NCT00025545

Brief Summary

RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia. PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 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

March 1, 1996

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
Last Updated

May 13, 2010

Status Verified

May 1, 2010

Enrollment Period

6.6 years

First QC Date

October 11, 2001

Last Update Submit

May 12, 2010

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionacute undifferentiated leukemiasecondary acute myeloid leukemia

Interventions

cyclophosphamideDRUG
methotrexateDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Primary acute leukemia beyond first remission * High-risk acute myelogenous leukemia * Acute lymphoblastic leukemia in first remission * Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles * No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype * No leukoencephalopathy PATIENT CHARACTERISTICS: Age: * 55 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * SGOT no greater than 2 times normal * Hepatitis B surface antigen negative * No prior hepatitis C Renal: * No impaired renal function * Creatinine less than 2 times normal Cardiovascular: * No symptomatic cardiac disease Pulmonary: * No active pulmonary disease * DLCO at least 60% predicted Other: * HIV negative * No disease or other malignancy that severely limits life expectancy * No severe or life-threatening infection within the past 2 weeks * No history of septate fungal infection or disseminated candidiasis PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or peripheral blood stem cell transplantation Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy greater than 3,000 cGy to whole brain * No prior radiotherapy of 1,500 cGy to chest or abdomen * At least 6 months since prior involved-field radiotherapy to chest or abdomen 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)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, Acute

Interventions

CyclophosphamideMethotrexatePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Claudio Anasetti, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 11, 2001

First Posted

June 20, 2003

Study Start

March 1, 1996

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

May 13, 2010

Record last verified: 2010-05

Locations

US(1)