NCT00008164

Brief Summary

RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

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, 1997

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

January 1, 2007

First QC Date

January 6, 2001

Last Update Submit

December 17, 2013

Conditions

Childhood Langerhans Cell HistiocytosisLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiachildhood Langerhans cell histiocytosischronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesuntreated childhood acute lymphoblastic leukemiarecurrent/refractory childhood Hodgkin lymphomastage I adult Burkitt lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous 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 adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromechildhood chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (4)

  • Response rate

  • Toxicity

  • Survival

  • Incidence of graft-versus-host disease

Interventions

umbilical cord blood transplantationPROCEDURE

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder * Eligible for allogeneic bone marrow transplantation, but lacking a donor * Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci * HIV negative * Hepatitis B surface antigen and hepatitis C negative PATIENT CHARACTERISTICS: Age: * Under physiologic 60 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal * No severe hepatic disease * Hepatitis B surface antigen and hepatitis C negative Renal: * Creatinine less than 2 times normal Other: * HIV negative * Not pregnant or nursing * No other serious medical or psychiatric illness that would preclude study compliance * No serious infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • Styczynski J, Cheung YK, Garvin J, Savage DG, Billote GB, Harrison L, Skerrett D, Wolownik K, Wischhover C, Hawks R, Bradley MB, Del Toro G, George D, Yamashiro D, van de Ven C, Cairo MS. Outcomes of unrelated cord blood transplantation in pediatric recipients. Bone Marrow Transplant. 2004 Jul;34(2):129-36. doi: 10.1038/sj.bmt.1704537.

    PMID: 15107815RESULT

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisRecurrenceBurkitt LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, LymphoidLymphoma, T-CellLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

  • David G. Savage, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

January 1, 1997

Last Updated

December 18, 2013

Record last verified: 2007-01

Locations

US(1)