Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Tracking Information
First Submitted Date ICMJE	November 1, 1999
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	July 20, 2011
Study Start Date ICMJE	February 1995
Actual Primary Completion Date	February 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002778 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Official Title ICMJE	GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
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.
Detailed Description	OBJECTIVES: Determine whether the use of sargramostim (GM-CSF) after T-cell depleted, CD34-positive cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in patients with chronic myelogenous leukemia. OUTLINE: Patients receive myeloablation with busulfan and cyclophosphamide on an approved protocol. Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody. T-cell depleted, CD34-positive cell-supplemented bone marrow is infused on day 0. Patients receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60. Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation without GM-CSF is considered in case of primary or secondary engraftment failure. Patients are followed every month for 3 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 6-10 years.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia
Intervention ICMJE	Biological: sargramostim; Biological: therapeutic allogeneic lymphocytes; Procedure: allogeneic bone marrow transplantation; Procedure: in vitro-treated bone marrow transplantation
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Estimated Enrollment ICMJE; (submitted: February 8, 2007)	40
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	July 2010
Actual Primary Completion Date	February 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00002778
Other Study ID Numbers ICMJE	CDR0000064783; P01CA015396 ( U.S. NIH Grant/Contract ); P30CA006973 ( U.S. NIH Grant/Contract ); JHOC-J9449; BRLX-001.0649; JHOC-94110404; NCI-V96-0900
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Sidney Kimmel Comprehensive Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: B. Douglas Smith, MD Sidney Kimmel Comprehensive Cancer Center
PRS Account	Sidney Kimmel Comprehensive Cancer Center
Verification Date	April 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP