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Alkylating agents
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.
Secondary outcome measures
Overall Survival on Day 180 Days Post-transplant
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
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
melphalan
1994
Completed Phase 3
~3530
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,385 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,078 Total Patients Enrolled
Joseph Rosenthal, MDPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have Hepatitis B, C, or cirrhosis.I have not had a serious infection in the last 4 weeks.I do not have any uncontrolled infections.My lung scans are clear of active disease, confirmed by a biopsy.I have Fanconi Anemia.I can lie on my back for 30 minutes without moving, even if it means I might need sedation.I do not have major health or mental health issues that would make this treatment hard for me.I have been diagnosed with AML, MDS (intermediate/high-risk), or ALL.My heart pumps well, with an ejection fraction over 50%.I am mostly active and can care for myself.My lung function is confirmed to be good by tests or a doctor's assessment.My kidneys are working well, with a filtration rate over 60 cc/min.My pre-treatment tests were done within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enzyme inhibitor, radiation therapy, transplant)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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