NCT00068523

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening. PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

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

June 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

September 10, 2003

Last Update Submit

July 23, 2020

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

refractory multiple myelomaaccelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionblastic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarefractory chronic lymphocytic leukemiarelapsing chronic myelogenous leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromesrecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarefractory anemia with excess blasts in transformationrefractory anemia with excess blastssecondary myelodysplastic syndromesPhiladelphia chromosome negative chronic myelogenous leukemiachronic idiopathic myelofibrosisB-cell chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiachronic phase chronic myelogenous leukemiarecurrent adult Hodgkin lymphomarecurrent adult T-cell leukemia/lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromesecondary acute myeloid leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablerecurrent marginal zone lymphomarecurrent small lymphocytic 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)

Outcome Measures

Primary Outcomes (1)

  • Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.

    Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.

Interventions

anti-thymocyte globulinBIOLOGICAL

anti-thymocyte globulin IV over 4 hours on days -2 to -1

cyclophosphamideDRUG

cyclophosphamide IV over 1 hour on days -3 to -2

cyclosporineDRUG

oral cyclosporine on days -1 to 100

fludarabine phosphateDRUG

fludarabine IV over 30 minutes on days -8 to -4

methylprednisoloneDRUG

methylprednisolone (oral or IV) on days 5-15

UV light therapyPROCEDURE

Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.

allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of any of the following hematologic malignancies: * Acute myeloid leukemia (AML) meeting any of the following criteria: * First complete remission with high-risk karyotype * Translocations t(15;17) allowed only if failed first-line induction therapy OR molecular evidence of persistent disease exists * Translocations t(8;21) and inv(16) allowed only if failed first-line induction therapy * Second or subsequent complete remission * Minimal residual disease\* * Acute lymphoblastic leukemia meeting any of the following criteria: * Failed induction therapy and has minimal residual disease\* by salvage therapy * First complete remission with high-risk karyotype (e.g., t\[4;11\] or t\[9;22\]) * Relapsed disease allowed provided a second or subsequent complete remission or minimal residual disease\* is achieved * Chronic myelogenous leukemia meeting any of the following criteria: * Persistent or relapsed disease after 1 year of imatinib mesylate therapy * Accelerated phase or blast crisis * Blast crisis allowed after reinduction chemotherapy places disease in chronic phase * Myelodysplastic syndromes meeting any of the following criteria: * Refractory to medical management * Cytogenetic abnormalities predictive of transformation into acute leukemia, including 5q-, 7q-, monosomy 7 and trisomy 8, or evidence of evolution to AML (e.g., refractory anemia with excess blasts (RAEB) or RAEB in transformation) * Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria: * Beyond first complete remission or failed primary induction therapy and demonstrated sensitivity to therapy during the 6 months before transplantation * Recurrent disease after autologous stem cell transplantation * Must be at least 3 months posttransplantation * Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission * Multiple myeloma meeting either of the following criteria: * Refractory or relapsed disease * Residual disease after autologous transplantation * Chronic lymphocytic leukemia (CLL) meeting all of the following criteria: * Peripheral blood absolute lymphocyte count greater than 5,000/mm\^3 * Small to moderate size lymphocytes and less than 55% pro-lymphocytes, atypical lymphocytes, or lymphoblasts morphologically * B-cell or T-cell * Myeloproliferative disorders, including myelofibrosis * Philadelphia negative * Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR genetically matched unrelated donor * Must meet 1 of the following criteria: * At least 55 years of age at time of transplantation * Received extensive prior therapy (i.e., more than 1 year of alkylator therapy or more than 2 different prior salvage regimens) or stem cell transplantation with myeloablative conditioning (either autologous or allogeneic) * Presenting with comorbid condition (e.g., abnormal cardiac, pulmonary, or renal function and/or prior life-threatening infection) that precludes eligibility for enrollment in allogeneic transplantation protocols with full ablation conditioning * No active CNS disease NOTE: \*Defined as having no circulating blasts, absolute neutrophil count greater than 1,000/mm3 and less than 10% blasts in bone marrow at least 3 weeks after last systemic chemotherapy PATIENT CHARACTERISTICS: Age * See Disease Characteristics * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * See Disease Characteristics Hepatic * Bilirubin no greater than 2.0 mg/dL * ALT/AST no greater than 4 times normal Renal * See Disease Characteristics * Creatinine less than 2.0 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * See Disease Characteristics * Normal cardiac function by echocardiogram or radionuclide scan * Shortening fraction or ejection fraction at least 40% of normal Pulmonary * See Disease Characteristics * DLCO at least 60% * FEV\_1 greater than 50% of predicted * Pulse oximetry greater than 85% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No uncontrolled active infection PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 2 weeks since prior biologic response modifiers, signal transduction inhibitors, or monoclonal antibodies Chemotherapy * See Disease Characteristics * At least 4 weeks since prior systemic conventional chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Recovered from prior therapy * No concurrent sun block/sunscreen or any cosmetic that may act as a sunscreen (e.g., lotion with SPF) on the days of scheduled ultraviolet-B light therapy

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticLymphoma, FollicularLymphoma, Mantle-CellAnemia, Refractory, with Excess of BlastsPrimary MyelofibrosisLeukemia, Large Granular LymphocyticLeukemia, Myeloid, Chronic-PhaseHodgkin DiseasePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLymphoma, B-Cell, Marginal ZoneCongenital Abnormalities

Interventions

Antilymphocyte SerumCyclophosphamideCyclosporinefludarabine phosphateMethylprednisoloneUltraviolet TherapyPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLeukemia, B-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsAnemia, RefractoryAnemiaLeukemia, T-CellLymphoma, T-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPhototherapyTherapeuticsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • Omer N. Koc, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

June 1, 2003

Primary Completion

March 1, 2004

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

US(1)