allogeneic hematopoietic stem cell transplantation for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CAAcute Myeloid Leukemia+9 Moreallogeneic hematopoietic stem cell transplantation - Procedure
Eligibility
16 - 60
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Acute Myeloid Leukemia (AML)
  • Childhood Acute Myeloid Leukemia (AML)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Acute Promyelocytic Leukemia (APL)
  • Acute Myeloid Leukemia (AML) With t(16;16)(p13;q22)
  • Acute Lymphoblastic Leukemia (ALL)
  • Childhood Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 5 years

Year 5
Time to relapse/progression
Year 5
NRM
Day 30
Complete response (CR) proportion
Year 5
OS
Year 2
PFS
Day 100
Incidence of infection
Day 30
Incidence of toxicity, scored on both the Bearman Scale and National Cancer Institute Common Terminology Criteria version 4.03 (Safety lead-in segment)
Up to 5 years
Incidence of chronic GVHD, scored according to National Institute of Health Consensus staging
Day 100
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
Incidence of toxicities, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Arm II (Myeloablative Regimen)
55%Mucositis
45%Infection
18%severe diarrhea due to gut GVHD
9%Thrombotic Microangiopathy
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00322101) in the Arm II (Myeloablative Regimen) ARM group. Side effects include: Mucositis with 55%, Infection with 45%, severe diarrhea due to gut GVHD with 18%, Thrombotic Microangiopathy with 9%.

Trial Design

1 Treatment Group

Treatment (TMLI, chemotherapy)
1 of 1

Experimental Treatment

87 Total Participants · 1 Treatment Group

Primary Treatment: allogeneic hematopoietic stem cell transplantation · No Placebo Group · Phase 2

Treatment (TMLI, chemotherapy)Experimental Group · 5 Interventions: etoposide, total marrow irradiation, cyclophosphamide, allogeneic hematopoietic stem cell transplantation, allogeneic bone marrow transplantation · Intervention Types: Drug, Radiation, Drug, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
total marrow irradiation
2004
Completed Phase 2
~80
Cyclophosphamide
FDA approved
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~860
allogeneic bone marrow transplantation
2005
Completed Phase 3
~5000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,155 Previous Clinical Trials
41,163,493 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
524 Previous Clinical Trials
2,249,388 Total Patients Enrolled
Anthony SteinPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 16 - 60 · All Participants · 15 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"The safety of allogeneic hematopoietic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.