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Chemotherapy

GVHD-Reduction Strategies for Blood Cancers

Q: What other research endeavors have been conducted regarding Peripheral Blood Stem Cell?

The development of Peripheral Blood Stem Cell was first investigated in 1997 at City of Hope Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center. Since then, there have been 2588 clinical trials concluded and 1239 that are still actively recruiting participants - mostly located around Seattle, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>.

Q: Are there opportunities for recruitment into this research endeavor?

Affirmative. Information hosted on clinicaltrials.gov verifies that this medical study is currently recruiting; the trial was first registered on November 19th 2019 and has since been updated as recently as October 26th 2022. The research requires around 120 participants to be recruited from 3 separate locations.

Q: Is older age a limitation to enrolling in this experiment?

This clinical trial is limited to patients between the age of 1 year and 60. There are 1200 studies conducted on persons younger than 18 years old, while 4450 trials have been concluded with participants older than 65.

Phase 2

Recruiting

Led By Marie Bleakley

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens

Patient age 1-60 years old (inclusive) at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

This trial is testing two different ways to reduce the risk of graft versus host disease.

Who is the study for?

This trial is for patients with acute leukemia or MDS in remission, aged 1-60, who have a matched donor for stem cell transplant. They must be vaccinated against COVID-19 and cannot participate if they weigh over 100 kg, are HIV positive, have significant organ dysfunction like kidney failure or heart issues, are pregnant/breastfeeding, unwilling to use birth control post-transplant, or have uncontrolled infections.Check my eligibility

What is being tested?

The trial tests two strategies to reduce graft versus host disease after a donor peripheral blood stem cell transplant. Patients receive chemotherapy and total-body irradiation before the transplant to stop cancer growth and prepare their body to accept the donor's healthy stem cells.See study design

What are the potential side effects?

Potential side effects include reactions from the immune system attacking normal tissues (graft versus host disease), complications from chemotherapy such as nausea and hair loss, risks associated with radiation exposure like fatigue and skin changes, and increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 50 years old and eligible for a specific treatment plan.

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I am between 1 and 60 years old.

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I have a donor who matches my HLA type for a stem cell donation.

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My leukemia is in remission with less than 5% marrow blasts.

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My donor is a perfect match for me based on detailed genetic testing.

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I have MDS with a history of high blast counts and received treatment within the last 3 months.

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I am between 1 and 60 years old and eligible for a specific chemotherapy regimen.

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I am a candidate for a specific stem cell transplant due to my diagnosis.

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My AML is in remission with less than 5% marrow blasts.

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I am willing to donate my stem cells.

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I am 18 years old or older.

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My leukemia is in remission with less than 5% of cancer cells in my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 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

Graft versus host disease (GVHD)-free relapse-free survival (RFS)

Secondary outcome measures

Graft rejection or irreversible graft failure (> 14 days duration)

Incidence of chronic GVHD

Overall survival (OS)

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm D2 (busulfan, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021]Experimental Treatment11 Interventions

Patients receive busulfan IV over 180 minutes on days -8 to -5, cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Group II: Arm D1 (TBI, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021]Experimental Treatment11 Interventions

Patients undergo TBI BID on days -6 to -4, and receive cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Group III: Arm C2 (busulfan, PTCy, tacrolimus)Experimental Treatment11 Interventions

Patients receive fludarabine IV over 30 to 60 minutes on days -5 to -2, busulfan IV over 180 minutes on days -5 to -2, PBSC IV on day 0, cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Group IV: Arm C1 (TBI, PTCy, tacrolimus)Experimental Treatment10 Interventions

Patients undergo TBI BID on days -4 to -2 or -3 to -1, and receive PBSC IV on day 0. Patients also receive cyclophosphamide IV over 1 to 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Group V: Arm A2 (busulfan, TnD)Experimental Treatment11 Interventions

Patients receive fludarabine IV over 30 to 60 minutes on days -6 to -2, busulfan IV over 180 minutes on days -5 to -2, and undergo TBI BID on day -1. Patients also receive tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Group VI: Arm A1 (TBI, TnD)Experimental Treatment12 Interventions

Patients undergo TBI BID on days -10 to -7, and receive thiotepa IV over 3 hours on days -6 and -5, fludarabine IV over 30 to 60 minutes on days -6 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, CD34+ enriched CD45RA-depleted donor T-lymphocytes IV on day 0, and methotrexate IV on days 1, 3, 6, and 11. If there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). Patients also undergo bone marrow aspiration/biopsy, ECHO or MUGA scan, and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thiotepa

2008

Completed Phase 3

~2210

Biospecimen Collection

2004

Completed Phase 2

~1700

Tacrolimus

2011

Completed Phase 4

~4740

Cyclophosphamide

1995

Completed Phase 3

~3770

Methotrexate

2013

Completed Phase 4

~3800

Fludarabine

2012

Completed Phase 3

~1100

Sirolimus

2013

Completed Phase 4

~2750

Echocardiography

2013

Completed Phase 4

~11670

Total-Body Irradiation

1997

Completed Phase 3

~1180

Cyclosporine

1997

Completed Phase 3

~1830

Busulfan

2008

Completed Phase 3

~1120

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,252 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,734 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,275 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03970096 — Phase 2

Acute Leukemia Research Study Groups: Arm C2 (busulfan, PTCy, tacrolimus), Arm A2 (busulfan, TnD), Arm C1 (TBI, PTCy, tacrolimus), Arm D1 (TBI, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021], Arm D2 (busulfan, tacrolimus, methotrexate) [DISCONTINUED NOVEMBER 2021], Arm A1 (TBI, TnD)

Acute Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03970096 — Phase 2

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03970096 — Phase 2

Frequently Asked Questions

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

To what extent is Peripheral Blood Stem Cell employed for therapeutic purposes?

"Peripheral Blood Stem Cell (PBSC) is frequently used in transplantation and can be a viable option for treating small cell lung cancer, organ replacement surgeries, and atopic dermatitis."

Answered by AI

To what extent is Peripheral Blood Stem Cell a threat to human health?

"The safety level of Peripheral Blood Stem Cell was estimated to be 2, as there is clinical evidence indicating its security but no data confirming efficacy."

Answered by AI

What is the upper limit of participants involved in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov platform, this research inquiry is currently enrolling participants. The study was initially announced on November 19th 2019 and edited as recently as October 26th 2022; 120 individuals are needed across 3 different medical sites."

Answered by AI

May I be considered as a participant in this experiment?

"This medical trial is recruiting a sample size of 120 persons with acute leukemia, aged 1-60 years old. In addition to meeting the age requirements, prospective participants must satisfy multiple criteria; these include possessing an HLA matched related or unrelated donor capable of donating PBSC and being in first or subsequent morphological remission (< 5% marrow blasts by morphology). Moreover, for those under 50, they are eligible for TBI-based conditioning regimens."

Answered by AI

What other research endeavors have been conducted regarding Peripheral Blood Stem Cell?

"The development of Peripheral Blood Stem Cell was first investigated in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been 2588 clinical trials concluded and 1239 that are still actively recruiting participants - mostly located around Seattle, Washington."

Answered by AI

Are there opportunities for recruitment into this research endeavor?

"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical study is currently recruiting; the trial was first registered on November 19th 2019 and has since been updated as recently as October 26th 2022. The research requires around 120 participants to be recruited from 3 separate locations."

Answered by AI

Is older age a limitation to enrolling in this experiment?

"This clinical trial is limited to patients between the age of 1 year and 60. There are 1200 studies conducted on persons younger than 18 years old, while 4450 trials have been concluded with participants older than 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

2019. "Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970096.

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