Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

NCT00593554 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 0704-19 IUCRO-0184
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation

  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.

  thru 6 months after transplant

Secondary Outcomes (6)

• Regimen-related Toxicity

  Up to 1 year

• Time to Neutrophil Engraftment

  Transplant (Day 0) up to 1 year

• Time to Platelet Engraftment

  Transplant (Day 0) up to 1 year

• Acute Graft vs. Host Disease (GvHD)

  Up to 1 year

• Chronic Graft vs. Host Disease (GvHD)

  Up to 1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Radiation: Total Body Irradiation; Drug: Thiotepa; Drug: Fludarabine; Biological: Rabbit ATG

2

EXPERIMENTAL

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Radiation: Total Body Irradiation; Drug: Thiotepa; Drug: Fludarabine; Biological: Rabbit ATG; Drug: Palifermin

Interventions

Total Body Irradiation RADIATION

8 Gy on Day -9

1; 2

Thiotepa DRUG

5 mg/kg/d on Day -8 to -7

1; 2

Fludarabine DRUG

40 mg/m2/d on Day -6 to -3

1; 2

Rabbit ATG BIOLOGICAL

2.5 mg/kg/d on Day -5 to -2

Also known as: Antithymocyte globulin, Thymoglobulin

1; 2

Palifermin DRUG

60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Also known as: Recombinant human keratinocyte growth factor, Kepivance

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherif S. Farag: lead

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Whole-Body Irradiation; Thiotepa; fludarabine; thymoglobulin; Antilymphocyte Serum; Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques; Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Dr. Sherif Farag
• Organization: IndianaU

ssfarag@iu.edu

317-278-0460

Study Officials

• Sherif Farag, MD/PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lawrence H. Einhorn Professor of Oncology

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: August 7, 2007
• Primary Completion: August 27, 2016
• Study Completion: July 28, 2017
• Last Updated: April 10, 2018
• Results First Posted: April 10, 2018

Record last verified: 2018-03

Locations

US (1)