NCT00011934

Brief Summary

RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow and may help a person's immune system recover from the side effects of the chemotherapy used in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation, chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1998

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

March 3, 2001

Last Update Submit

April 16, 2014

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaPhiladelphia chromosome negative chronic myelogenous leukemia

Interventions

recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
autologous bone marrow transplantationPROCEDURE

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myeloid leukemia (CML) by cytogenetic and/or molecular analyses No more than 10% blasts on blood and bone marrow morphology Philadelphia (Ph) chromosome positive Ph chromosome-negative CML allowed if evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the P120 protein Duration of CML less than 3 years, unless cytogenetic remission to interferon has been achieved Failed to obtain and maintain a complete cytogenetic remission on a prior trial of interferon therapy Absence of detectable PH-negative cells in bone marrow or blood after 6 months of therapy Lack of a progressive increase in Ph-negative cells between 6 and 12 months of therapy Less than 50% Ph-negative cells after 12 months of therapy Absence of complete cytogenetic remission after 24 months of therapy Inability to tolerate prior interferon therapy No accelerated phase or blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML Concurrent enrollment on the busulfan and cyclophosphamide preparative regimen protocol PATIENT CHARACTERISTICS: Age: 12 to 70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of intolerance to sargramostim (GM-CSF) PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Interferon-alphasargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • B. Douglas Smith, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2001

First Posted

May 4, 2004

Study Start

May 1, 1998

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

US(1)