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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post transplant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)

Secondary outcome measures

Acute and chronic graft-versus-host disease (Phase II)

Infection (Phase II)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,409 Total Patients Enrolled

82 Trials studying Leukemia

4,933 Patients Enrolled for Leukemia

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,102 Total Patients Enrolled

1,512 Trials studying Leukemia

384,631 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

Frequently Asked Questions

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

Has research been conducted previously on intensity-modulated radiation therapy?

"Currently, there are 204 Phase 3 studies for intensity-modulated radiation therapy (IMRT) with a total of 993 clinical trials currently underway. Philadelphia, Pennsylvania is the main hub for these experiments; however, IMRT investigations can be found at 36293 locations around the world."

Answered by AI

Is this research undertaking still open to participants?

"Per the information present on clinicaltrials.gov, this specific study is no longer recruiting participants as of 3/17/2022 despite having been first posted 4/3/2008. However, prospective patients may still be able to join a trial due to there being 2463 other studies seeking enrolment currently."

Answered by AI

To what extent is this research trial being utilized to benefit those affected?

"Unfortunately, this investigation has concluded its recruitment phase. It was initially posted on March 4th 2008 and had its latest update on March 17th 2022. Patients with leukemia have 1,470 active trials to choose from while those seeking intensity-modulated radiation therapy can select among 993 studies that are actively recruiting participants."

Answered by AI

Does the enrollment criteria for this experiment encompass individuals beyond forty years of age?

"This medical trial requires that enrollees are between 7 and 55 years old. Other clinical trials have been created for those under the age of 18 (800) as well as people older than 65 (1919)."

Answered by AI

What criteria must be met to gain access to the clinical trial?

"This clinical trial is specifically seeking 87 individuals between the ages of 7 and 55 who have been diagnosed with leukemia."

Answered by AI

To what medical conditions is intensity-modulated radiation therapy typically applied?

"Intensity-modulated radiation therapy has been found to effectively treat leukemia and other malignancies such as prostate cancer, lung cancers, and sclc."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

2008. "Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00576979.

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