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Anti-metabolites
Marrow Irradiation + Chemotherapy for Leukemia
Phase 1
Recruiting
Led By Monzr Al Malki
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of total marrow and lymphoid irradiation when given with fludarabine and melphalan before a donor stem cell transplant in people with high-risk acute leukemia or myelodysplastic syndrome.
Who is the study for?
This trial is for people with high-risk acute leukemia or myelodysplastic syndrome who haven't had more than three intensive chemotherapy treatments and no previous transplants. Participants should be between 12-55 years old, have a certain level of physical fitness, and proper organ function. Women and men must use birth control during the study.
What is being tested?
The trial tests how safe and effective it is to give total marrow and lymphoid irradiation with fludarabine and melphalan before a stem cell transplant from a donor. The goal is to see if this combination can help stop cancer growth in bone marrow before the transplant.
What are the potential side effects?
Possible side effects include reactions to the drugs like nausea, fatigue, mouth sores, low blood counts leading to infection risk or bleeding problems. Irradiation may cause skin irritation or discomfort at the site of treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of toxicity
Secondary study objectives
Acute graft versus host disease of grades 2-4 and 3-4
Bone marrow (BM) residual damage
CD4+, CD8+ and CD56+16+
+9 moreSide effects data
From 2016 Phase 1 trial • 12 Patients • NCT0204384733%
Mucositis
33%
Diarrhea
33%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1Total Marrow Irradiation (TMI) 3Gy
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
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 (TMLI, fludarabine, melphalan)Experimental Treatment4 Interventions
Participants undergo TMLI BID on days -8 to -5, and receive fludarabine IV on days -4 to -2 and melphalan on day -2. Participants then undergo alloHCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Melphalan
2008
Completed Phase 3
~1500
Total Marrow Irradiation
2014
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,544 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,429 Total Patients Enrolled
Monzr Al MalkiPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form for the study.I am on low dose or maintenance chemotherapy like hydroxyurea or TKIs.I do not have any uncontrolled illnesses or infections.I haven't had experimental treatments or intense cancer therapy in the last 2 weeks.You have had allergic reactions to similar medicines or substances that are similar to the ones used in this study.I have no other cancers except for non-melanoma skin cancers.My cancer diagnosis is a type of blood cancer.I, as a donor, have health issues that prevent me from undergoing growth factor therapy or leukapheresis.You have another medical condition or a problem with your brain or emotions that would make it hard for you to follow the treatment plan or handle the transplant, or that would make it take longer for your blood to get back to normal.I have not had a bone marrow or stem cell transplant.I have had 3 or fewer intensive chemotherapy treatments to try to cure my cancer.I am a donor and have been approved for bone marrow donation because other methods may be risky for me.My AML is classified as high or intermediate risk, excluding FLT3-NPM1+.My condition is acute lymphocytic leukemia.My disease is currently active.My leukemia has specific genetic features or high white blood cell counts.I am mostly able to care for myself but may need help.I am on low dose chemotherapy or maintenance drugs like hydroxyurea or TKIs.My donor is a family member who partially matches my tissue type and no exact match is available.I have a sibling or an unrelated donor who matches me perfectly for a stem cell or bone marrow donation.I have not had radiation to my lung, liver, or kidney.My condition is a high-risk type of bone marrow disorder.I am between 12 and 55 years old and cannot undergo intense treatment due to other health issues.My kidneys are functioning well, with a creatinine clearance of 60 ml/min or more.My cancer responds well to chemotherapy.I have acute myelogenous leukemia.I stopped all intense cancer treatments 2 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TMLI, fludarabine, melphalan)
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.
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