Chemoradiotherapy + Stem Cell Transplant for Blood Cancers

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: City of Hope Medical Center

Disqualifiers: AUL, Fanconi Anemia, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and HT before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving HT together with fludarabine phosphate and melphalan before a transplant may stop this from happening. PURPOSE: This clinical trial studies helical tomotherapy (HT), fludarabine phosphate, and melphalan followed by donor stem cell transplant in treating patients with hematologic malignancies.

Research Team

Joseph Rosenthal, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with certain blood cancers like AML, high-risk MDS, or ALL. They must be able to lie still in a body cast for treatment sessions and have good heart, lung, liver, and kidney function. Excluded are those with specific leukemia types (AUL), prior extensive radiation therapy, HIV infection, uncontrolled infections or serious recent infections.

Inclusion Criteria

I can lie on my back for 30 minutes without moving, even if it means I might need sedation.

Patients must have less than 15% peripheral blasts

Recipient, or recipient's parents, or recipient's legal guardians must have signed a voluntary, informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

I have had radiation therapy to a large part of my bone marrow or received high-dose radiation.

My leukemia does not show specific cell type markers.

I am HIV positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparative Regimen

Participants receive fludarabine phosphate IV on days -7 to -3, melphalan IV on day -2, and undergo helical tomotherapy twice daily on days -7 to -4

1 week

Transplantation

Participants undergo allogeneic hematopoietic stem cell transplantation on day 0

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation
• Fludarabine Phosphate
• Helical Tomotherapy
• Melphalan

Trial Overview The study tests helical tomotherapy (HT) combined with chemotherapy drugs fludarabine phosphate and melphalan before an allogeneic stem cell transplant from a donor. The goal is to stop cancer growth and prevent immune rejection of the transplanted cells.

Participant Groups

Group I: Treatment (enzyme inhibitor, radiation therapy, transplant) Experimental Treatment 4 Interventions

PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis.

Fludarabine Phosphate is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma
• Acute myeloid leukemia

Approved in European Union as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma
• Acute myeloid leukemia

Approved in Canada as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma
• Acute myeloid leukemia

Approved in Japan as Fludara for:

• Chronic lymphocytic leukemia
• Non-Hodgkin's lymphoma
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+