Intraosseous Infusion of Unrelated Cord Blood Grafts

NCT00967525 | Terminated DMC

• 2 other identifiers: IRB00000113Intraosseous Infusion
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

In this trial the investigators seek to determine if injecting cord blood cells directly into the bone marrow (intraosseous injection), rather than infusing them intravenously, can improve engraftment. The rational for doing this is that most hematopoietic stem cells (HSCs) infused intravenously never reach the bone marrow, getting trapped by other organs, such as the lungs, instead. The potential advantage of intraosseous infusion is suggested by studies in rodents that have demonstrated that in HSC transplants where the cell dose is limiting intraosseous injection is a more effective route of administration. The safety of intraosseous injections, in general, is underscored by the vast experience using intraosseous injections for resuscitation of critically ill children. The safety of injecting HSCs intraosseously has been demonstrated in a clinical trial of transplanting bone marrow cells. To safeguard against problems that might result, if intraosseous infusion fails to improve engraftment in this trial, the investigators will integrate a recently introduced strategy proven to improve engraftment-the transplantation of two cord blood units. Transplanting two unrelated cord blood units by intravenous infusion has been shown to improve engraftment (although there is still room for improvement). In this trial one unit will be injected intraosseously and the other unit will be infused intravenously. This study is being conducted as a forerunner to a larger, multi-center trial. The investigators intend to enroll five patients over 1-2 years.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

AML; ALL; leukemia; CML; Myelodysplastic Syndrome; malignancies; Undifferentiated leukemia; High risk malignancies

Outcome Measures

Primary Outcomes (1)

• Compare the rapidity of myeloid engraftment of intraosseously and intravenously administered unrelated cord blood grafts.

  1 year after last patient enrolled

Secondary Outcomes (1)

• Obtain preliminary data using flow cytometric analysis to assess the importance of graft associated variables that may affect engraftment.

  1 year after last patient enrolled

Study Arms (1)

1

EXPERIMENTAL

Receive two cord blood units. One administered by intraosseous infusion and the other by intravenous infusion. The second unit is being given as a safeguard, but will also allow the researchers to directly compare engraftment between intravenously and intraosseously infused cord blood units.

Procedure: cord blood infusion

Interventions

cord blood infusion PROCEDURE

Receive two cord blood units. One administered by intraosseous infusion and the other by intravenous infusion. The second unit is being given as a safeguard, but will also allow the researchers to directly compare engraftment between intravenously and intraosseously infused cord blood units.

1

Eligibility Criteria

• Age: 36 Months - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 36 months to 60 years old (YO)
• No prior autologous or allogeneic transplant
• Karnofsky performance score or Lansky Play-Performance of at least 80

You may not qualify if:

• Age \< 36 months or \> 60 YO
• creatinine clearance or nuclear medicine GFR of \< 50 mL/min
• cardiac ejection fraction \< 50%
• bilirubin \> 2 × upper limit of normal or ALT \> 4 × upper limit of normal or unresolved veno-occlusive disease
• Pulmonary carbon monoxide diffusing capacity (DLCO), adjusted for Hgb \< 50%
• Karnofsky performance score or Lansky Play-Performance Scale \<80
• Uncontrolled viral, bacterial, or fungal infection at the time of study enrollment
• Seropositive for HIV
• Availability of a willing and well HLA matched related (genotypically identical or mismatched at a single allele or antigen defined by typing at HLA A, B, C and DRB1 loci) donor
• Availability of a willing and well HLA matched unrelated (allele matched or mismatched at a single allele defined by allele level typing for HLA A, B, C and DRB1 loci) adult blood or marrow donor
• Availability of an umbilical cord blood unit, which provides at least a 4/6 HLA match as defined above and ≥ 5.0 \* 107 NC/Kg (cryopreserved)

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Leukemia; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• John Horan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 28, 2009
• Study Start: March 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (2)