NCT00290641

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer 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 system and help destroy any remaining cancer 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 after the transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving chemotherapy together with total-body irradiation followed by donor umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2001

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

February 9, 2006

Last Update Submit

November 27, 2017

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMyelodysplastic Syndromes

Keywords

adult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)childhood 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 syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesnoncontiguous stage II adult Burkitt lymphomarecurrent adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomarecurrent adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomarecurrent adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrefractory anemia with excess blasts in transformationrefractory cytopenia with multilineage dysplasiarecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemianoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomablastic phase chronic myelogenous leukemiachronic idiopathic myelofibrosischronic eosinophilic leukemiachronic neutrophilic leukemiacontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomastage I adult diffuse small cleaved cell lymphomacontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomacontiguous stage II grade 3 follicular lymphomastage I grade 3 follicular lymphomacontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent adult lymphoblastic lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Engraftment as measured by an absolute neutrophil count of donor origin > 0.5 x 109 /L for 3 days by day 42

Secondary Outcomes (2)

  • Incidence and severity of acute or chronic graft-versus-host-disease, relapse, or mortality at day 100

  • Survival and event-free survival by Kaplan-Meier estimation at 1 and 2 years after umbilical cord blood (UCB) transplant

Interventions

filgrastimBIOLOGICAL
graft-versus-tumor induction therapyBIOLOGICAL
cyclophosphamideDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
umbilical cord blood transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of a hematologic malignancy of 1 of the following types: * Acute myeloid leukemia (AML), meeting the following criteria: * In complete remission (CR) by morphology (\< 5% blasts in the bone marrow), as defined by 1 of the following: * In first CR (CR1) and meets ≥ 1 of the following high-risk criteria: * High-risk cytogenetics (e.g., those associated with myelodysplastic syndromes \[MDS\] or complex karotype) * Preceding MDS * More than 2 courses of therapy was required to obtain CR * In second or greater CR * No morphologic relapse * Cytogenetic relapse or persistent disease allowed * Acute lymphocytic leukemia (ALL), meeting the following criteria: * In CR, as defined by 1 of the following: * In CR1 and meets ≥ 1 of the following high-risk criteria: * Unfavorable high-risk cytogenetics \[t(9;22), t(1;19), t(4;11) or other MLL rearrangements\] * More than 1 course of therapy was required to obtain CR * In second or greater CR * No morphologic relapse or persistent disease * Chronic myelogenous leukemia (CML), excluding refractory blast crisis * Advanced myelofibrosis * Advanced myelodysplasia (blasts \< 10% \[otherwise need AML induction pre-transplant\]), meeting ≥ 1 of the following criteria: * Refractory anemia with excess blasts (RAEB) * RAEB in transformation * Refractory anemia with severe pancytopenia * High-risk cytogenetics * Non-Hodgkin's lymphoma (NHL), meeting the following criteria: * One of the following histologic subtypes: * Mantle cell NHL * Disease progression after initial therapy (e.g., CHOP) * Beyond CR1 or beyond first partial remission (PR) * Intermediate-grade NHL in second or greater CR or PR * High-grade NHL * Stage III or IV disease AND received initial therapy * Stage I or II disease at diagnosis that subsequently progressed after a prior response duration of \< 1 year * No chemotherapy-refractory NHL (i.e., \< progressive disease after \> 2 salvage regimens) * Donor available, meeting the following criteria: * No other existing HLA-identical related donor available * 4-6/6 HLA-A, -B, and -DRB1, matched unrelated donor by molecular techniques * A and B to antigen level resolution * DR to allele resolution * Umbilical cord blood (UCB) graft may consist of one or two UCB units NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Karnofsky score 80-100% (for adults) OR * Lansky score 50-100% (for children) * Creatinine ≤ 2.0 mg/dL (for adults) OR creatinine clearance \> 40 mL/min (for children) * Adults with a creatinine \> 1.2 mg/dL or a history of renal dysfunction must have a creatinine clearance \> 40 mL/min * Bilirubin ≤ 2 times normal * AST and ALT ≤ 2 times normal * Alkaline phosphatase ≤ 2 times normal * Pulmonary function \> 50 % of normal * LVEF ≥ 45% * No active infection, including Aspergillus or other mold, within the past 30 days * No history of HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior myeloablative transplant within the past 6 months if ≤ 18 years old * No prior myeloablative allotransplant or autologous transplant if \> 18 years old * No prior extensive therapy (e.g., \> 12 months of alkylating therapy or \> 6 months of alkylating therapy with extensive radiation)

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

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. doi: 10.1182/blood-2004-07-2717. Epub 2004 Oct 5.

    PMID: 15466923RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMyelodysplastic SyndromesCongenital AbnormalitiesLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseAnemia, Refractory, with Excess of BlastsBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellDendritic Cell Sarcoma, InterdigitatingLeukemia, Myeloid, AcuteLymphoma, Large-Cell, ImmunoblasticBlast CrisisPrimary MyelofibrosisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, Chronic

Interventions

FilgrastimCyclophosphamideCyclosporinefludarabine phosphateMycophenolic AcidCord Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, RefractoryAnemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidHistiocytic Disorders, MalignantHistiocytosisCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Claudio G. Brunstein, MD, PhD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 13, 2006

Study Start

April 1, 2001

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)