NCT00255684

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, 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 transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor umbilical cord blood transplant for hematologic cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
26 days until next milestone

Results Posted

Study results publicly available

June 27, 2016

Completed
Last Updated

November 3, 2016

Status Verified

September 1, 2016

Enrollment Period

9.3 years

First QC Date

November 18, 2005

Results QC Date

May 18, 2016

Last Update Submit

September 28, 2016

Conditions

Chronic Myeloproliferative DisordersGraft Versus Host DiseaseLeukemiaLymphomaMultiple MyelomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

graft versus host diseaseadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiachildhood acute myeloid leukemia in remissionrecurrent childhood acute myeloid leukemiaadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remissionrecurrent childhood acute lymphoblastic leukemiaacute undifferentiated leukemiaaccelerated phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiarefractory anemia with excess blastsrefractory anemiachronic myelomonocytic leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativejuvenile myelomonocytic leukemiaprimary myelofibrosisrefractory hairy cell leukemiastage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomarefractory chronic lymphocytic leukemiastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)de novo myelodysplastic syndromesrecurrent mycosis fungoides/Sezary syndromerecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent mantle cell lymphomarelapsing chronic myelogenous leukemiamyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromesrecurrent adult Hodgkin lymphomasecondary acute myeloid leukemiasecondary myelodysplastic syndromesnoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Survived 100 Days or Longer

    100 days

Secondary Outcomes (1)

  • Number of Participants Who Developed Acute Graft Versus Host Disease

    3 months

Study Arms (1)

Conditioning therapy followed by TBI

EXPERIMENTAL

Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil

Biological: graft-versus-tumor induction therapyDrug: cyclophosphamideDrug: cyclosporineDrug: fludarabine phosphateDrug: mycophenolate mofetilProcedure: umbilical cord blood transplantationRadiation: radiation therapy

Interventions

graft-versus-tumor induction therapyBIOLOGICAL
Conditioning therapy followed by TBI
cyclophosphamideDRUG
Conditioning therapy followed by TBI
cyclosporineDRUG
Conditioning therapy followed by TBI
fludarabine phosphateDRUG
Conditioning therapy followed by TBI
mycophenolate mofetilDRUG
Conditioning therapy followed by TBI
umbilical cord blood transplantationPROCEDURE
Conditioning therapy followed by TBI
radiation therapyRADIATION
Conditioning therapy followed by TBI

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Acute myeloid leukemia (AML) with or without history of myelodysplastic syndromes, meeting 1 of the following criteria: * In first complete remission (CR-1) with unfavorable cytogenetics and/or achieved CR-1 after ≥ 1 course of induction therapy * Secondary or treatment-related AML * In second or further complete remission * Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * In CR-1 with unfavorable cytogenetics or elevated WBC at presentation OR failed to achieve CR-1 after ≥ 4 weeks of induction therapy * In second or further complete remission * Relapsed with ≤ 20% blasts in the bone marrow AND no circulating blasts * Other acute leukemic variants allowed at the discretion of the principal investigator * Chronic myelogenous leukemia (CML), meeting 1 of the following criteria: * In first chronic phase AND refractory to or unable to tolerate imatinib mesylate * In second or further chronic phase * In first or second accelerated phase * Myelodysplastic syndromes with intermediate 2- or high-risk International Prognosis Scoring System (IPSS) score, including any of the following: * Refractory anemia * Refractory anemia with excess blasts * Chronic myelomonocytic leukemia * Myeloproliferative disorders with poor prognosis, including any of the following: * Myelofibrosis with myeloid metaplasia * No ≥ grade 3 myelofibrosis * Atypical CML * Juvenile myelomonocytic leukemia * Other clonal hemopathies with an accepted poor prognosis * Multiple myeloma with chromosome 13 abnormalities and/or progression after prior autologous bone marrow transplantation (BMT) * Chronic lymphocytic leukemia, meeting 1 of the following criteria: * Primary refractory OR relapsed and refractory disease (less than partial remission) * Relapsed twice on or after prior chemotherapy * Lymphoma, meeting both of the following criteria: * Hodgkin's or non-Hodgkin's lymphoma in \> CR-1 OR failed primary induction * Chemosensitive disease, defined as \> 50% reduction in mass size after the most recent chemotherapy * Must meet ≥ 1 of the following criteria: * Over 45 years of age * Has undergone prior autologous or allogeneic BMT * Charlson\^ comorbidity score ≥ 2 * Must have a high degree of tumor control (salvage therapy allowed) * At high risk for treatment-related mortality with a myeloablative conditioning regimen * No massive splenomegaly * Patients may become eligible after splenectomy or radiotherapy to the spleen * No 5/6 or 6/6 HLA-matched related donor available * No well-matched (i.e., ≥ 9/10 HLA match by high-resolution typing) unrelated donor available PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * Transaminases ≤ 4 times ULN (unless due to underlying disease) Renal * Creatinine clearance ≥ 50 mL/min Cardiovascular * Ejection fraction ≥ 30% Pulmonary * DCLO ≥ 35% Other * Negative pregnancy test * No uncontrolled viral, bacterial, or fungal infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Other * At least 3 months since prior immunosuppressive therapy * At least 10 days since prior salvage therapy for patients not in at least morphologic or radiologic complete remission

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

Sponsors & Collaborators

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, AcuteLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseAnemia, Refractory, with Excess of BlastsAnemia, RefractoryLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Myelomonocytic, JuvenilePrimary MyelofibrosisLeukemia, Hairy CellLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseaseRecurrenceBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousDendritic Cell Sarcoma, Interdigitating

Interventions

CyclophosphamideCyclosporinefludarabine phosphateMycophenolic AcidCord Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemiaLeukemia, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, T-CellHistiocytic Disorders, MalignantHistiocytosis

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, Operative

Results Point of Contact

Title
Gordon L. Phillips
Organization
Wake Forest
gophilli@wakehealth.edu
604.875.4111

Study Officials

  • Gordon L. Phillips, MD

    James P. Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

December 1, 2003

Primary Completion

March 1, 2013

Study Completion

June 1, 2016

Last Updated

November 3, 2016

Results First Posted

June 27, 2016

Record last verified: 2016-09

Locations

US(1)