Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Plain-language summary

This Phase 2 trial at the Abramson Cancer Center at Penn Medicine studied the effectiveness of chemotherapy followed by autologous bone marrow transplantation in patients with chronic myelogenous leukemia (CML). The regimen used bone marrow treated in vitro with the c-myb antisense oligonucleotide G4460, along with filgrastim, busulfan and cyclophosphamide; combining chemotherapy with transplantation is intended to allow higher chemotherapy doses. Participants were aged 18 to 60 with histologically and cytologically proven CML in accelerated or chronic phase; the trial is completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Abramson Cancer Center at Penn Medicine

Intervention

c-myb antisense oligonucleotide G4460, filgrastim, busulfan, cyclophosphamide, autologous bone marrow transplantation, in vitro-treated bone marrow transplantation

Start date

6/1/1993

Estimated completion

8/1/2002

Countries

United States

Related genes

Locations

• Philadelphia, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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