Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

NCT01622556 | Terminated Phase 2 DMC

• 1 other identifier: 15954 UCB-2011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.

Conditions

Hematologic Malignancies

Keywords

Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkins Lymphoma; Hodgkin's Disease; Myelodysplastic Syndromes; Myeloproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Number of subjects surviving with no events at 180 days post transplantation (Day 0).

  180 days

Secondary Outcomes (7)

• Transplant Engraftment

  Day 42

• Incidence of Graft-versus-host disease (GVHD)

  1 year

• Time course for peripheral blood chimerism.

  56 days

• Incidence of secondary lymphoproliferative diseases

  6 months

• Incidence of disease recurrence

  Up to two years

Study Arms (1)

Reduced Intensity Conditioning with UCB Transplant

EXPERIMENTAL

Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Radiation: Total Body Irradiation; Biological: Umbilical Cord Blood

Interventions

Fludarabine DRUG

35 mg/m2 IV/day x 5 days

Reduced Intensity Conditioning with UCB Transplant

Busulfan DRUG

.8 mg/kg IV Q6h x 8 doses

Reduced Intensity Conditioning with UCB Transplant

Thymoglobulin DRUG

1.5 mg/kg/day x 3 days

Reduced Intensity Conditioning with UCB Transplant

Total Body Irradiation RADIATION

150 cGy for 2 days

Reduced Intensity Conditioning with UCB Transplant

Umbilical Cord Blood BIOLOGICAL

Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.

Reduced Intensity Conditioning with UCB Transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18-70 years old. ECOG 0-2
• Patients must have a diagnosis of one of the following:
• Chronic Myeloid Leukemia
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Hodgkin's Disease
• Non-Hodgkins Lymphoma
• Myelodysplastic Syndromes
• Myeloproliferative Disorder
• Patients must have adequate visceral organ function
• Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
• Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.

You may not qualify if:

• Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
• Patients who are pregnant are ineligible.
• Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
• Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Myelodysplastic Syndromes; Myeloproliferative Disorders

Interventions

fludarabine; Busulfan; thymoglobulin; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Amer M Beitinjaneh, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 19, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2017
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (1)