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Alkylating agents

Total Marrow and Lymphoid Irradiation and Chemotherapy for Acute Leukemia

Phase 2
Recruiting
Led By Anthony Stein
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the safety and efficacy of total marrow and lymphoid irradiation given before a donor stem cell transplant in treating patients with high-risk acute lymphocytic leukemia or acute myeloid leukemia who have failed previous therapy.

Who is the study for?
This trial is for adults with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who haven't responded to previous treatments. Participants need a compatible bone marrow donor, good physical function, and normal organ function tests. They must not be pregnant, agree to use contraception, and can't have had certain prior treatments that would conflict with the trial.Check my eligibility
What is being tested?
The study is testing total marrow and lymphoid irradiation (TMLI) combined with etoposide and cyclophosphamide chemotherapy before receiving a stem cell transplant from a donor. TMLI uses advanced imaging to target radiation at the bone marrow while sparing other organs, aiming to prepare patients better for transplantation.See study design
What are the potential side effects?
Potential side effects include damage to organs near the irradiated area, typical chemotherapy-related issues like nausea, hair loss, fatigue, increased risk of infections due to low blood counts, mouth sores, and potential complications from the stem cell transplant.

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 toxicity, scored on both the Bearman Scale and National Cancer Institute Common Terminology Criteria version 4.03 (Safety lead-in segment)
PFS
Secondary outcome measures
Complete response (CR) proportion
Incidence of aGVHD of grades 3-4, graded according to the Consensus Grading
Incidence of acute graft versus host disease GVHD (aGVHD) of grades 2-4, graded according to the Consensus Grading
+6 more

Side effects data

From 2014 Phase 3 trial • 25 Patients • NCT00322101
55%
Mucositis
45%
Infection
18%
severe diarrhea due to gut GVHD
9%
Thrombotic Microangiopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Myeloablative Regimen)
Arm I (Nonmyeloablative Regimen)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (TMLI, chemotherapy)Experimental Treatment5 Interventions
Patients undergo image guided TMLI on days -9 to -5, receive etoposide IV on day -4 and cyclophosphamide IV on day -2, and undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
etoposide
1994
Completed Phase 3
~9300
total marrow irradiation
2004
Completed Phase 2
~80
cyclophosphamide
1994
Completed Phase 3
~8140
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
allogeneic bone marrow transplantation
2005
Completed Phase 3
~5000

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,529 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,663 Total Patients Enrolled
Anthony SteinPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02094794 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (TMLI, chemotherapy)
Acute Myeloid Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02094794 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02094794 — Phase 2

Frequently Asked Questions

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

Am I permitted to participate in this research?

"Potential participants in this clinical trial must have a diagnosis of leukemia and be between the ages 16-60. Up to 87 individuals will be accepted for the study."

Answered by AI

What is the current capacity for participants in this medical experiment?

"Affirmative. As per the information available on clinicaltrials.gov, this research endeavour is currently enrolling participants and was first launched in May 12th 2014 with an update made on 19th of May 2022. The team needs a total of 87 patients from 1 site to participate in the trial."

Answered by AI

Are there still opportunities to partake in this clinical assessment?

"As per the details on clinicaltrials.gov, this investigation is actively seeking participants. Initial information about the study was posted online at May 12th 2014 and the most recent update came out on May 19th 2022."

Answered by AI

What medical conditions are typically treated with allogeneic hematopoietic stem cell transplantation?

"Allogeneic hematopoietic stem cell transplantation can offer relief from leukemia, prostate cancer, and lung cancers."

Answered by AI

Are subjects of 45 years and above eligible to partake in this investigation?

"As outlined by the study's criteria, individuals that are of age 16 and above yet below 60 qualify for enrolment."

Answered by AI

Have researchers conducted prior experiments on the use of allogeneic hematopoietic stem cell transplantation?

"Presently, there are 993 extant investigations into allogeneic hematopoietic stem cell transplantation with 204 of those being in Phase 3. Although most research is taking place in Philadelphia, Pennsylvania, trials for this treatment abound at 36293 different sites worldwide."

Answered by AI

What are the attendant dangers of undergoing allogeneic hematopoietic stem cell transplantation?

"The safety of allogeneic hematopoietic stem cell transplantation is rated as a 2 on the 1-3 scale. This indicates that there have been some studies which show evidence for its security, but no trials to prove efficacy as it is still in Phase 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML
2014. "Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02094794.
~6 spots leftby Feb 2025
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