NCT00002792

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 1996

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, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

6.8 years

First QC Date

November 1, 1999

Last Update Submit

March 31, 2010

Conditions

Chronic Myeloproliferative DisordersLeukemiaMyelodysplastic/Myeloproliferative Diseases

Keywords

polycythemia verachronic idiopathic myelofibrosisessential thrombocythemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiable

Interventions

busulfanDRUG
cyclophosphamideDRUG
cyclosporineDRUG
methotrexateDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to: * Hemoglobin less than 10 g/dL * Platelet count less than 100,000/mm\^3 * Hepatomegaly (i.e., palpable liver edge 5 cm below costal margin) * Clinical requirement for splenectomy * Other myeloproliferative disorders in an IMF like myelofibrotic state eligible * No evidence of leukemic progression, e.g.: * Greater than 15% peripheral blood blasts * Fever or bone pain of unknown origin * Rapidly progressing splenomegaly * No other causes for myelofibrosis, such as: * Collagen vascular disorder * Lymphoma * Granulomatous infection * Metastatic carcinoma * Hairy cell leukemia * Myelodysplastic syndrome * No active central nervous system disease * One of the following donor/patient pairings is required: * Donor status: * Genotypic or phenotypic HLA-matched relative * Maximum patient age of 65 * One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor * Maximum patient age of 55 * Transplant on this protocol allowed for patients registered on protocol FHCRC-1106.00 PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2 times normal * SGPT no greater than 4 times normal Renal: * Creatinine no greater than two times normal OR * Creatinine clearance at least 50% Cardiovascular: * Ejection fraction at least 50% * Cardiac evaluation required if signs or symptoms of coronary artery disease or congestive heart failure Other: * HIV negative * No active infection * Patients excluded from this protocol are referred to protocol FHCRC-179.05 PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified 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)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Anderson JE, Sale G, Appelbaum FR, Chauncey TR, Storb R. Allogeneic marrow transplantation for primary myelofibrosis and myelofibrosis secondary to polycythaemia vera or essential thrombocytosis. Br J Haematol. 1997 Sep;98(4):1010-6. doi: 10.1046/j.1365-2141.1997.3083125.x.

    PMID: 9326205RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaMyelodysplastic-Myeloproliferative DiseasesPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

BusulfanCyclophosphamideCyclosporineMethotrexateTacrolimusPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesLactonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • H. Joachim Deeg, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1996

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)