Know Cancer

or
forgot password

GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA


Phase 2
18 Years
65 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

B. Douglas Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064783

NCT ID:

NCT00002778

Start Date:

February 1995

Completion Date:

July 2010

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • atypical chronic myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410