Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 65 Pharmaceutical / Industry JHOC-J9449 BRLX-001.0649, JHOC-94110404, NCI-V96-0900, NCT00002778

Objectives

1. 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.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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)

Expected Enrollment

A total of 40 patients will be accrued for this study within approximately 6-10 years.

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

B. Douglas Smith, MD, Principal investigator		Ph: 410-614-5068 Email: smithdo@jhmi.edu

Registry Information
Official Title		GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
Trial Start Date		1995-02-07
Registered in ClinicalTrials.gov		NCT00002778
Date Submitted to PDQ		1995-02-07
Information Last Verified		2004-11-18
NCI Grant/Contract Number		P01-CA15396, P30-CA06973

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