Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

University of Oklahoma17 enrolled

Overview

To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Primary Endpoints: 1. Engraftment of donor cells 2. Regimen related toxicities Secondary Endpoints: 1. Disease-free survival 2. Overall survival

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematological Neoplasms Hematopoietic Stem Cell Transplantation

Interventions

Busulfex, Fludarabine, ALemtuzumabDRUG

Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Performance status 0-2 * Ejection fraction \> 30% * AST/ALT and bilirubin not \> 4 times normal * Creatinine clearance greater than 70 ml/min. * FEV1 greater than 1.0 and diffusion capacity greater than 40% * Age 18-75 years * Patients must be at high risk for conventional regimen related toxicity * Malignant hematologic disease that would otherwise be considered treatable with ASCT Exclusion Criteria: * Does not meet the above Inclusion criteria

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Number of Participants Experiencing Transplant Related Mortality (TRM)

Time frame: At Day 100 post trans-plant

Number of Participants Experiencing Engraftment Donor Chimerism (EDC)

Time frame: At time of study termination

Secondary Outcomes

Number of Participants Relapse-Free

Time frame: 100 days post-transplant

Number of Participants Overall Survival as a Function of Time.

Time frame: 100 days post transplant

Data from ClinicalTrials.gov

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