Chemoradiotherapy + Stem Cell Transplant for Blood Cancers

Phase 1 & 2

Waitlist Available

Led By Joseph Rosenthal, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 180 days post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is giving chemotherapy drugs and HT before a donor stem cell transplant to see if it helps stop the growth of cancer cells and also helps stop the patient's immune system from rejecting the donor's stem cells.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions to chemotherapy such as nausea, fatigue, risk of infection due to low blood counts; complications from radiation therapy; and issues related to stem cell transplantation like graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 180 days post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 180 days post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 180 days post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.

Secondary study objectives

Overall Survival on Day 180 Days Post-transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (enzyme inhibitor, radiation therapy, transplant)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fludarabine phosphate

2000

Completed Phase 3

~2660

allogeneic hematopoietic stem cell transplantation

2005

Completed Phase 3

~890