NCT00800150

Brief Summary

RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.

Trial Health

57
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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

November 27, 2008

Last Update Submit

June 3, 2015

Conditions

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

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaadult grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomasplenic marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III mycosis fungoides/Sezary syndromestage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage IV mycosis fungoides/Sezary syndromestage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaintraocular lymphomaprimary central nervous system non-Hodgkin lymphomaprimary myelofibrosisstage II multiple myelomastage III multiple myelomarefractory multiple myelomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablecutaneous B-cell non-Hodgkin lymphomaWaldenstrom macroglobulinemia

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy

  • Toxicity

Secondary Outcomes (6)

  • Frequency of clinical response

  • Frequency of primary and secondary engraftment failure

  • Time to neutrophil and platelet engraftment

  • Incidence of acute and chronic graft-versus-host disease

  • Overall survival

  • +1 more secondary outcomes

Interventions

fludarabine phosphateDRUG
melphalanDRUG
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE
intensity-modulated radiation therapyRADIATION
tomotherapyRADIATION
total marrow irradiationRADIATION
total nodal irradiationRADIATION

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histopathologically confirmed diagnosis of 1 of the following: * Acute myeloid leukemia (AML) * Myelodysplastic syndromes * Intermediate- or high-risk disease * Myelofibrosis * Granulocytic sarcoma (chloroma) * With or without bone marrow involvement * Mixed lineage leukemia * Induction therapy must have been directed predominantly against AML * Acute lymphoblastic leukemia * Non-Hodgkin lymphoma * Multiple myeloma * Relapsed or refractory disease with M3 marrow (marrow blasts \> 25%), meeting 1 of the following criteria: * Persistent disease after an induction attempt * Persistent initial disease after two induction attempts * Relapse after one re-induction attempt (second relapse) * Persistent disease after first relapse and initial re-induction attempt * Not eligible for myeloablative allogeneic hematopoietic stem cell transplantation due to age (\> 50 years), organ insufficiency, or significant comorbidity * Patients 16-50 years of age must meet ≥ 1 of the following criteria: * Ejection fraction 50-60% by MUGA scan and/or echocardiogram * DLCO 50-75% of predicted * Creatinine clearance or GFR 60-80 mL/min * Serum bilirubin ≤ 2.0 mg/dL * SGOT and SGPT 1.5-5 times upper limit of normal * No other medical and/or psychosocial problem that, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from study regimen * No Fanconi anemia * HLA-identical sibling OR matched unrelated donor available PATIENT CHARACTERISTICS: * Zubrod or Karnofsky performance status 70-100% * Negative pregnancy test * Able to lie supine in a full body cast for 30 minutes * No HIV infection * No evidence of active hepatitis B or C infection * No evidence of cirrhosis * No uncontrolled viral, bacterial, or fungal infection within the past 4 weeks * No radiographic changes indicating pulmonary disease (e.g., pulmonary nodules, infiltrates, or pleural effusion) unless cleared by pulmonary biopsy that shows no evidence of active pulmonary disease * No major medical or psychiatric disorder that would seriously compromise patient tolerance of study regimen PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiation 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)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcutePrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellIntraocular LymphomaPrimary MyelofibrosisWaldenstrom Macroglobulinemia

Interventions

fludarabine phosphateMelphalanRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, LymphoidLeukemia, MyeloidLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEye NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Joseph Rosenthal, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2008

First Posted

December 1, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)