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Radiation Therapy + Chemotherapy Before Stem Cell Transplant for Leukemia

Phase 1
Waitlist Available
Led By Joseph Rosenthal
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
Patients meeting specific criteria for acute myelogenous leukemia or acute lymphocytic leukemia
Patients with myelodysplastic syndrome in high-intermediate and high risk categories
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of radiation therapy targeting bone marrow and blood when given with chemotherapy before a stem cell transplant from a donor.

Who is the study for?
This trial is for patients with myelodysplastic syndrome or acute leukemia who are in remission but at high risk of relapse, have good heart function and overall health, and no severe organ damage. They must be able to use birth control and have a partially matched related donor ready for stem cell donation. People with active infections or unable to tolerate certain therapies cannot participate.Check my eligibility
What is being tested?
The study tests the safety and optimal dose of total marrow and lymphoid irradiation combined with chemotherapy before a stem cell transplant from a donor. The goal is to target cancer cells in the bone marrow without harming other parts of the body too much.See study design
What are the potential side effects?
Potential side effects include damage to normal blood cells leading to low blood counts, increased risk of infection, fatigue, nausea, mouth sores due to chemotherapy; radiation may cause localized skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with acute myelogenous leukemia or acute lymphocytic leukemia.
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My condition is a high-risk type of blood disorder.
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I haven't had intensive cancer treatment for the last 3 weeks.
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My donor is a family member who matches half of my HLA markers.
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My cancer diagnosis is confirmed and falls under specific blood cancer types.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicity (DLT) scored on both the Bearman Scale and National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Maximum tolerated dose of TMLI when given in combination with fludarabine phosphate and cyclophosphamide, defined as the highest dose where 6 patients have been treated and at most one patient experiences DLT
Secondary outcome measures
Complete remission proportion
Immune reconstitution of B, T and NK cells
Incidence of acute GVHD of grades 2-4 and 3-4
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TMLI, chemotherapy, transplant, GVHD prophylaxis)Experimental Treatment8 Interventions
CONDITIONING: Patients undergo TMLI BID on days -7 to -4 or -3 (depending on the dose level). Patients also receive fludarabine phosphate IV on days -7 to -3 and cyclophosphamide IV on days -7, -6, 3, and 4. TRANSPLANT: Patients undergo bone marrow or peripheral blood stem cell transplant on day 0. GHVD PROPHYLAXIS: Patients receive tacrolimus* IV QD or PO BID on days 5-180. Patients also receive mycophenolate mofetil PO TID or IV on days 5-35. Treatment with tacrolimus and mycophenolate mofetil may continue in the presence of active GVHD. *NOTE: Patients intolerant of tacrolimus may receive cyclosporine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Transplantation
2012
Completed Phase 3
~270
Cyclophosphamide
1995
Completed Phase 3
~3780
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Tacrolimus
2011
Completed Phase 4
~4740
Total Marrow Irradiation
2014
Completed Phase 1
~20
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,622 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,428 Total Patients Enrolled
Joseph RosenthalPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for this research?

"Unfortunately, patient recruitment for this trial has ended. Initially posted on June 25th 2015 and last updated on February 17th 2022; those seeking alternatives can explore the 3762 studies that are actively recruiting patients with adult acute lymphoblastic leukemia in remission or one of the 1002 Bone Marrow Transplantation trials currently underway."

Answered by AI

Which patient demographics are eligible to join this experiment?

"This trial is recruiting a total of 24 individuals, aged 12 to 60 years old, who have achieved complete remission from adult acute lymphoblastic leukemia."

Answered by AI

What are some historical examples of research pertaining to Bone Marrow Transplantation?

"Currently, there are 1,002 clinical trials related to Bone Marrow Transplantation. Of those studies, 182 have advanced into Phase 3 testing. Philadelphia, Pennsylvania has the most research sites with 29386 locations running these trials."

Answered by AI

Is Bone Marrow Transplantation endorsed by the FDA?

"Due to the limited data that exists in regards to Bone Marrow Transplantation, our team has assigned it a safety level of 1. This is due to its Phase 1 status which indicates an absence of supportive evidence for both efficacy and security."

Answered by AI

Is this medical research including individuals aged eighty-five or older?

"This trial is accepting patients aged 12 to 60, though there are separate clinical trials for those younger and older. Specifically, 1,289 studies cater specifically to minors while 3,722 offer assistance to seniors."

Answered by AI

In what situations is Bone Marrow Transplantation typically employed?

"Bone Marrow Transplantation is a popular treatment for dermatitis, atopic and other conditions such as multiple sclerosis, leukemia, myelocytic acute, transplant rejection and kidney failure."

Answered by AI

What is the aggregate quantity of individuals involved in this experiment?

"Unfortunately, enrollment for this trial has finished. It was first made available on June 25th 2015 but had its last update recorded February 17th 2022. If you are seeking alternative clinical trials, there are 3762 active studies recruiting adult acute lymphoblastic leukemia patients in complete remission and 1002 researching Bone Marrow Transplantation that remain open to new participants."

Answered by AI
~0 spots leftby Jun 2024