Completed

Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy

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What is being tested

Data Collection

Who is being recruted

Bone Marrow Diseases
+9

+ Chronic Disease
+ Hematologic Diseases
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy. OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 weeks. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.

Official TitlePhase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy 
NCT00072579
Principal SponsorWake Forest University Health Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bone Marrow Diseases
Chronic Disease
Hematologic Diseases
Leukemia
Leukemia, Myeloid
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Disease Attributes
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed chronic phase chronic myelogenous leukemia (CML) * Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow * Complete hematologic remission during prior therapy\* as seen on 2 separate blood count analyses, defined by the following: * WBC no greater than 10,000/mm\^3 AND platelet count no greater than 450,000/mm\^3 * Disappearance of all signs and symptoms of disease, including palpable splenomegaly * Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: \*Continuation of therapy that led to complete hematologic remission is required during study participation * Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day * Not in complete cytogenetic remission within 30 days of study entry * Persistent Philadelphia chromosome by bone marrow exam PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled active infective * No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months * No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Prior sargramostim (GM-CSF) allowed * Prior interferon alfa for CML allowed * No prior stem cell transplantation * Concurrent interferon alfa\* for CML allowed NOTE: \*No dose increase during study participation Chemotherapy * At least 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 4 weeks since prior surgery Other * Prior imatinib mesylate for CML allowed * No other concurrent medication for CML * Concurrent imatinib mesylate\* for CML allowed NOTE: \*No dose increase during study participation


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 15 locations
Suspended
CCOP - Western Regional, ArizonaPhoenix, United StatesSee the location
Suspended
CCOP - Bay Area Tumor InstituteOakland, United States
Suspended
CCOP - Mount Sinai Medical CenterMiami Beach, United States
Suspended
Regional Radiation Oncology Center at RomeRome, United States

Completed15 Study Centers
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