NCT00002553

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors 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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Aug 1990

Longer than P75 for phase_2 leukemia

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

August 1, 1990

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 26, 2004

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

November 1, 1999

Last Update Submit

November 28, 2011

Conditions

LeukemiaLymphoma

Keywords

stage IV adult Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomaWaldenstrom macroglobulinemiastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiachronic 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 remissionstage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent adult non-Hodgkin 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 IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

cyclophosphamideDRUG
allogeneic bone marrow transplantationPROCEDURE
low-LET cobalt-60 gamma ray therapyRADIATION

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Hematologic malignancies of the following types: Chronic myelogenous leukemia (CML) in chronic or accelerated phase Newly diagnosed acute leukemia at high risk of relapse following chemotherapy alone Early referral encouraged so that donor search can begin as soon as possible Acute leukemia failing one cycle of induction chemotherapy Acute leukemia beyond first remission High-risk Hodgkin's disease and non-Hodgkin's lymphoma in first remission Hodgkin's disease, non-Hodgkin's lymphoma, or other malignant lymphoproliferative disease after first remission No suitable related donor available (i.e., no HLA genotypically identical sibling) No haploidentical relative with no more than 1 unshared haplotype for an HLA-A, -B, or -D locus Acute leukemia in relapse and CML in blast crisis eligible only under the following conditions: Patient's clinical condition is likely to remain stable for the 2-6 month period necessary to find a marrow donor Remission induction has been attempted Local physician and patient accept that the search or transplant may be canceled if the patient's condition deteriorates during the search No leukoencephalopathy Donor requirements: Age less than 60 In good health Phenotypically identical for HLA-A, -B, and -DRB1 1-antigen mismatch for HLA-A, -B, or -DRB1 locus allowed for patients below age 36 Patients for whom TBI is contraindicated may be treated on protocol FHCRC-739 Severe aplastic anemia should be transplanted according to protocols FHCRC-174.2 or FHCRC-800 Myelodysplastic syndrome should be transplanted according to protocol FHCRC-179.3 or FHCRC-844 PATIENT CHARACTERISTICS: Age: Under 56 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No acute hepatitis No other severe hepatic disease Renal: Creatinine less than 2 times normal for age, weight, and sex Cardiovascular: No symptomatic cardiac disease Pulmonary: No active pulmonary disease No history of pulmonary fibrosis No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70%) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60%) Other: HIV negative No severe limitations due to diseases other than malignancy PRIOR CONCURRENT THERAPY: No more than 3,000 cGy to the whole brain No more than 1,500 cGy to the chest or abdomen At least 6 months since involved-field irradiation to the chest or abdomen

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, United States

Location

Related Publications (4)

  • Anasetti C, Etzioni R, Petersdorf EW, Martin PJ, Hansen JA. Marrow transplantation from unrelated volunteer donors. Annu Rev Med. 1995;46:169-79. doi: 10.1146/annurev.med.46.1.169.

    PMID: 7598453BACKGROUND

  • Petersdorf EW, Longton GM, Anasetti C, Martin PJ, Mickelson EM, Smith AG, Hansen JA. The significance of HLA-DRB1 matching on clinical outcome after HLA-A, B, DR identical unrelated donor marrow transplantation. Blood. 1995 Aug 15;86(4):1606-13.

    PMID: 7632970RESULT

  • Beatty PG, Anasetti C, Hansen JA, Longton GM, Sanders JE, Martin PJ, Mickelson EM, Choo SY, Petersdorf EW, Pepe MS, et al. Marrow transplantation from unrelated donors for treatment of hematologic malignancies: effect of mismatching for one HLA locus. Blood. 1993 Jan 1;81(1):249-53.

    PMID: 8417795RESULT

  • Beatty PG, Hansen JA, Longton GM, Thomas ED, Sanders JE, Martin PJ, Bearman SI, Anasetti C, Petersdorf EW, Mickelson EM, et al. Marrow transplantation from HLA-matched unrelated donors for treatment of hematologic malignancies. Transplantation. 1991 Feb;51(2):443-7. doi: 10.1097/00007890-199102000-00034.

    PMID: 1994541RESULT

MeSH Terms

Conditions

LeukemiaLymphomaHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaWaldenstrom MacroglobulinemiaLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisRecurrenceLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

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

November 1, 1999

First Posted

April 26, 2004

Study Start

August 1, 1990

Study Completion

June 1, 2003

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)