NCT00005804

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Typical duration for phase_2

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

October 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 28, 2003

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

2.8 years

First QC Date

June 2, 2000

Last Update Submit

March 31, 2010

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous/Nonmalignant ConditionSmall Intestine Cancer

Keywords

monoclonal gammopathy of undetermined significancerecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaBurkitt lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomaWaldenstrom macroglobulinemiastage 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 leukemiasmall intestine lymphomachildhood immunoblastic large cell lymphomachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase 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 remissionpolycythemia verachronic idiopathic myelofibrosisessential thrombocythemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiarecurrent/refractory childhood Hodgkin lymphomachronic myelomonocytic leukemiaT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiastage III adult lymphoblastic lymphomastage IV adult lymphoblastic 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 lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprolymphocytic leukemiaprimary systemic amyloidosisintraocular lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

cyclophosphamideDRUG
allogeneic bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically proven hematologic malignancy of 1 of the following types: * Chronic myelogenous leukemia (CML) in chronic, accelerated, or blast\* phase * Acute leukemia with high-risk features at diagnosis such as: * Philadelphia chromosome-positive acute lymphocytic leukemia\*\* * Acute myeloid leukemia with high-risk cytogenetics such as inv (3), t(3;3) del(5q), -5, del(7q), -7, +8, +11, abnormal 12p, del(20q), -20, or complex abnormalities\*\* * Acute leukemia with failure after one course of induction chemotherapy * Acute leukemia in first relapse\* or second remission * High-risk lymphoblastic lymphoma in first remission * Non-Hodgkin's lymphoma, Hodgkin's disease, or other malignant lymphoproliferative disease after first remission, if an autologous transplantation is not indicated * Myelodysplastic or myeloproliferative syndromes ineligible for Protocol FHCRC-179 NOTE: \* For patients with acute leukemia in relapse or CML in blast crisis, the search for an unrelated donor begins only if: High probability that the patient's medical condition will remain stable for the 3 to 6-month period needed to find a donorAn attempt at remission induction has been undertaken Referring physician and patient accept possibility that search for donor will be canceled if patient's condition worsens NOTE: \*\* For newly diagnosed patients with high-risk acute leukemia, early referral is encouraged so that an unrelated donor search may begin immediately * Availability of an unrelated donor with: * 1 HLA-A or B non-cross-reactive group (non-CREG) mismatch (except in CML in chronic phase or myelodysplastic syndrome) OR * 1 HLA-A or B CREG mismatch OR * An HLA-A, B, and C match with an HLA-DRB1 or DQB1 mismatch (no double mismatch) if 1 of the above 2 donor types unavailable * No more than 1 HLA-A, B, and C mismatch * No availability of an HLA-identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A or B locus of the nonshared haplotypes * For patients with diagnosis other than CML in chronic phase, 1 HLA-DR locus-incompatible related donor has priority over an HLA compatible or class IA or B CREG locus antigen-incompatible unrelated donor * No severe aplastic anemia * No leukoencephalopathy PATIENT CHARACTERISTICS: Age: * Under 51 * Eligible for transplantation until age 52 if the donor is identified prior to patient's 51st birthday Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * No severe hepatic disease, including acute hepatitis Renal: * Creatinine less than 2 times normal Cardiovascular: * No cardiac insufficiency requiring treatment * No symptomatic coronary artery disease Pulmonary: * No severe hypoxemia (i.e., PO2 less than 70 mm Hg) with decreased DLCO (i.e., DLCO less than 70% predicted) OR * No mild hypoxemia (i.e., PO2 less than 80 mm Hg) with severely decreased DLCO (i.e., DLCO less than 60% predicted) * No pulmonary fibrosis Other: * No other nonmalignant disease that would severely limit life expectancy * HIV negative * No contraindication to total body irradiation (TBI) * Patients excluded from this study because of contraindication to TBI may be treated on protocol FHCRC-739 PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy greater than 3,000 cGy to whole brain * At least 6 months since prior involved-field radiotherapy greater than 1,500 cGy to chest or abdomen 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)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsMonoclonal Gammopathy of Undetermined SignificancePrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousBurkitt LymphomaWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialLeukemia, Hairy CellRecurrenceLeukemia, Myelomonocytic, ChronicLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticImmunoglobulin Light-chain AmyloidosisIntraocular LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CyclophosphamideRadiotherapy

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaLeukemia, LymphoidLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersMyelodysplastic-Myeloproliferative DiseasesLeukemia, T-CellAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesEye NeoplasmsHistiocytic Disorders, MalignantHistiocytosisLymphadenopathyLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTherapeutics

Study Officials

  • Claudio Anasetti, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

August 28, 2003

Study Start

October 1, 1999

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)