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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02861417
Other study ID # 2016-0137
Secondary ID NCI-2017-0061420
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 5, 2016
Est. completion date August 31, 2025

Study information

Verified date December 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.


Description:

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Study Design


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Intervention

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Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-relapse mortality rate The proportion of patients with non-relapse mortality will be reported separately by arm, along with the corresponding 95% Bayesian credible interval. 100 days
Secondary Graft versus host disease-free survival/relapse free survival Will be calculated from the time of transplant by the method of Kaplan and Meier. Patients with matched donors will be compared to patients with mismatched donors by the log-rank test. Cox proportional hazards regression analysis will be used to assess the association between these survival parameters and clinical and treatment covariates of interest. Up to 3 years
Secondary Relapse-free survival Will be calculated from the time of transplant by the method of Kaplan and Meier. Patients with matched donors will be compared to patients with mismatched donors by the log-rank test. Cox proportional hazards regression analysis will be used to assess the association between these survival parameters and clinical and treatment covariates of interest. Up to 3 years
Secondary Overall survival Will be calculated from the time of transplant by the method of Kaplan and Meier. Patients with matched donors will be compared to patients with mismatched donors by the log-rank test. Cox proportional hazards regression analysis will be used to assess the association between these survival parameters and clinical and treatment covariates of interest. Up to 3 years
Secondary Non-relapse mortality The proportion of patients with non-relapse mortality will be reported separately by arm, along with the corresponding 95% Bayesian credible interval. Up to 3 years
Secondary Relapse rate Will be observed. Up to 3 years
Secondary Time to platelet and neutrophil engraftment Will be calculated from the time of transplant and estimated by the Kaplan-Meier method. Distributions will be compared between patients with matched and mismatched donors via the log-rank test. Up to 3 years
Secondary Incidence of acute and chronic graft versus host disease Will be estimated using the method of Gooley, and the method of Fine and Gray will be used to model the incidence by disease and clinical characteristics of interest, including matched versus mismatched donors. Up to 3 years
Secondary Incidence of grade 3 and 4 adverse events Descriptive statistics will be used to summarize adverse events by treatment arm. The number and proportion of subjects with treatment emergent adverse events will be reported and compared between patients with matched and mismatched donors by using Fisher's exact test. Frequency counts and percentages will also be presented of subjects with serious adverse events and adverse events leading to withdrawal. Graphical summaries will be used where appropriate. Up to 3 years
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