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Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • CCOP - Bay Area Tumor Institute
  • CCOP - Mount Sinai Medical Center
  • Regional Radiation Oncology Center at Rome
  • CCOP - Central Illinois
  • Kentuckiana Cancer Institute, PLLC
  • MBCCOP - LSU Health Sciences Center
  • Alamance Cancer Center
  • Hugh Chatham Memorial Hospital
  • Southeastern Medical Oncology Center
  • Brody School of Medicine at East Carolina University
  • Comprehensive Cancer Center at Wake Forest University
  • CCOP - Columbus
  • Cancer Centers of the Carolinas - Eastside
  • CCOP - Upstate Carolina

Outcomes

Primary Outcome Measures

Cytogenetic response (complete and partial)

Secondary Outcome Measures

Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Time to progression
Survival

Full Information

First Posted
November 4, 2003
Last Updated
January 17, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072579
Brief Title
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia. PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Primary Outcome Measure Information:
Title
Cytogenetic response (complete and partial)
Secondary Outcome Measure Information:
Title
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Title
Time to progression
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istvan Molnar, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bayard L. Powell, MD
Organizational Affiliation
Wake Forest University Health Sciences
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Regional Radiation Oncology Center at Rome
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Kentuckiana Cancer Institute, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Alamance Cancer Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Hugh Chatham Memorial Hospital
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
Cancer Centers of the Carolinas - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

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