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Chemotherapy

GVHD-Reduction Strategies for Blood Cancers

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
Must not have
Patients who have received previous myeloablative allogeneic or autologous transplantation.
DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection. Test must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits (serological and/or nucleic acid amplification test [NAT] and/or other approved testing) in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone marrow transplant before.
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I am a donor without HIV, HTLV, active hepatitis B or C.
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My kidney function is reduced, but my creatinine clearance is above 60 ml/min.
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I have been told I have less than 12 months to live due to a condition other than my leukemia or MDS.
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I weigh less than 100 kg and have a donor who is a close genetic match.
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I am allergic to tacrolimus or methotrexate.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Graft versus host disease (GVHD)-free relapse-free survival (RFS)
Secondary study objectives
Graft rejection or irreversible graft failure (> 14 days duration)
Incidence of chronic GVHD
Overall survival (OS)
+1 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
Echocardiography
2013
Completed Phase 4
~11580
Fludarabine
2012
Completed Phase 4
~1860
Methotrexate
2019
Completed Phase 4
~4400
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Thiotepa
2008
Completed Phase 3
~2120
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Biospecimen Collection
2004
Completed Phase 3
~2020
Sirolimus
2013
Completed Phase 4
~2750
Tacrolimus
2019
Completed Phase 4
~5510
Cyclophosphamide
2010
Completed Phase 4
~2320
Total-Body Irradiation
1997
Completed Phase 3
~1180
Cyclosporine
1997
Completed Phase 3
~1820
Busulfan
2008
Completed Phase 4
~1710

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,243 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,880 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
563 Previous Clinical Trials
1,342,291 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
~38 spots leftby Dec 2026
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