Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia	Radiation: Total Body Irradiation Drug: Thiotepa Drug: Fludarabine Biological: Rabbit ATG Drug: Palifermin	Phase II

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

ChemIDplus related topics:

Thiotepa Fludarabine Fludarabine monophosphate Palifermin Fibroblast growth factor 7

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Indiana University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Describe regimen-related toxicity [ Time Frame: baseline through end of treatment ] [ Designated as safety issue: Yes ]
Describe the time to engraftment of neutrophils and platelets following haplotype-mismatched CD34 selected cells [ Time Frame: baseline through end of study ] [ Designated as safety issue: No ]
Assess the risks of acute and chronic GvHD following infusion of highly purified CD34 cells [ Time Frame: baseline through end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	46
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;	Radiation: Total Body Irradiation 8 Gy on Day -9 Drug: Thiotepa 5 mg/kg/d on Day -8 to -7 Drug: Fludarabine 40 mg/m2/d on Day -6 to -3 Biological: Rabbit ATG 2.5 mg/kg/d on Day -5 to -2
2: Experimental Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG	Radiation: Total Body Irradiation 8 Gy on Day -9 Drug: Thiotepa 5 mg/kg/d on Day -8 to -7 Drug: 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593554

Contacts


Contact: Lisa Wood, RN	317-274-1781	llwood@iupui.edu

Contact: Sherif Farag, MD	317-274-0843	ssfarag@iupui.edu

Locations


United States, Indiana
	Indiana University Cancer Center	Recruiting
	Indianapolis, Indiana, United States, 46202
	Contact: Lisa Wood, RN 317-274-1781 llwood@iupui.edu
	Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu

Sponsors and Collaborators

Indiana University

Investigators


Principal Investigator:	Sherif Farag, MD/PhD	Indiana University School of Medicine

More Information

IU Simon Cancer Center "Find a Clinical Trial" This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University School of Medicine ( Sherif Farag, MD, PhD/ Principal Investigator )
Study ID Numbers:	0704-19 IUCRO-0184
First Received:	January 4, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00593554
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neural Tube Defects

Leukemia, Lymphoid

Hematologic Neoplasms

Precancerous Conditions

Chronic myelogenous leukemia

Nervous System Malformations

Leukemia, Myeloid, Acute

Leukemia

Preleukemia

Congenital Abnormalities

Lymphoma

Acute myelocytic leukemia

Myelodysplastic syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders

Hematologic Diseases

Myelodysplastic Syndromes

Myelodysplasia

Myeloproliferative Disorders

Acute myelogenous leukemia

Fludarabine monophosphate

Leukemia, Myeloid

Thiotepa

Antilymphocyte Serum

Lymphatic Diseases

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neural tube defect, folate-sensitive

Fludarabine

Lymphoproliferative Disorders

Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00593554