Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Plain-language summary

This study examines busulfan, fludarabine, and total-body irradiation as preparation before a stem cell transplant from a donor in patients with blood (hematologic) cancer. It enrolled patients with high-risk blood cancers such as acute leukemia, chronic leukemia, lymphoma, and multiple myeloma. The research was conducted in Phase 1/Phase 2 and has been completed.

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

Trial details

Phase

PHASE1/PHASE2

Status

Completed

Sponsor

OHSU Knight Cancer Institute

Intervention

therapeutic allogeneic lymphocytes, busulfan, cyclosporine, fludarabine phosphate, mycophenolate mofetil, peripheral blood stem cell transplantation, Total Body Irradiation (TBI), Granulocyte colony-stimulating factor (G-CSF), Phenytoin, Methotrexate

Start date

6/1/2005

Estimated completion

8/1/2015

Countries

United States

Related genes

Locations

• Portland, 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:

* Diagnosis of a hematologic malignancy of 1 of the following high-risk types:

  * Acute lymphoblastic leukemia
  * Acute myeloid leukemia
  * Chronic myelogenous leukemia
  * Chronic lymphocytic leukemia
  * Myelodysplastic syndromes
  * Myeloproliferative disorder
  * Multiple myeloma
  * Plasma cell dyscrasias
  * Non-Hodgkin lymphoma
  * Hodgkin disease

PATIENT CHARACTERISTICS:

Performance status

* Karnofsky 50-100%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* No liver failure
* No cirrhosis with evidence of portal hypertension
* No alcoholic hepatitis
* No esophageal varices
* No chronic hepatitis
* No other liver disease

Renal

* Not specified

Cardiovascular

* Left Ventricular Ejection Fraction (LVEF) \> 35%
* No symptomatic coronary artery disease or cardiac failure requiring therapy

Pulmonary

* Diffusing capacity of lung for carbon monoxide (DLCO) \> 30%
* Total lung capacity \> 30%
* Forced expiratory volume in 1 second (FEV\_1) \> 30%
* No supplementary continuous oxygen

Other

* HIV negative
* No active nonhematologic malignancy except localized skin cancer
* No overt organ dysfunction

PRIOR CONCURRENT THERAPY:

* Not specified