Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00593554
First received: January 4, 2008
Last updated: September 17, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
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
Antilymphocyte Serum
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014