Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00593554
• Other study ID #: 0704-19 IUCRO-0184
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2008
• Last updated: March 12, 2018
• Start date: August 7, 2007
• Est. completion date: July 28, 2017

Study information

• Verified date: March 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 28, 2017
• Est. primary completion date: August 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplasia
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Radiation:
• Total Body Irradiation
8 Gy on Day -9

Drug:
• Thiotepa
5 mg/kg/d on Day -8 to -7
• Fludarabine
40 mg/m2/d on Day -6 to -3

Biological:
• Rabbit ATG
2.5 mg/kg/d on Day -5 to -2

Drug:
• Palifermin
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Sherif S. Farag

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	thru 6 months after transplant
Secondary	Regimen-related Toxicity	The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.	Up to 1 year
Secondary	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.	Transplant (Day 0) up to 1 year
Secondary	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.	Transplant (Day 0) up to 1 year
Secondary	Acute Graft vs. Host Disease (GvHD)	Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.	Up to 1 year
Secondary	Chronic Graft vs. Host Disease (GvHD)	Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.	Up to 1 year
Secondary	Frequency of Infection	Number of unique patients with bacterial and/or viral infections reported.	Day 0 through 1 year post transplantation