Overview

This trial is active, not recruiting.

Conditions acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplasia, chronic myeloid leukemia
Treatments total body irradiation, thiotepa, fludarabine, rabbit atg, palifermin
Phase phase 2
Sponsor Sherif S. Farag
Start date December 2007
End date December 2016
Trial size 9 participants
Trial identifier NCT00593554, 0704-19 IUCRO-0184

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
total body irradiation
8 Gy on Day -9
thiotepa
5 mg/kg/d on Day -8 to -7
fludarabine
40 mg/m2/d on Day -6 to -3
rabbit atg Antithymocyte globulin
2.5 mg/kg/d on Day -5 to -2
(Experimental)
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
total body irradiation
8 Gy on Day -9
thiotepa
5 mg/kg/d on Day -8 to -7
fludarabine
40 mg/m2/d on Day -6 to -3
rabbit atg Antithymocyte globulin
2.5 mg/kg/d on Day -5 to -2
palifermin Recombinant human keratinocyte growth factor
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Primary Outcomes

Measure
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.
time frame: thru 6 months after transplant

Secondary Outcomes

Measure
Describe regimen-related toxicity
time frame: baseline through end of treatment
Describe the time to engraftment of neutrophils and platelets following haplotype-mismatched CD34 selected cells
time frame: baseline through end of study
Assess the risks of acute and chronic GvHD following infusion of highly purified CD34 cells
time frame: baseline through end of study
Describe the frequency and type of infections occurring within the first year following transplantation.
time frame: Day 0 through 1 year post transplantation
Describe and gather preliminary data on thymic immune reconstitution following transplantation in patients receiving and not receiving KGF.
time frame: Day -11, -10 and -9 pre transplant
Explore the correlation between KIR-ligand mismatching and KIR gene mismatching between donor and recipient and outcome, including relapse rate, event-free survival, and overall survival.
time frame: Baseline until death
Describe the rate of progression-free survival and overall survival
time frame: Baseline until death

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
Principal investigator Sherif Farag, MD/PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Indiana University.