NCT00002809

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Aug 1996

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

August 1, 1996

Completed
3.3 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
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

7.3 years

First QC Date

November 1, 1999

Last Update Submit

September 30, 2010

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionrefractory anemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationsecondary acute myeloid leukemiapreviously treated myelodysplastic syndromesatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, 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

anti-thymocyte globulinBIOLOGICAL
filgrastimBIOLOGICAL
sargramostimBIOLOGICAL
therapeutic immune globulinBIOLOGICAL
cyclophosphamideDRUG
methotrexateDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age17 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * One of the following hematologic malignancies/disorders: * Acute lymphoblastic leukemia * In second or subsequent complete remission (CR) * In first CR with high-risk features (e.g., Philadelphia chromosome-positive) * In first relapse and failed conventional salvage therapy * Acute myelogenous leukemia (AML) * In second or subsequent CR * In early first relapse * In full first relapse and failed conventional salvage therapy * In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7 * Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation * Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase * No blast crisis * Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy * Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events) * Myelodysplastic syndrome, i.e.: * Symptomatic, transfusion-dependent refractory anemia with excess blasts * (RAEB) or RAEB in transformation * Secondary leukemia in CR following conventional-dose induction chemotherapy * Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing * No CNS malignancy PATIENT CHARACTERISTICS: Age: * 17 to 60 Performance status: * Karnofsky 70-100% Life expectancy: * No reduction due to other serious illness Hematopoietic: * Not specified Hepatic: * Bilirubin less than 3 mg/dL * AST/ALT no greater than twice normal Renal: * Creatinine no greater than 2.0 mg/dL * Creatinine clearance greater than 60 mL/min Cardiovascular: * Left ventricular ejection fraction at least 45% * No severe hypertension Pulmonary: * DLCO, FEV\_1, and FVC at least 50% Other: * HIV negative * No active infection at time of transplant * No advanced diabetes * No significant neurologic deficit * No active drug or substance abuse * No emotional disorders * Able to participate in frequent medical care for at least 1-2 years * Willing to comply with National Marrow Donor Program policies 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)

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111-2442, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

Antilymphocyte SerumFilgrastimsargramostimgamma-GlobulinsCyclophosphamideMethotrexateTacrolimusRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMacrolidesLactonesTherapeutics

Study Officials

  • Kenneth F. Mangan, MD, FACP

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

August 1, 1996

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

US(1)