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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Leukemia Myelodysplastic Syndromes

Drug Information available for: Thiotepa Fludarabine Fludarabine monophosphate Palifermin

U.S. FDA Resources

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 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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 Other Names: Antithymocyte globulin Thymoglobulin
Experimental: 2 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 Other Names: Antithymocyte globulin Thymoglobulin Drug: Palifermin 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 Other Names: Recombinant human keratinocyte growth factor Kepivance

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	317-944-1781	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 317-944-1781 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

Additional Information:

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

No publications provided

Responsible Party:	Sherif Farag, MD, PhD/ Principal Investigator, Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00593554 History of Changes
Other Study ID Numbers:	0704-19 IUCRO-0184
Study First Received:	January 4, 2008
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
Antilymphocyte Serum
Thiotepa
Fludarabine monophosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 13, 2012