NCT00008216

Brief Summary

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 1996

Longer than P75 for all trials

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

July 1, 1996

Completed
4.5 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
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

12.5 years

First QC Date

January 6, 2001

Last Update Submit

June 5, 2014

Conditions

Adult Langerhans Cell HistiocytosisChildhood Langerhans Cell HistiocytosisLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

stage IV adult Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent 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 leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionchronic myelogenous leukemia, BCR-ABL1 positivePhiladelphia chromosome negative chronic myelogenous leukemiastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin 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 lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesintraocular lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse 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 lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent mycosis fungoides/Sezary syndromejuvenile myelomonocytic leukemiachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablechronic myelomonocytic leukemiacontiguous stage II small lymphocytic lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV 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 syndromesadult Langerhans cell histiocytosis

Outcome Measures

Primary Outcomes (2)

  • Toxicity

    Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.

    6 months

  • Time to engraftment

    Days from infusion of stem cells to recovery of PMN \> 500/ul for two consecutive determinations, transfusion independence for platelets (\>20,000/ul) and RBCs (Hct \> 25%). The bone marrow function is considered durable if reconstitution persists for at least 6 months.

    6 months

Secondary Outcomes (4)

  • Clinical response

    6 months

  • Survival rate

    6 months

  • Number of participants with Graft-versus-host disease

    6 months

  • Time to treatment failure and relapse

    6 months

Study Arms (1)

alloSCT group

Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).

Procedure: Peripheral Blood Stem Cell Transplantation

Interventions

Peripheral Blood Stem Cell TransplantationPROCEDURE
alloSCT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).

DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Chronic myelogenous leukemia * Philadelphia chromosome-positive OR * Molecular evidence of bcr/abl gene rearrangement * Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia * Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities * Multiple myeloma * Hereditary immunodeficiency disorders * Confirmed by immunologic determination * Sickle cell anemia or beta-thalassemia * Confirmed by hemoglobin electrophoresis * Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy) * Confirmed by metabolic testing * Other non-malignant conditions * Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified 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 Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard bloodwork that would be required for transplantation patients

MeSH Terms

Conditions

Histiocytosis, Langerhans-CellLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL PositiveRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLeukemia, Myelomonocytic, JuvenileLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLeukemia, Myelomonocytic, ChronicLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, LymphoidLymphoma, T-CellLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteHistiocytic Disorders, MalignantLymphadenopathyLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

  • David G. Savage, MD

    Herbert Irving Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

July 1, 1996

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

US(1)