NCT00003056

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host disease during peripheral stem cell transplantation in patients who have advanced leukemia or lymphoma who are eligible for transplanted peripheral stem cells from a donor.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
105

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started Apr 1997

Geographic Reach
2 countries

13 active sites

Status
terminated

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

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 24, 2004

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

May 3, 2021

Conditions

LeukemiaLymphomaGraft Versus Host Disease

Keywords

recurrent adult diffuse small cleaved cell lymphomaadult acute myeloid leukemia in remissionrecurrent grade 2 follicular lymphomaaccelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionrecurrent grade 1 follicular lymphomarecurrent adult lymphoblastic lymphomarecurrent marginal zone lymphomachronic phase chronic myelogenous leukemiarecurrent small lymphocytic lymphomarecurrent grade 3 follicular lymphomarecurrent adult Hodgkin lymphomarecurrent adult acute lymphoblastic leukemiarecurrent adult immunoblastic large cell lymphomagraft versus host diseaserecurrent adult diffuse mixed cell lymphomarecurrent mantle cell lymphomasplenic marginal zone lymphomarecurrent adult acute myeloid leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuerecurrent adult diffuse large cell lymphomanodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphoma

Outcome Measures

Primary Outcomes (6)

  • Time to neutrophil engraftment

    Month 1, post-transplant

  • Time to neutrophil engraftment

    Month 2, post-transplant

  • Time to neutrophil engraftment

    Month 3, post-transplant

  • Time to neutrophil engraftment

    Month 4, post-transplant

  • Time to neutrophil engraftment

    Month 5, post-transplant

  • Time to neutrophil engraftment

    Month 6, post-transplant

Study Arms (2)

Unselected peripheral blood haemopoietic stem cells (PBSC)

ACTIVE COMPARATOR

Unselected PBSC together with control graft versus host disease (GVHD) prophylaxis - Control

Drug: cyclosporine and methotrexate

CD34+ cells isolated from PBSC

EXPERIMENTAL

CD34+ cells isolated from PBSC using the Isolex 300i system together with cyclosporine

Drug: cyclosporine

Interventions

cyclosporineDRUG
CD34+ cells isolated from PBSC
cyclosporine and methotrexateDRUG
Unselected peripheral blood haemopoietic stem cells (PBSC)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: - Acute lymphocytic leukemia (ALL) with documented chemosensitivity (complete response \[CR\], partial response \[PR\], or minor response \[MR\]) in first or second remission, first or second relapse, or high risk ALL with Ph positive 9/22 translocation; OR - Acute myelogenous leukemia (AML) with documented chemosensitivity (CR, PR, or MR) in first or second remission, or first or second relapse; OR - Chronic myelogenous leukemia (CML), chronic or accelerated, that is not in blast crisis; OR - Hodgkin's disease or non-Hodgkin's lymphoma with documented chemosensitivity in first or second relapse Consenting human lymphocyte antigen (HLA)-identical related donor required No active central nervous system (CNS) or skin leukemia involvement No disease that requires additional mediastinal radiation PATIENT CHARACTERISTICS: Age: 18-55 Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times normal serum glutamate oxalo-acetate transaminase (SGOT) less than 2 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at rest at least 40% or within normal range Pulmonary: diffusing capacity of the lung for carbon monoxide (DLCO) greater than 45% of predicted or within normal range Other: HIV negative At least 2 weeks since any active infection requiring intravenous treatment with antifungal, antibacterial or antiviral agents with the exception of coagulase negative staphylococcal line infection No coexisting medical problems that would significantly increase the risk of the transplant procedure Not pregnant or nursing PRIOR CONCURRENT THERAPY: No more that 2 prior therapy regimens Biologic therapy: No prior autologous or allogeneic bone marrow or peripheral blood stem cell transplant Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy subject to dose requirements Surgery: Not specified Other: At least 2 weeks since intravenous treatment with antifungal, antibacterial or antiviral agents, except for treatment of coagulase negative staphylococcal infection of an IV or central line

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

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Lawrence, Kansas, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

LeukemiaLymphomaGraft vs Host DiseaseLymphoma, Non-HodgkinLymphoma, FollicularLeukemia, Myeloid, Accelerated PhasePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal ZoneLeukemia, Myeloid, Chronic-PhaseLeukemia, Lymphocytic, Chronic, B-CellHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, Mantle-CellLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseBurkitt Lymphoma

Interventions

CyclosporineMethotrexate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoma, B-CellLeukemia, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 24, 2004

Study Start

April 1, 1997

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations

AU(1)US(12)