NCT00627666

Brief Summary

RATIONALE: Giving chemotherapy before a donor bone marrow stem cell transplant helps stop the growth of cancer cells. Chemotherapy and antithymocyte globulin 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving donor stem cell transplant together with busulfan, fludarabine, and antithymocyte globulin works in treating patients with hematological cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jan 2003

Typical duration 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

January 1, 2003

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 26, 2013

Status Verified

July 1, 2009

Enrollment Period

7.4 years

First QC Date

February 29, 2008

Last Update Submit

March 25, 2013

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

adult acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiaacute lymphocytic leukemiasecondary acute myeloid leukemiaacute undifferentiated leukemiamast cell leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiachronic myelomonocytic leukemiaadult 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)de novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablerefractory anemia with excess blasts in transformationrefractory anemia with excess blasts

Outcome Measures

Primary Outcomes (2)

  • Treatment-related mortality

  • Engraftment

Secondary Outcomes (6)

  • Regimen-related toxicities

  • Graft-versus-host-disease

  • Relapse

  • Overall survival

  • Failure-free survival

  • +1 more secondary outcomes

Interventions

anti-thymocyte globulinBIOLOGICAL
busulfanDRUG
fludarabine phosphateDRUG
leucovorin calciumDRUG
methotrexateDRUG
allogeneic bone marrow transplantationPROCEDURE
allogeneic hematopoietic stem cell transplantationPROCEDURE
nonmyeloablative allogeneic hematopoietic stem cell transplantationPROCEDURE

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of any 1 of the following: * Acute leukemia * Chronic myelogenous leukemia * Myelodysplastic syndromes * Must have an unrelated donor available who is matched for HLA-A and -B by serology and for DRB1 by molecular typing PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 3.0 mg/dL * Creatinine \< 2.0 mg/dL * AST and ALT \< 3 times the upper limit of normal * Not pregnant or nursing * Ejection fraction ≥ 45% by MUGA scan or ECHO * No major illness or organ failure * No severe psychiatric disorder or mental deficiency that makes compliance with the treatment unlikely and informed consent impossible PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Lee KH, Choi SJ, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Yun SC, Joo YD, Lee WS, Kang MJ, Kim H, Park JH, Bae SH, Ryoo HM, Kim MK, Hyun MS. Clinical effect of reduced-intensity conditioning regimen containing antithymocyte globulin for hematopoietic cell transplantation from unrelated-donors. Am J Hematol. 2011 May;86(5):399-405. doi: 10.1002/ajh.21989.

    PMID: 21523798RESULT

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelomonocytic, ChronicCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersAnemia, Refractory, with Excess of Blasts

Interventions

Antilymphocyte SerumBusulfanfludarabine phosphateLeucovorinMethotrexate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, RefractoryAnemia

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesAminopterin

Study Officials

  • Kyoo H. Lee, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 3, 2008

Study Start

January 1, 2003

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 26, 2013

Record last verified: 2009-07

Locations

KR(1)