NCT00134017

Brief Summary

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5.7 years

First QC Date

August 22, 2005

Results QC Date

July 31, 2018

Last Update Submit

August 29, 2018

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

adult acute myeloid leukemia in remissionrefractory anemia with excess blastsadult 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)childhood acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiasecondary acute myeloid leukemiade novo myelodysplastic syndromesadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiachronic eosinophilic leukemiachronic idiopathic myelofibrosischronic neutrophilic leukemiastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage II multiple myelomastage III multiple myelomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomapreviously treated myelodysplastic syndromesrecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent adult Hodgkin lymphomarecurrent small lymphocytic lymphomarecurrent marginal zone 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 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 III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomachronic myelomonocytic leukemiarefractory chronic lymphocytic leukemiarefractory multiple myelomasecondary myelodysplastic syndromesstage IV adult lymphoblastic lymphomachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)

    Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).

    Day 100

Secondary Outcomes (4)

  • Days to Engraftment

    Up to one year

  • Chimerism

    Day 30, Day 60

  • Non-relapse Mortality

    Day 100, 2 years

  • Relapse

    2 years

Study Arms (1)

Bone marrow transplant

EXPERIMENTAL

Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis

Drug: BusulfanDrug: Cyclophosphamide

Interventions

BusulfanDRUG

Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m\^2 daily (for pediatric recipients)

Also known as: Myleran, Busulfex
Bone marrow transplant
CyclophosphamideDRUG

Days -3, -2, +3, +4: 50 mg/kg IV daily

Also known as: Cytoxan, CTX
Bone marrow transplant

Eligibility Criteria

Age6 Months - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * AML beyond first complete remission (CR1) * Refractory AML * AML arising from myelodysplastic syndromes (MDS) * Secondary AML * MDS * Refractory anemia with excess blasts with \> 10% blasts in bone marrow * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * ALL in CR1 with 1 of the following high-risk features: * Philadelphia chromosome (Ph)-positive disease * Less than 1 year of age at diagnosis * Cytogenetic abnormalities involving chromosome 11q23 * ALL beyond CR1 * Refractory ALL * Chronic myeloid leukemia beyond first chronic phase * Chronic myelomonocytic leukemia * Chronic lymphocytic leukemia * Stage III-IV disease * Does not meet criteria for other bone marrow transplantation (BMT) studies * Myeloproliferative disorders * Ph-negative disease * Hodgkin's or non-Hodgkin's lymphoma * Chemotherapy-resistant disease * Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis * Multiple myeloma * Stage II or III disease * Very high-risk disease * Having an unrelated donor is considered a high-risk condition * Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center * Bone marrow donor available, meeting 1 of the following criteria: * Genotypically HLA-identical sibling * Phenotypically matched first-degree relative * Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1 PATIENT CHARACTERISTICS: Age * 6 months to 65 years Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent dexamethasone as an antiemetic during immunosuppression therapy Radiotherapy * Not specified Surgery * Not specified Other * No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)

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

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.

    PMID: 20124511RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesAnemia, Refractory, with Excess of BlastsCongenital AbnormalitiesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseLeukemia, Lymphocytic, Chronic, B-CellPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicHodgkin DiseaseLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, FollicularLymphoma, Mantle-CellRecurrenceLeukemia, Myelomonocytic, Chronic

Interventions

BusulfanCyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersAnemia, RefractoryAnemiaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidLeukemia, LymphoidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, B-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Leo Luznik, MD
Organization
Johns Hopkins University
luznile@jhmi.edu
4105027732

Study Officials

  • Leo Luznik, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

June 1, 2004

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 31, 2018

Results First Posted

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)