NCT00044954

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation 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 combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1999

Typical duration for phase_2 leukemia

Geographic Reach
1 country

14 active sites

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

November 1, 1999

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

7 years

First QC Date

September 6, 2002

Last Update Submit

September 13, 2019

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent adult Hodgkin lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiaadult acute myeloid leukemia in remissionrecurrent grade 3 follicular lymphomarecurrent adult diffuse large cell lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarefractory multiple myelomastage I mantle cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablerefractory chronic lymphocytic leukemiaadult 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

therapeutic allogeneic lymphocytesBIOLOGICAL
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following hematologic malignancies: * Chronic myelogenous leukemia (CML) * First or second chronic phase * Accelerated phase * Acute myelogenous leukemia (AML) * At least second remission * First remission allowed if poor-risk features are present (complex chromosome karyotype, abnormalities of chromosomes, especially 5 or 7, 12p-, +13, +8, t\[9:11\]) * Myelodysplastic syndromes (MDS) * Intermediate- or high-risk disease by the prognostic scoring system * Multiple myeloma (MM) * Hodgkin's lymphoma * Second or greater relapse * First relapse allowed if disease-free interval is less than 1 year * Ineligible for autologous transplantation * Non-Hodgkin's lymphoma (NHL) * Grade III follicular large cell (relapsed after one course of prior chemotherapy) * Diffuse large cell (relapsed after one course of prior chemotherapy) * Mantle cell * Chronic lymphocytic leukemia (CLL) * Relapsed after at least 1 course of prior therapy * Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor PATIENT CHARACTERISTICS: Age * 18 to 75 for patients with MM * 50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL * 18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT Performance status * Zubrod 0-2 Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 3 mg/dL Renal * Creatinine no greater than 2 mg/dL Cardiovascular * LVEF at least 40% by MUGA or echocardiogram Pulmonary * DLCO at least 50% of predicted Other * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No recent history of drug or alcohol abuse * No other prior malignancy except basal cell skin cancer * No uncontrolled bacterial, viral, fungal, or parasitic infections PRIOR CONCURRENT THERAPY: Biologic therapy * Prior autologous transplantation allowed if disease progression occurred * No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol 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 (14)

Rocky Mountain Cancer Centers - Denver Midtown

Denver, Colorado, 80218, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342-4777, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Kansas City Cancer Centers - Central

Kansas City, Missouri, 64111, United States

Location

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37212, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75235-8590, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesHodgkin DiseaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

Cyclosporinefludarabine phosphateMycophenolic AcidPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Robert H. Collins, MD

    Simmons Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

November 1, 1999

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

US(14)