Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|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: NCT00544466|
Recruitment Status : Active, not recruiting
First Posted : October 16, 2007
Last Update Posted : October 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: fludarabine phosphate Drug: melphalan Procedure: allogeneic hematopoietic stem cell transplantation Radiation: intensity-modulated radiation therapy||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Treatment (enzyme inhibitor, radiation therapy, transplant)
PREPARATIVE REGIMEN*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy 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.
Drug: fludarabine phosphate
25 mg/m2 day -7 through day -3 prior to transplant
140 mg/m2 day -2 prior to transplant
Procedure: allogeneic hematopoietic stem cell transplantation
Cells infused on Day 0 of transplant regimen
Radiation: intensity-modulated radiation therapy
Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
- 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.
- 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 ]
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): NCT00544466
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Joseph Rosenthal, MD||City of Hope Medical Center|