Trials Sponsors Conditions Drugs Pricing

Conditions

Graft Versus Host Disease Leukemia Lymphoma

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

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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
cyclosporine and methotrexate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

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

Sponsors & Collaborators

Baxalta now part of Shire
Industrylead

Study Sites (13)

Los Angeles, California, United States

Jacksonville, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Lawrence, Kansas, United States

Saint Paul, Minnesota, United States

Kansas City, Missouri, United States

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

Study Officials

Study Director
Takeda
STUDY DIRECTOR

Enrollment

105 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

Unselected peripheral blood haemopoietic stem cells (PBSC)

CD34+ cells isolated from PBSC

Interventions

Registry intervention entries

Eligibility Criteria

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

Unselected peripheral blood haemopoietic stem cells (PBSC)

CD34+ cells isolated from PBSC

Interventions

Registry intervention entries

Eligibility Criteria

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Source record

Locations