Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers

NCT00539656 | Terminated Phase 1 Results

• 3 other identifiers: J0606NA_00001903M052663
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety of transplantation of two cord blood products, including toxicities in patients following high-dose, myeloablative chemotherapy for blood malignancies. It is also to determine if the use of two cord products results in an improvement in neutrophil engraftment.

Conditions

Acute Myeloid Leukemia; Leukemia, Lymphoblastic, Acute; Leukemia, Bilineage, Acute; Leukemia, Myeloid, Chronic

Keywords

Cord blood stem cell transplantation; Ex vivo expansion; Alternative donor

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Toxicities Related to Infusion of Expanded Cord Blood Products

  7 days

• Neutrophil Engraftment Within 21 Days

  Number of participants who reached 3 consecutive days with ANC \> 500

  21 days

Secondary Outcomes (1)

• Non-relapse Mortality

  100 days

Study Arms (1)

Receive two cord blood units

EXPERIMENTAL

One cord blood unit will be thawed on day -14 before transplantation and selected using the CliniMACS for primitive cells that express CD133. These cells will be expanded ex vivo for a total of 14 days, using a two-stage procedure. On Day 0 the expanded cells will be harvested, washed three times with CliniMACS buffer (Miltenyi) plus 1% HSA per standard laboratory and clinical practice and the expanded cell product will be infused to a patient who has been prepared with a standard, myeloablative preparative regimen. A second, unexpanded, cord blood product will be infused on Day +1 for safety.

Biological: Ex vivo expansion of cord blood

Interventions

Ex vivo expansion of cord blood BIOLOGICAL

Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused

Also known as: Miltenyi CliniMACS CD133

Receive two cord blood units

Eligibility Criteria

• Age: 6 Months - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient must have two cord units available. Units must be minimally matched to the subject at 4/6 antigens (HLA Class I (A or B) and Class II (DRB1) - units must have at lease one HLA DRB1 matched allele) and at least one unit must contain a minimum of 1.0 x 107 Total Nucleated Cells /Kg but neither unit may have \> 5 x 107Total Nucleated Cells /Kg. (The feasibility of using particular units will be discussed with the Principal Investigators)
• Disease status precludes waiting to identify a suitably HLA matched unrelated donor
• Patients must have a diagnosis of one of the following:
• AML
• refractory AML
• Secondary AML
• ALL in CR2 with high-risk features such as short CR1 and/or high-risk cytogenetics
• ALL in CR1 following initial induction failure
• Acute mixed lineage leukemia
• CML beyond chronic phase 1.
• Lymphoma (Hodgkins or Non-Hodgkins) ineligible for Autologous-BMT
• Myelodysplastic Syndrome
• Able to provide informed consent or parent/guardian able to provide informed consent.

You may not qualify if:

• Consenting 5/6 or 6/6 HLA matched related donor available
• Single cord blood product with cell count \>5 x10E7 Total Nucleated Cells/kg
• Poor Performance Status: ECOG performance status \>= 2 (Karnofsky or Lansky Play performance\<70).
• Poor Cardiac Function (obtained within 3 weeks of the start of transplant): Left ventricular ejection fraction \<= 45% as determined by MUGA or ECHO. For pediatric patients LVEF \< 45 % or a Shortening Fraction below normal limits for age.
• Poor Pulmonary Function (obtained within 3 weeks of the start of transplant):
• FEV1 and FVC \<50% of predicted for patients who have not received thoracic or mantle irradiation.
• For patients who have received thoracic or mantle irradiation, FEV1 and FVC \<= 75% of predicted or DLCO \<= 50% of predicted
• For children unable to perform PFTs second to developmental stage, Pulse oximetry \<= 85% on RA
• Poor Liver Function (obtained within 1 week of the start of transplant): Bilirubin \>= 2.0 mg/dl. (with the exception of patients whose hyperbilirubinemia is the result of Gilbert's disease)
• Poor Renal Function (obtained within 3 weeks of the start of transplant): Corrected CrCl \< 60 mg/min. CrCl will be estimated by the Schwartz formula. A measured CrCl or a GFR may be substituted to determine the subject's CrCl
• HIV Infection: Patients who are HIV positive. (The role of allogenic transplant in HIV+ individuals has not been studied)
• Pregnancy: Patients who are pregnant. (The chemotherapeutic agents used in bone marrow transplant are teratogenic)
• Uncontrolled viral, bacterial or fungal infections
• Patients with symptoms consistent with RSV, influenza A, B or parainfluenza at the time of enrollment on this study will be assayed for the above viruses and if positive are not eligible for the trial until are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms second to the nature of the assay)
• Presence of concomitant medication or incident condition that would create an unreasonable risk for the subject to participate in this study as determined by the investigators (Primary or co-investigators).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Children's Cancer Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; 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

Results Point of Contact

• Title: Allen Chen, MD,PhD,MHS
• Organization: Johns Hopkins University School of Medicine

chenal@jhmi.edu

410-614-4434

Study Officials

• Allen R. Chen, MD,PhD. MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Study Start: December 20, 2007
• Primary Completion: October 20, 2009
• Study Completion: October 20, 2009
• Last Updated: February 18, 2020
• Results First Posted: April 3, 2019

Record last verified: 2020-02

Locations

US (1)