NCT00295880

Brief Summary

Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor's umbilical cord blood are injected into the patient's bone marrow they may help make stem cells, red blood cells, white blood cells, and platelets. Purpose: This phase I/II trial is studying the side effects of donor umbilical cord blood transplant when given directly into the bone marrow and to see how well it works in treating patients with hematologic cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 3, 2009

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

February 23, 2006

Results QC Date

March 25, 2009

Last Update Submit

December 3, 2017

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMyelodysplastic Syndromes

Keywords

adult acute myeloid leukemia in remissionadult acute myeloid leukemiachildhood acute myeloid leukemia in remissionsecondary acute myeloid leukemiaaccelerated phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarefractory anemia with excess blastsde novo myelodysplastic syndromesmyelodysplastic syndromesadult diffuse large cell lymphomaadult diffuse mixed cell lymphomaadult diffuse small cleaved cell lymphomaadult lymphoblastic lymphomagrade 3 follicular lymphomamantle cell lymphomachildhood large cell lymphomachildhood lymphoblastic lymphomaadult acute lymphoblastic leukemiaacute lymphoblastic leukemiarefractory anemiarefractory cytopeniachildhood acute myeloid leukemiaadult immunoblastic large cell lymphomablastic phase chronic myelogenous leukemiachronic eosinophilic leukemiachronic neutrophilic leukemiachildhood small noncleaved cell lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Median Number of Days to Neutrophil Engraftment

    Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.

    Daily through Day 60 post transplant

Secondary Outcomes (7)

  • Number of Patients Achieving Neutrophil Recovery

    6 months

  • Number of Patients With Evidence of Engraftment.

    1 year

  • Number of Patients With Acute Graft-versus-host Disease (GVHD)

    100 days post transplant

  • Number of Patients With Transplant-related Mortality (TRM)

    Day 100 and Day 180

  • Number of Patients Surviving at Day 100 and 1 Year.

    Day 100 and 1 year

  • +2 more secondary outcomes

Study Arms (1)

Transplant Patients

EXPERIMENTAL

Patients receiving umbilical cord blood transplantation.

Procedure: umbilical cord blood transplantation

Interventions

umbilical cord blood transplantationPROCEDURE

The graft will be given by slow injection into each posterior iliac crest.

Also known as: UCBT
Transplant Patients

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Acute myeloid leukemia (AML): high risk CR1
  • Acute lymphocytic leukemia (ALL): high risk CR1 \[t(9;22), t (1:19), t(4;11) or other MLL rearrangements\] or \> 1 cycle to obtain CR; CR2+. All patients must be in CR as defined by hematological recovery, AND \<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
  • Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
  • Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics.
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm).
  • Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.
  • Large cell NHL \> CR2/\> PR2. Patients in CR2/PR2 with initial short remission (\<6 months) are eligible.
  • Lymphoblastic lymphoma.
  • Multiple myeloma beyond PR2.
  • Karnofsky performance status (PS) 90-100% (adults)
  • Lansky PS 50-100% (children)
  • Acceptable organ function

You may not qualify if:

  • Active infection at time of transplantation
  • History of HIV infection
  • Pregnant or breast feeding.
  • Chemotherapy refractory large cell and high grade NHL (ie progressive disease after \> 2 salvage regimens)
  • Extensive prior therapy including \> 12 months alkylator therapy or \> 6 months alkylator therapy with extensive radiation.
  • Diffuse myelofibrosis of BM (bone marrow) (any severity) regardless of primary diagnosis (focal fibrosis acceptable provided it involves \< 20% of BM volume).
  • History of pelvic irradiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Brunstein CG, Barker JN, Weisdorf DJ, Defor TE, McKenna D, Chong SY, Miller JS, McGlave PB, Wagner JE. Intra-BM injection to enhance engraftment after myeloablative umbilical cord blood transplantation with two partially HLA-matched units. Bone Marrow Transplant. 2009 Jun;43(12):935-40. doi: 10.1038/bmt.2008.417. Epub 2009 Jan 12.

    PMID: 19139736RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMyelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseAnemia, Refractory, with Excess of BlastsLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellDendritic Cell Sarcoma, InterdigitatingAnemia, RefractoryCytopeniaLymphoma, Large-Cell, ImmunoblasticBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicBurkitt Lymphoma

Interventions

Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemiaLymphoma, B-CellLeukemia, LymphoidHistiocytic Disorders, MalignantHistiocytosisCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Limitations and Caveats

This study was terminated early based on interim statistical analysis that indicated time to engraftment will not be improved compared to historical controls. While safe, lack of faster marrow recovery supports early discontinuation.

Results Point of Contact

Title
John E. Wagner, M.D.
Organization
Masonic Cancer Center, University of Minnesota Blood and Marrow Transplant Program
wagne002@umn.edu
612-626-2961

Study Officials

  • John E. Wagner, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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

February 23, 2006

First Posted

February 24, 2006

Study Start

June 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 28, 2017

Results First Posted

September 3, 2009

Record last verified: 2017-12