Reduced Intensity Double Umbilical Cord Blood Transplantation

NCT01408563 | Completed Phase 2 Results DMC

• 1 other identifier: 11-085
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Conditions

Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia

Keywords

NHL; lymphoma; leukemia; myelodysplastic disorder; aplastic anemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Clinically Significant Infection

  The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.

  1 Year

Secondary Outcomes (12)

• Median Time to Neutrophil Engraftment

  From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days

• Median Time to Platelet Engraftment

  From the time of transplantation, until the time of platelet engraftment, median duration of 52 days

• Number of Participants With Primary Graft Failure

  From the time of transplantation until 42 days post transplantation

• Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days

  100 Days

• The Rate of Chronic GVHD

  From the time of transplantation until the time of chronic GVHD onset, up to 1 year

Study Arms (1)

Fludarabine/Melphalan/TBI

EXPERIMENTAL

All patients receive same therapy

Drug: Fludarabine; Drug: Melphalan; Radiation: Total Body Radiation; Biological: Cord Blood

Interventions

Fludarabine DRUG

30 mg/m2/day IV x 6 days

Also known as: Fludara

Fludarabine/Melphalan/TBI

Melphalan DRUG

100 mg/m2/day IV x 1 day

Fludarabine/Melphalan/TBI

Total Body Radiation RADIATION

200 cGy on Day 0

Fludarabine/Melphalan/TBI

Cord Blood BIOLOGICAL

2 cord blood units IV

Fludarabine/Melphalan/TBI

Eligibility Criteria

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

You may qualify if:

• Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
• Appropriate candidate for reduced intensity regimen, according to the treating physician
• Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
• Able to comply with the requirements for care after allogeneic stem cell transplantation

You may not qualify if:

• Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
• Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
• Renal disease
• Hepatic disease
• Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
• HIV-positive
• Uncontrolled infection
• Pregnant or breast-feeding

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Acute; Lymphoma; Leukemia; Anemia, Aplastic

Interventions

fludarabine; fludarabine phosphate; Melphalan; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Radiotherapy; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Dr. Zachariah DeFilipp
• Organization: Massachusetts General Hospital

ZDEFILIPP@mgh.harvard.edu

617-643-3944

Study Officials

• Zachariah DeFilipp, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Hematology/Oncology

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 23, 2019
• Results First Posted: November 21, 2018

Record last verified: 2018-12

Locations

US (3)