Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

Phase 2TerminatedNCT00593554

Sherif S. Farag9 enrolled

Overview

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia

Interventions

Total Body IrradiationRADIATION

8 Gy on Day -9

ThiotepaDRUG

5 mg/kg/d on Day -8 to -7

FludarabineDRUG

40 mg/m2/d on Day -6 to -3

Rabbit ATG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria * CR 1 with poor risk features * CR 2, or higher order CR * Acute lymphoblastic leukemia (ALL) with one of the following criteria * CR 1 with poor risk features * CR 2, or higher order CR * Myelodysplasia, RAEB I * Donor has been identified * Age ≤ 65 years. * Performance Status 0-1. Exclusion Criteria: * Patients relapsing \<6 months after autologous SCT are not eligible. * Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection. * Non-pregnant and non-nursing

Locations (1)

Indiana University Cancer Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation

To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.

Time frame: thru 6 months after transplant

Secondary Outcomes

Regimen-related Toxicity

The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.

Time frame: Up to 1 year

Time to Neutrophil Engraftment

Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) \> 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.

Time frame: Transplant (Day 0) up to 1 year

Time to Platelet Engraftment

Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

Time frame: Transplant (Day 0) up to 1 year

Acute Graft vs. Host Disease (GvHD)

Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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