outcomes. The type and grade of toxicities during therapy will be tabulated. Toxicities will be evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.


Original Primary Outcome:

  • Toxicity of helical tomotherapy (HT) in combination with fludarabine and melphalan followed by allogeneic stem cell transplantation
  • Safety


Current Secondary Outcome:

  • Incidence of neutrophil and platelet engraftment [ Time Frame: 100 days post treatment ]
  • Incidence of relapse [ Time Frame: 2 years post treatment ]
  • Incidence of acute and chronic transplant-related complications, including acute and chronic graft-vs-host disease [ Time Frame: 2 years post treatment ]
  • Secondary malignancy, including treatment-related myelodysplastic syndrome [ Time Frame: 2 years post treatment ]
  • Overall survival on day 180 days post-transplant [ Time Frame: 180 days post-transplant ]
  • Disease-free survival 180 days post-transplant [ Time Frame: 180 days post-transplant ]


Original Secondary Outcome:

  • Incidence of neutrophil and platelet engraftment
  • Incidence of relapse
  • Incidence of acute and chronic transplant-related complications, including acute and chronic graft-vs-host disease
  • Secondary malignancy, including treatment-related myelodysplastic syndrome
  • Overall survival on day 180 days post-transplant
  • Disease-free survival 180 days post-transplant


Information By: City of Hope Medical Center

Dates:
Date Received: October 13, 2007
Date Started: June 2006
Date Completion:
Last Updated: September 16, 2016
Last Verified: September 2016