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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593554
First Posted: January 15, 2008
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Sherif S. Farag, 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Actual Study Start Date: August 7, 2007
Study Completion Date: May 5, 2016
Primary Completion Date: May 5, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593554


Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Sherif S. Farag
Investigators
Principal Investigator: Sherif Farag, MD/PhD Indiana University School of Medicine
  More Information

Responsible Party: Sherif S. Farag, Lawrence H. Einhorn Professor of Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT00593554     History of Changes
Other Study ID Numbers: 0704-19 IUCRO-0184
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine
Fludarabine phosphate
Thiotepa
Thymoglobulin
Antilymphocyte Serum
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs