NCT00005622

Brief Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 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

May 1, 1996

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 25, 2012

Status Verified

October 1, 2012

Enrollment Period

9.3 years

First QC Date

May 2, 2000

Last Update Submit

October 24, 2012

Conditions

Chronic Myeloproliferative DisordersLeukemiaMultiple Myeloma and Malignant Plasma Cell NeoplasmsMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent childhood acute lymphoblastic leukemiarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic 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 remissionpolycythemia veraprimary myelofibrosisessential thrombocythemiarefractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrefractory cytopenia with multilineage dysplasiachronic eosinophilic leukemiachronic neutrophilic 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)childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • event free survival (EFS)

    EFS determined by the Kaplan-Meier product limit method

    five year post transplant

Secondary Outcomes (1)

  • Incidence of graft versus host disease

    five years post transplant

Study Arms (1)

Cy/TBI

OTHER

cyclophosphamide and total body irradiation (TBI)

Drug: cyclophosphamideRadiation: TBI

Interventions

cyclophosphamideDRUG

Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)

Cy/TBI
TBIRADIATION

FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.

Cy/TBI

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of one of the following: * Acute lymphocytic leukemia (ALL): * Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities) * CR2 * Induction failures * Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt * Acute myelogenous leukemia (AML): * CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities) * CR2 * Induction failures * Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt * Chronic myelogenous leukemia (CML): * Chronic phase (CP) 1 * Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant * Chronic lymphocytic leukemia (CLL): * Relapse - any stage; must have received no more than 3 prior regimens * Multiple myeloma: * At diagnosis - primary refractory * Relapse (no more than 2) - sensitive disease * Plasma cell leukemia * Inability to achieve a complete remission after autologous transplant (no older than 40) * Myelodysplasia - all subtypes * Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities * Severe aplastic anemia (SAA): * Very SAA - at diagnosis * SAA - induction therapy * Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch PATIENT CHARACTERISTICS: Age: * 15 to 50 Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT and SGPT no greater than 3 times normal * PT/PTT normal Renal: * Creatinine no greater than 2.0 mg/dL * Creatinine clearance at least 60 mL/min Cardiovascular: * Left ventricular ejection fraction at least 45% * No myocardial infarction within past 6 months * No uncontrolled arrhythmias Pulmonary: * FEV1 at least 50% * DLCO at least 50% predicted Other: * No active serious infection * HIV negative * Not pregnant or nursing * No uncontrolled diabetes mellitus or thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics 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)

Moffitt Cancer Center

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaMultiple MyelomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeCongenital Abnormalities

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLymphatic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Teresa Field, MD, PhD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

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

May 2, 2000

First Posted

January 27, 2003

Study Start

May 1, 1996

Primary Completion

September 1, 2005

Study Completion

July 1, 2009

Last Updated

October 25, 2012

Record last verified: 2012-10

Locations

US(1)