Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia
• Interventions: Radiation: Total Body Irradiation; Drug: Thiotepa; Drug: Fludarabine; Biological: Rabbit ATG; Drug: Palifermin

• Registration Number: NCT00593554
• Lead Sponsor: Sherif S. Farag

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-07
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2016-08-27
• Study Completion: 2017-07-28
• Status Verified: 2018-03
• Results First Submitted: 2018-03-12
• Results First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Results First Posted: 2018-04-10
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fludarabine	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
1	Rabbit ATG	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
1	Total Body Irradiation	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
2	Total Body Irradiation	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
2	Rabbit ATG	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
1	Thiotepa	Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
2	Thiotepa	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
2	Fludarabine	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
2	Palifermin	Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Primary Outcome Measures

Name	Time	Method
Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation	thru 6 months after transplant	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.

Secondary Outcome Measures

Name	Time	Method
Time to Platelet Engraftment	Transplant (Day 0) up to 1 year	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.
Regimen-related Toxicity	Up to 1 year	The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
Time to Neutrophil Engraftment	Transplant (Day 0) up to 1 year	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.
Chronic Graft vs. Host Disease (GvHD)	Up to 1 year	Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
Acute Graft vs. Host Disease (GvHD)	Up to 1 year	Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
Frequency of Infection	Day 0 through 1 year post transplantation	Number of unique patients with bacterial and/or viral infections reported.

Trial Locations

Locations (1)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States