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Radiation

Total Marrow Irradiation + Stem Cell Transplant for Leukemia

Phase 2
Recruiting
Led By Monzr M 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
Karnofsky performance status >= 70
- Patients with acute myelogenous leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of protocol therapy to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, death, relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years post-transplant
Awards & highlights

Study Summary

This trial is testing how well total body irradiation works as a way to prepare for hematopoietic cell transplantation in patients with myelodysplastic syndrome or acute leukemia. Total body irradiation can help lower the relapse rate, but there are some fatal side effects, like damage to normal organs that's irreversible, and graft-versus-host disease. With total body irradiation, radiation is directed at the entire body in an attempt to suppress the immune system, prevent rejection of the transplanted bone marrow and/or stem cells, and wipe out any remaining cancer cells. Intensity-modulated radiation therapy is a

Who is the study for?
This trial is for patients with certain types of leukemia or myelodysplastic syndrome who are in remission but at high risk, or have responsive disease. They need good organ function and performance status, no HIV/HBV/HCV, and a related half-matched donor ready. Pregnant women and those with recent intensive treatments or other health issues that could interfere are excluded.Check my eligibility
What is being tested?
The study tests total marrow and lymphoid irradiation as preparation before hematopoietic cell transplantation. It aims to see if this targeted radiation method can reduce cancer relapse while minimizing damage to healthy organs compared to traditional full-body radiation.See study design
What are the potential side effects?
Potential side effects include damage to normal organs, graft-versus-host disease where the body's immune system attacks the new cells, infection risks due to weakened immunity from conditioning treatment, and general complications from bone marrow transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of protocol therapy to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, death, relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of protocol therapy to grade 3-4 acute gvhd, chronic gvhd requiring systemic treatment, death, relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft-versus-host disease (GvHD) free relapse-free survival
Incidence of adverse events
Secondary outcome measures
Complete remission proportion
Incidence of acute GvHD of grades 2-4 and 3-4
Incidence of adverse events that meet grade 3, 4, or 5 per CTCAE version 5.0
+8 more
Other outcome measures
Effect of TMLI on bone marrow environment
GvHD biomarker analysis
Immune cell recovery
+2 more

Side effects data

From 2010 Phase 2 trial • 21 Patients • NCT00060424
48%
Neutropenia
10%
Death following disease progression post transplant
10%
Thrombocytopenia
10%
Hyperbilirubinemia
10%
Hypoxia
5%
Typhlitis & Bowel Perforation
5%
Death following progression of GVHD
5%
Cardiac Arrhythmia and Seizure
5%
Death: Sepsis/Renal failure/ with history of GVHD
5%
Severe abnormal pain due to gut GVH
5%
Acute Pulmonary Embolism
5%
Perforated sigmoid diverticulitis
5%
Minimal hydronephosis
5%
Cholecystectomy
5%
Hypotension
5%
Increased creatinine
5%
Neurotoxicity
5%
Renal failure
5%
Tumor lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (fludarabine, TMLI, HCT, cyclophosphamide)Experimental Treatment8 Interventions
CONDITIONING: Patients receive fludarabine IV QD on days -7 to -5, and undergo TMLI BID on days -4 to 0 in the absence of disease progression or unacceptable toxicity. TRANSPLANT: Patients undergo hematopoietic cell transplantation on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV QD on days 3-4 in the absence of disease progression or unacceptable toxicity. Beginning on day 5, patients also receive granulocyte colony stimulating factor and tacrolimus/mycophenolate mofetil per institutional standard.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Fludarabine
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Filgrastim
FDA approved
Mycophenolate mofetil
FDA approved
Fludarabine
FDA approved
Tacrolimus
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,323 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,390 Total Patients Enrolled
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
264 Total Patients Enrolled

Media Library

Total Marrow and Lymphoid Irradiation (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04262843 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (fludarabine, TMLI, HCT, cyclophosphamide)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Total Marrow and Lymphoid Irradiation Highlights & Side Effects. Trial Name: NCT04262843 — Phase 2
Total Marrow and Lymphoid Irradiation (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04262843 — Phase 2

Frequently Asked Questions

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

What is the population size receiving treatment in this research endeavor?

"Affirmative. According to clinicaltrials.gov, recruitment is ongoing for this medical experiment which was first advertised on February 7th 2020 and updated lastly on September 14th 2022. 70 participants are sought from one facility."

Answered by AI

What pathologies have been addressed with Hematopoietic Cell Transplantation?

"One form of treatment for bone marrow transplantation is Hematopoietic Cell Transplantation. This medical intervention has proven to be successful in aiding the recovery process from leukemia, infection, and lung cancers as well."

Answered by AI

Has Hematopoietic Cell Transplantation been given clearance by the FDA?

"Our team at Power assessed the safety of Hematopoietic Cell Transplantation as a 2 due to data that suggests it is secure, though no evidence has been found confirming its efficacy."

Answered by AI

Are participants of a certain age able to access this research initiative?

"The parameters for participant enrolment in this research project stipulate that the youngest participants must be 12 years old, while noone older than 60 may participate."

Answered by AI

Are there any related investigations into Hematopoietic Cell Transplantation?

"Currently, 1068 Hematopoietic Cell Transplantation trials are open and 198 of them have reached Phase 3. Of these, many are located in Philadelphia - but an impressive 31000 other sites offer this kind of trial too."

Answered by AI

Who meets the qualifications to partake in this clinical research?

"This clinical trial requires 70 participants ranging in age from 12 to 60 who have been previously diagnosed with acute lymphocytic leukemia (L1). In addition, they must be in either second or third complete remission and present chemosensitive active disease."

Answered by AI

Are researchers actively seeking out participants for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical study is accepting applications from patients since February 7th 2020 and it has most recently been updated on September 14th 2022. 70 people are required for the trial which will occur in a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia
2020. "Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04262843.
~16 spots leftby Aug 2025
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