NCT00959231

Brief Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor umbilical cord blood transplant after cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with hematologic disease.

Trial Health

55
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

August 26, 2013

Status Verified

April 1, 2010

Enrollment Period

3.6 years

First QC Date

August 13, 2009

Last Update Submit

August 23, 2013

Conditions

Hematopoietic/Lymphoid Cancer

Keywords

hematopoietic/lymphoid cancer

Outcome Measures

Primary Outcomes (1)

  • Non-relapse mortality at day 100

Secondary Outcomes (3)

  • Incidence of grades II-IV and III-IV acute graft-vs-host disease (GVHD) at day 100 and chronic GVHD at 1 year

  • Mixed chimerism

  • Hemopoietic recovery

Interventions

cyclophosphamideDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
laboratory biomarker analysisOTHER
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE
umbilical cord blood transplantationPROCEDURE
total-body irradiationRADIATION

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of high-risk, advanced or poorly responding hematological disease for which a reduced-intensity hemopoietic stem cell transplantation is likely to be effective * Disease status is such that there is no alternative therapy likely to achieve a cure or provide a significant prolongation of disease-free survival * No chronic myelogenous leukemia in first chronic phase responding to imatinib or refractory blast crisis * No acute leukemia in morphological relapse/persistent disease (defined as \> 5% blasts in normocellular bone marrow) * No malignant disease that is refractory to or progressive on salvage therapy * No myelofibrosis * Donor must be matched at HLA-A and -B at antigen level and HLA-DRB1 at allelic level * No available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor OR 10/10 unrelated volunteer donor PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100% (pediatrics) * Transaminases \< 5 times upper limit of normal (ULN) * Bilirubin \< 3 times ULN * Creatinine clearance \> 50 mL/min * DLCO \> 50% predicted * No supplemental oxygen requirements * Not pregnant or nursing * Negative pregnancy test * No HIV or HTLV (I and II) antibody positivity or evidence of infection * No acquired aplastic anemia * No decompensated congestive heart failure or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 35% * No current active serious infection, in particular uncontrolled fungal infection * No congenital immune deficiencies PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 6 months since prior exposure to combination chemotherapy OR only 1 course of induction combination chemotherapy for myelodysplastic syndromes or acute myeloid leukemia (please discuss with study coordinator/s if this course contained fludarabine) * At least 6 months since prior myeloablative bone marrow transplantation * No prior irradiation that precludes the safe administration of an additional dose of 200 cGy of total-body irradiation * No prior autograft

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

RECRUITING

Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, LS16 6QB, United Kingdom

RECRUITING

University College of London Hospitals

London, England, NW1 2PQ, United Kingdom

RECRUITING

UCL Cancer Institute

London, England, WC1E 6DD, United Kingdom

RECRUITING

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

RECRUITING

University of Newcastle-Upon-Tyne Northern Institute for Cancer Research

Newcastle upon Tyne, England, NE2 4HH, United Kingdom

RECRUITING

Related Publications (1)

  • Hough R, Lopes A, Patrick P, Russell N, Raj K, Tholouli E, A Snowden J, Collin M, El-Mehidi N, Lawrie A, Clifton-Hadley L, Veys P, Craddock C, Mackinnon S, Cook G, Shaw B, Marks D. Primary graft failure, but not relapse, may be identified by early chimerism following double cord blood unit transplantation. Blood Adv. 2022 Apr 12;6(7):2414-2426. doi: 10.1182/bloodadvances.2021005106.

    PMID: 34700343DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

CyclophosphamideCyclosporinefludarabine phosphateMycophenolic AcidCord Blood Stem Cell TransplantationWhole-Body Irradiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeRadiotherapyInvestigative Techniques

Study Officials

  • Rachael Hough, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2012

Last Updated

August 26, 2013

Record last verified: 2010-04

Locations

GB(6)