Study on Helical Tomotherapy, Fludarabine, and Melphalan Followed by Donor Stem Cell Transplant for Blood Cancers

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT00544466

Provider View

This clinical trial is exploring a treatment that combines radiation therapy, chemotherapy, and a donor stem cell transplant to help treat patients with certain blood cancers. The study aims to see if this combination can safely and effectively prepare patients for a stem cell transplant.

Patient Parameters

Program Overview

The purpose of this study is to test a treatment that uses radiation therapy (Helical Tomotherapy), along with chemotherapy drugs fludarabine and melphalan, before a donor stem cell transplant. This approach is designed to stop cancer cells from growing and help the patient's body accept the donor's stem cells. The healthy stem cells from the donor can help the patient's bone marrow produce new blood cells. The study aims to see if this combination can safely prepare patients with blood cancers like acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS) for a successful transplant.

Description

This study involves using a combination of treatments to prepare patients with certain blood cancers for a stem cell transplant. The treatment includes:

  • Radiation Therapy (Helical Tomotherapy): This is a type of radiation treatment that targets cancer cells while sparing healthy tissue. Patients will receive this therapy twice a day for four days.

  • Chemotherapy: Patients will receive two chemotherapy drugs, fludarabine and melphalan, to help stop cancer cells from growing and to prepare the body for the transplant. Fludarabine is given over five days, and melphalan is given on one day.

  • Stem Cell Transplant: On the day of the transplant, patients will receive healthy stem cells from a donor. These stem cells can help the patient's bone marrow produce new blood cells.

The study will monitor the safety and effectiveness of this treatment combination, including how well patients recover and how their cancer responds. Patients will be followed for two years after the treatment to check on their health and progress.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of one of the following blood cancers: acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) with intermediate or high-risk disease, or acute lymphoblastic leukemia (ALL).
  • Children and adults of any age with significant health issues, as determined by the primary doctor and approved by the study leader.
  • Able to lie still for about 30 minutes during treatment sessions; younger patients may need sedation.
  • Good overall health with a performance status score of 70% or higher.
  • Adequate heart function with a heart pumping ability over 50%.
  • Adequate lung function; for young children, a pediatrician or lung specialist will assess.
  • Good kidney function with a creatinine clearance or GFR over 60 cc/min.
  • Liver enzymes within five times the normal limit.
  • Less than 15% cancer cells in the blood.
  • Pre-treatment tests done within 30 days before starting chemotherapy.
  • No other medical or psychological issues that would make the treatment too risky.

Exclusion Criteria

  • Patients with a type of leukemia that doesn't show specific markers (Acute Undifferentiated Leukemia).
  • Previous radiation to more than 20% of bone marrow areas or any area over 2000 cGy.
  • Patients with Fanconi Anemia.
  • Major medical or psychiatric disorders that would make the treatment difficult to tolerate.
  • HIV infection.
  • Evidence of Hepatitis B or C infection or liver cirrhosis.
  • Uncontrolled infections, including viral, bacterial, or fungal.
  • Recent serious infections within the last four weeks.
  • Lung disease indicated by scans, unless cleared by a biopsy showing no active disease.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010-3000DuarteCalifornia

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