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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

This study is currently recruiting participants.
Verified May 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00593554
First received: January 4, 2008
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  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
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:

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 ]
  • Describe the frequency and type of infections occurring within the first year following transplantation. [ Time Frame: Day 0 through 1 year post transplantation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Describe the rate of progression-free survival and overall survival [ Time Frame: Baseline until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: December 2007
Estimated Primary Completion Date: December 2015 (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: Indiana University
ClinicalTrials.gov Identifier: NCT00593554     History of Changes
Other Study ID Numbers: 0704-19 IUCRO-0184
Study First Received: January 4, 2008
Last Updated: May 9, 2013
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 May 16, 2013