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Alkylating agents

IMRT + Chemotherapy + Stem Cell Transplant for Leukemia

Phase 1 & 2
Waitlist Available
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 2 years post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is giving IMRT with chemotherapy to patients with relapsed or refractory ALL or AML before a donor stem cell transplant. The aim is to find out the side effects of this treatment and the best dose of IMRT to give, as well as how well the IMRT and chemotherapy work in treating patients.

Who is the study for?
This trial is for patients with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) who have not responded to initial treatments. They must have a suitable sibling or matched unrelated donor for stem cell transplant, good kidney and liver function, acceptable heart health, and no previous bone marrow transplants. Pregnant individuals cannot participate.
What is being tested?
The study tests whether using intensity-modulated radiation therapy (IMRT) with chemotherapy drugs etoposide and cyclophosphamide before a stem cell transplant from a donor can effectively treat relapsed/refractory ALL or AML without causing the immune system to reject the new cells.
What are the potential side effects?
Potential side effects include damage to organs near treated areas due to radiation, increased risk of infections after transplantation, reactions related to chemotherapy such as nausea and hair loss, and possible complications from the body's reaction against donor cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)
Secondary study objectives
Acute and chronic graft-versus-host disease (Phase II)
Infection (Phase II)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Level 9: 2000cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental Treatment7 Interventions
200cGy BID Day 1-5. Total dose 2000Gy.
Group II: Level 8: 1900cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental Treatment7 Interventions
190cGy BID Day 1-5. Total dose 1900Gy.
Group III: Level 7: 1800cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental Treatment7 Interventions
180cGy BID Day 1-5. Total dose 1800Gy.
Group IV: Level 6: 1700cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental Treatment7 Interventions
170cGy BID Day 1-5. Total dose 1700Gy.
Group V: Level 5: 1600cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental Treatment7 Interventions
160cGy BID Day 1-5. Total dose 1600Gy.
Group VI: Level 4: 1500cGy limited dose to liver, brain 1200cGyExperimental Treatment7 Interventions
150cGy BID Day 1-5. Total dose 1500Gy.
Group VII: Level 3: 1500cGy limited dose to ribs, sternum, liver, brain 1200cGyExperimental Treatment7 Interventions
150cGy BID Day 1-5. Total dose 1500Gy.
Group VIII: Level 2: 1350cGyExperimental Treatment7 Interventions
150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
Group IX: Level 1: 1200cGyExperimental Treatment7 Interventions
150cGy BID x Days 1-4. Total dose 1200cGy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
etoposide
1994
Completed Phase 3
~9300
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
tomotherapy
2014
N/A
~190
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
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,554 Total Patients Enrolled
91 Trials studying Leukemia
5,223 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,066 Total Patients Enrolled
1,536 Trials studying Leukemia
385,538 Patients Enrolled for Leukemia
Anthony S. Stein, MDStudy ChairCity of Hope Medical Center
3 Previous Clinical Trials
201 Total Patients Enrolled
3 Trials studying Leukemia
201 Patients Enrolled for Leukemia

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00576979 — Phase 1 & 2
Leukemia Research Study Groups: Level 1: 1200cGy, Level 2: 1350cGy, Level 3: 1500cGy limited dose to ribs, sternum, liver, brain 1200cGy, Level 4: 1500cGy limited dose to liver, brain 1200cGy, Level 5: 1600cGy limited dose to liver, porta-hepatic, brain 1200cGy, Level 6: 1700cGy limited dose to liver, porta-hepatic, brain 1200cGy, Level 7: 1800cGy limited dose to liver, porta-hepatic, brain 1200cGy, Level 8: 1900cGy limited dose to liver, porta-hepatic, brain 1200cGy, Level 9: 2000cGy limited dose to liver, porta-hepatic, brain 1200cGy
Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00576979 — Phase 1 & 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00576979 — Phase 1 & 2
~3 spots leftby Dec 2025
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