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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT00593554
Recruitment Status : Terminated (Slow accrual)
First Posted : January 15, 2008
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 9 participants
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
Actual Study Start Date : August 7, 2007
Actual Primary Completion Date : August 27, 2016
Actual Study Completion Date : July 28, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation [ Time Frame: thru 6 months after transplant ]
    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. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.


Secondary Outcome Measures :
  1. Regimen-related Toxicity [ Time Frame: Up to 1 year ]
    The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.

  2. Time to Neutrophil Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.

  3. Time to Platelet Engraftment [ Time Frame: Transplant (Day 0) up to 1 year ]
    Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

  4. Acute Graft vs. Host Disease (GvHD) [ Time Frame: Up to 1 year ]
    Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.

  5. Chronic Graft vs. Host Disease (GvHD) [ Time Frame: Up to 1 year ]
    Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.

  6. Frequency of Infection [ Time Frame: Day 0 through 1 year post transplantation ]
    Number of unique patients with bacterial and/or viral infections reported.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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 Posted: January 15, 2008    Key Record Dates
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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