Completed

Donor Lymphocyte Infusion (DLI) as Adoptive Immunotherapy for Relapse Malignancies After Allogeneic Hematopoietic Transplantation

What is being tested

peripheral blood lymphocyte therapy

Biological

Who is being recruted

Urogenital Diseases+115

+ Genital Diseases

+ Adnexal Diseases

From 1 to 70 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: August 1998

See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center

Last updated: November 30, 2011

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1998

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Offer donor lymphocyte infusion as adoptive immunotherapy in patients with relapsed malignancies after allogeneic bone marrow or peripheral blood stem cell transplantation and who are not eligible for other FHCRC protocols. OUTLINE: Patients with rapidly progressive disease receive reinduction chemotherapy and radiotherapy prior to study therapy. Donor lymphocyte infusions (DLI) begin after recovery from chemotherapy or sooner, if clinically indicated. Patients receive 1 or more DLI from the original donor. Patients are followed monthly for 3 months, then every 3-6 months for 9 months. PROJECTED ACCRUAL: An unlimited number of patients will be accrued for this study.

NCT00003887

Principal SponsorFred Hutchinson Cancer Center

Last updated: November 30, 2011

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesBlood Protein DisordersBone Marrow DiseasesBreast DiseasesCarcinomaCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsKidney DiseasesLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMesonephromaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic ProcessesNeoplastic Syndromes, HereditaryOvarian DiseasesParaproteinemiasPathologic ProcessesPregnancy ComplicationsPregnancy Complications, NeoplasticSkin DiseasesPathological Conditions, Signs and SymptomsTesticular DiseasesTrophoblastic NeoplasmsTumor Virus InfectionsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellLymphoma, T-CellSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, Complex and MixedNeoplasms, Connective and Soft TissueGerminomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesCarcinogenesisCarcinoma, Ovarian EpithelialBlast CrisisBreast NeoplasmsBurkitt LymphomaHodgkin DiseaseKidney NeoplasmsLeukemiaLeukemia, Hairy CellLymphomaLymphoma, FollicularLymphoma, Non-HodgkinMultiple MyelomaMycosis FungoidesMyelodysplastic SyndromesMyeloproliferative DisordersWilms TumorNeuroblastomaOvarian NeoplasmsRecurrenceSarcomaSezary SyndromeTeratomaTesticular NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousCarcinoma, EmbryonalSeminomaEndodermal Sinus TumorLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellGestational Trophoblastic DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellDendritic Cell Sarcoma, InterdigitatingPrimary Myelofibrosis

Criteria

DISEASE CHARACTERISTICS: Diagnosis of relapsed malignancy after allogeneic transplantation Rapidly progressive malignancies (acute leukemias) should receive induction chemotherapy or radiotherapy prior to this study Persistent donor cells Must be able to tolerate a taper of steroids to a dosage of no greater than 0.25 mg/kg/day and be off all other immunosuppressive therapy for 2 weeks without significant flare of graft vs host disease (GVHD) No grade II-IV acute GVHD or extensive chronic GVHD Same donor as for prior transplant PATIENT CHARACTERISTICS: Age: 1 to 70 Performance status: Karnofsky 30-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics At least 1 week since immunosuppressive therapy for advanced malignancy At least 2 weeks since immunosuppressive therapy for nonadvanced malignancy Radiotherapy: See Disease Characteristics Surgery: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fred Hutchinson Cancer Research Center

Seattle, United StatesOpen Fred Hutchinson Cancer Research Center in Google Maps

CompletedOne Study Center