NCT00002778

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Feb 1995

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

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

February 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

April 1, 2011

Enrollment Period

10 years

First QC Date

November 1, 1999

Last Update Submit

July 19, 2011

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaPhiladelphia chromosome negative chronic myelogenous leukemiaatypical chronic myeloid leukemia

Interventions

sargramostimBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
allogeneic bone marrow transplantationPROCEDURE
in vitro-treated bone marrow transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia (CML) documented by cytogenetic and molecular analyses at Johns Hopkins * Philadelphia chromosome (Ph)-positive or -negative CML * Ph-negative CML allowed with presence of either: * BCR-ABL rearrangement (on molecular, fluorescent in situ hybridization, or polymerase chain reaction analyses) * p210 protein * One of the following: * Patient age 18 to 65 * Disease duration longer than 3 years * Accelerated phase CML * Accelerated phase diagnosis based on any of the following: * More than 10% to less than 30% blasts in blood or bone marrow * No hematologic response to prior conventional therapy (hydroxyurea or interferon) * Extramedullary disease (e.g., progressive splenomegaly or lymphadenopathy) * Basophilia greater than 10% in blood or bone marrow * Other cytogenetic abnormalities in addition to a single Ph chromosome * Second chronic phase * Failure on interferon suggested of patients over age 18 with chronic phase CML, with failure defined as: * No detectable Ph-negative metaphases in marrow after 6 months * No progressive increase in Ph-negative metaphases in marrow after 6-12 months * Less than 50% Ph-negative metaphases after 1 year * No complete cytogenetic remission after 2 years * Intolerance to interferon therapy * No blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML * The following conditions are allowed: * Leukocyte count abnormalities * Fibrosis * Anemia * Fever or bone pain * Thrombocytopenia * Bone marrow reticulin * Availability of an HLA-identical sibling donor * At least 3 years of age (priority given to donors over age 10) * Priority given to CMV-negative donor if patient CMV-negative * No medical or psychiatric condition that precludes transplant procedure PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * No history of intolerance to sargramostim (GM-CSF) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics 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 (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative Diseases

Study Officials

  • B. Douglas Smith, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

February 1, 1995

Primary Completion

February 1, 2005

Study Completion

July 1, 2010

Last Updated

July 20, 2011

Record last verified: 2011-04

Locations

US(1)