NCT00740467

Brief Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops 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 and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

January 28, 2010

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

August 22, 2008

Last Update Submit

January 27, 2010

Conditions

Graft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmPrecancerous Condition

Keywords

graft versus host diseaseadult acute myeloid leukemia in remissionadult 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 myeloid leukemiaadult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiaaccelerated phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiarecurrent adult Hodgkin lymphomaadult nasal type extranodal NK/T-cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell 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 adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent grade I lymphomatoid granulomatosisrecurrent grade II lymphomatoid granulomatosisrecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomasplenic marginal zone lymphomarefractory chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of graft acceptance

Interventions

anti-thymocyte globulinBIOLOGICAL
busulfanDRUG
cyclophosphamideDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of any of the following hematological cancers with a poor prognosis: * Acute myeloid leukemia meeting 1 of the following criteria: * Third complete remission (CR3) or beyond * CR2 after an early bone marrow relapse (\< 24 months) * Refractory disease after ≥ 2 chemotherapy courses of induction therapy * Acute lymphoblastic leukemia meeting 1 of the following criteria: * CR3 after ≥ 1 bone marrow relapse * CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy) * Chronic myelogenous leukemia meeting the following criteria: * Accelerated phase * Second chronic phase * No other treatment options * Multiple myeloma meeting the following criteria: * Failed conventional therapy (including autologous hematopoietic stem cell transplantation) * No other treatment alternatives * Chronic lymphocytic leukemia meeting the following criteria: * Failed conventional therapy * No other treatment alternatives * Hodgkin lymphoma meeting the following criteria: * Failed conventional therapy * No other treatment alternatives * Non-Hodgkin lymphoma meeting the following criteria: * Failed conventional therapy * No other treatment alternatives * Not eligible for standard myeloablative allograft due to increased toxicity * Healthy related donor available and meeting the following criteria: * Brother, sister, father, mother, cousin, uncle, or aunt * At least an identical HLA haplotype * Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR) * Different on ≤ 4 alleles on the other haplotype * No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Not pregnant or nursing * Fertile patients must use effective contraception * No contraindication to allogeneic transplantation, including any of the following: * Cardiac systolic ejection fraction \< 40% * DLCO level limiting use of fludarabine * Creatinine clearance \< 30 mL/min * Transaminases and/or bilirubin \> 3 times upper limit of normal (unless due to Gilbert disease or cancer) * HIV seropositivity * Human T-cell lymphotrophic virus type 1 seropositivity * Uncontrolled bacterial, viral, or fungal infection * No contraindication to any of the study drugs * No prior or concurrent psychiatric illness * No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix * No concurrent serious, uncontrolled condition * No patients deprived of liberty or subject to legal protection PRIOR CONCURRENT THERAPY: * No participation in a study of allografts in the past month

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

Sponsors & Collaborators

Study Sites (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

RECRUITING

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsCongenital AbnormalitiesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseHodgkin DiseaseLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Antilymphocyte SerumBusulfanCyclophosphamideCyclosporinefludarabine phosphateMycophenolic Acid

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellLymphadenopathyLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Didier Blaise, MD

    Institut Paoli-Calmettes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Last Updated

January 28, 2010

Record last verified: 2009-07

Locations

FR(1)