NCT00014469

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_2

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

December 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

6.4 years

First QC Date

April 10, 2001

Last Update Submit

March 6, 2013

Conditions

Graft Versus Host DiseaseLeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiaacute undifferentiated leukemiasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesgraft versus host diseaserefractory cytopenia with multilineage dysplasiajuvenile myelomonocytic leukemiachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiableadult 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)

Interventions

busulfanDRUG
melphalanDRUG
methotrexateDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Infant leukemia * Acute lymphoblastic leukemia in 3rd or greater remission or relapse * Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse * Juvenile chronic myelogenous leukemia (CML) * Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse * Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts * Therapy-related MDS of any stage or AML * CML in 2nd or greater chronic phase, accelerated, or blastic phase * Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI) due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2 years of age) * No active CNS disease * Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1 PATIENT CHARACTERISTICS: Age: * Under 60 (over 60 considered on case-by-case basis) Performance status: * Karnofsky 70-100% * Lansky 70-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * AST and ALT less than 2 times upper limit of normal * Bilirubin less than 1.5 mg/dL unless liver is involved with disease Renal: * Creatinine normal * Creatinine clearance greater than 60 mL/min Cardiovascular: * Asymptomatic with no prior risk factors OR * LVEF greater than 50% if symptomatic Pulmonary: * Asymptomatic with no prior risk factors OR * Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic Other: * No active uncontrolled viral, bacterial, or fungal infection * Not pregnant or nursing * Negative pregnancy test * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 6 months since prior allogeneic or autologous stem cell transplantation Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * 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)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Graft vs Host DiseaseLeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLeukemia, Biphenotypic, AcuteLeukemia, Myelomonocytic, JuvenileLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

BusulfanMelphalanMethotrexateTacrolimus

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersLeukemia, MyeloidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemia, RefractoryAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesLactones

Study Officials

  • Trudy N. Small, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)