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AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE


OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone
marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone
marrow with normal stem cells in patients treated with high-dose busulfan and
cyclophosphamide followed by autologous bone marrow transplantation using marrow treated
with c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of
hematopoietic reconstitution, overall survival, and relapse-free survival of patients
treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb
antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved
untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on
days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on
days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF)
subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients
are followed every 2-3 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically and cytologically proven chronic myelogenous
leukemia Accelerated phase OR Chronic phase No hypocellular marrow (less than 25%
cellularity) No patients under age 55 with a HLA-matched sibling donor

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: 0-1 Hematopoietic: Granulocyte
count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin
less than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine less than 2.0 mg/dL
Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection
fraction normal No significant cardiac disease requiring digoxin, diuretics,
antiarrhythmics, or antianginal medications Pulmonary: PFTs normal DLCO normal Other: No
persistent infection requiring antibiotics No concurrent organ damage or medical problem
that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior interferon
therapy Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not
specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Selina M. Luger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000063772

NCT ID:

NCT00002592

Start Date:

June 1993

Completion Date:

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104