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Stem Cell Transplantation for Leukemia (ACCESS Trial)
Phase 2
Recruiting
Led By Steven Devine, MD
Research Sponsored by Center for International Blood and Marrow Transplant Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Donor: Must agree to donate PBSC (or BM for stratum 3)
Stratum 3 Recipient: KPS or Lansky performance score ≥ 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-hct
Awards & highlights
ACCESS Trial Summary
This trial will study the use of HCT with MMUD in patients with hematologic malignancies, using PTCy, tacrolimus, and MMF for GVHD prophylaxis.
Who is the study for?
Adults aged 18-66 with various types of leukemia or lymphoma, fit for stem cell transplant using cells from a partially matched unrelated donor. They must have good heart, kidney, and lung function, an acceptable performance status score indicating they can carry out daily activities, and no severe infections or recent transplants. Pregnant women and those unable to consent are excluded.Check my eligibility
What is being tested?
The trial is testing hematopoietic cell transplantation (HCT) from HLA-mismatched unrelated donors in adults (using peripheral blood stem cells) and children (using bone marrow). It aims to prevent graft versus host disease using post-transplant cyclophosphamide along with other medications.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion of stem cells, damage to organs due to chemotherapy drugs like busulfan and cyclophosphamide, increased risk of infections after the transplant, mouth sores from mucositis caused by chemotherapy/radiation therapy.
ACCESS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to donate stem cells or bone marrow.
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My physical ability score is 70% or higher.
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I have leukemia that responds to chemotherapy and am getting a transplant.
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My heart's left ventricle pumps well, with an efficiency of 50% or more.
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I have leukemia with less than 5% blasts in my bone marrow and no disease outside the marrow.
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I have AML, ALL, or another acute leukemia in remission with minimal marrow involvement.
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My heart pumps well and I don't have heart failure.
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My heart's pumping ability is good.
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My leukemia is in its first remission or later, with minimal signs in my marrow and no signs outside the marrow.
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My donor is not related to me and matches me closely in tissue type.
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I am a donor between 18 and 35 years old.
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My kidney function, measured by GFR, is normal or only mildly reduced.
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My lung function tests show more than half the normal capacity.
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My lymphoma is responding to chemotherapy and is in partial remission.
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My kidneys are functioning well.
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I am mostly able to care for myself and carry out daily activities.
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My MDS has less than 10% blasts in the bone marrow and no blasts in my blood.
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My condition is MDS with less than 10% bone marrow blasts and no blasts in my blood.
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I am between 18 and 66 years old and will undergo chemotherapy, or between 18 and 61 for radiation therapy.
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My kidneys are functioning well, with a creatinine clearance over 60 mL/min.
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My donor's HLA types have been thoroughly tested.
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My lung function tests show more than half the normal capacity.
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My leukemia is in remission with minimal signs in my marrow and no signs outside the marrow.
Select...
My lung function tests are at least 50% of the expected value.
Select...
My AML is in its first remission or beyond, with minimal signs in my marrow and no signs outside the marrow.
ACCESS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Cytomegalovirus Infections
Cumulative incidence of acute GVHD
Cumulative incidence of chronic GVHD
+17 moreACCESS Trial Design
7Treatment groups
Experimental Treatment
Group I: Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)Experimental Treatment8 Interventions
Patients receive:
Cyclophosphamide (100 mg/kg total dose) IV on days -5 and -4
TBI (1200 cGy total dose) on days -3, -2 and -1
Patients receive a BM graft infusion from a mismatched unrelated donor on Day 0.
Group II: Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT)Experimental Treatment8 Interventions
Patients receive:
Busulfan (dosed by age and weight per institutional standards to target goal pharmacokinetic (PK) in range noted in protocol.) on days -6 to -3
Cyclophosphamide (100 mg/kg total dose) IV on days -2 and -1
Patients receive a bone marrow (BM) graft infusion from a mismatched unrelated donor on Day 0.
Group III: Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)Experimental Treatment9 Interventions
Patients receive:
Fludarabine (150 mg/m2 total dose) IV on days -6 to -2
Cyclophosphamide (29-50 mg/kg) IV on days -6 and -5
TBI (200 cGy) on day -1
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.
Group IV: Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)Experimental Treatment8 Interventions
Patients receive:
Fludarabine (120-180 mg/m2 total dose) IV on days -7 to -3
Melphalan (100-140 mg/m2) IV on day -1
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.
Group V: Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)Experimental Treatment8 Interventions
Patients receive:
Fludarabine (120-180 mg/m2 total dose) IV on days -6 to -2
Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.
Group VI: Regimen B (MAC: Fludarabine and TBI; PBSC HCT)Experimental Treatment8 Interventions
Patients receive:
Fludarabine (90 mg/m2 total dose) IV on days -7 to -5
Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1
Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.
Group VII: Regimen A (MAC: busulfan and fludarabine, PBSC HCT)Experimental Treatment8 Interventions
Patients receive:
Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3
Fludarabine (150 mg/m2 total dose) IV on days -6 to -2
Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Melphalan
2008
Completed Phase 3
~1500
Mesna
2003
Completed Phase 2
~1380
Tacrolimus
2011
Completed Phase 4
~4740
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
Center for International Blood and Marrow Transplant ResearchLead Sponsor
38 Previous Clinical Trials
200,193,130 Total Patients Enrolled
National Marrow Donor ProgramOTHER
60 Previous Clinical Trials
202,260 Total Patients Enrolled
Steven Devine, MDPrincipal InvestigatorNMDP/Be The Match
4 Previous Clinical Trials
280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to donate stem cells or bone marrow.My physical ability score is 70% or higher.I am planned to receive a high-dose chemotherapy regimen.I had a stem cell transplant using my own cells within the last 3 months.I have leukemia that responds to chemotherapy and am getting a transplant.I am scheduled to receive a stem cell transplant using cells from blood.My lymphoma responds to chemotherapy and I am about to undergo a transplant.My heart's left ventricle pumps well, with an efficiency of 50% or more.I have leukemia with less than 5% blasts in my bone marrow and no disease outside the marrow.I have AML, ALL, or another acute leukemia in remission with minimal marrow involvement.I am scheduled for a high-dose chemotherapy treatment.My heart pumps well and I don't have heart failure.My heart's pumping ability is good.I am over 18 and have signed the informed consent.I am under 35 and have a partially matched donor for a transplant.My physical condition allows me to do some daily activities without help.I am between 1 and 21 years old.My leukemia is in its first remission or later, with minimal signs in my marrow and no signs outside the marrow.My liver function tests are within the required range.My legal guardian has agreed to my participation if I'm under 18.My donor is not related to me and matches me closely in tissue type.I am a donor between 18 and 35 years old.My liver function meets my hospital's guidelines.I am under 35 and have a partially matched donor for a transplant.I am not pregnant or breastfeeding.I meet the health requirements for stem cell or bone marrow donation.I am 18 or older and can legally consent to participate.I am scheduled to receive a stem cell transplant.I am 18 or older and can legally consent to participate.My donor cannot or will not donate.My condition is myelofibrosis, either primary or due to another blood disorder.My kidney function, measured by GFR, is normal or only mildly reduced.I am planned for a mild intensity stem cell transplant.My lung function tests show more than half the normal capacity.My lymphoma is responding to chemotherapy and is in partial remission.My kidneys are functioning well.I am under 35 and have a specific partial match for a bone marrow transplant.My liver functions are within normal range according to my doctor's standards.I am mostly able to care for myself and carry out daily activities.My MDS has less than 10% blasts in the bone marrow and no blasts in my blood.My condition is MDS with less than 10% bone marrow blasts and no blasts in my blood.I am between 18 and 66 years old and will undergo chemotherapy, or between 18 and 61 for radiation therapy.I am scheduled to receive a bone marrow infusion.I have a donor who matches me closely for a transplant.I am undergoing treatment to lower my body's reaction to a transplant.I am 18 or older and can legally consent to participate.I do not have an uncontrolled infection before my transplant.My kidneys are functioning well, with a creatinine clearance over 60 mL/min.My donor's HLA types have been thoroughly tested.My MDS condition has less than 10% blasts in the bone marrow and no circulating blasts.My lung function tests show more than half the normal capacity.My leukemia is in remission with minimal signs in my marrow and no signs outside the marrow.My lung function tests are at least 50% of the expected value.I have antibodies against the donor's mismatched HLA.My AML is in its first remission or beyond, with minimal signs in my marrow and no signs outside the marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen A (MAC: busulfan and fludarabine, PBSC HCT)
- Group 2: Regimen B (MAC: Fludarabine and TBI; PBSC HCT)
- Group 3: Regimen C (RIC: Fludarabine and Busulfan; PBSC HCT)
- Group 4: Regimen D (RIC: Fludarabine and Melphalan; PBSC HCT)
- Group 5: Regimen E (NMA: Fludarabine, Cyclophosphamide, TBI; PBSC HCT)
- Group 6: Regimen F (MAC: Busulfan and Cyclophosphamide; BM HCT)
- Group 7: Regimen G (MAC: Cyclophosphamide and TBI; BM HCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what cases is Bone Marrow Hematopoietic Stem Cell Transplantation a viable therapeutic option?
"Bone Marrow Hematopoietic Stem Cell Transplantation has proven effectiveness in the treatment of dermatitis, atopic, multiple sclerosis, leukemia, myelocytic-acute and psoriasis."
Answered by AI
Are there any opportunities to join this scientific experiment?
"Per records on clinicaltrials.gov, this medical research endeavour is currently recruiting patients to take part. This trial was initially made available on September 30th 2021 and has been recently modified and updated as of November 14th 2022."
Answered by AI
What is the total sample size of this medical experiment?
"This trial requires 180 eligible participants, with multiple sites such as Northwestern University in Chicago, IL and TriStar Medical Group Children's Specialists in Nashville, TN ready to accept volunteers."
Answered by AI
Are there extensive facilities offering this clinical trial within the United States?
"Patients can be recruited from Northwestern University in Chicago, IL; TriStar Medical Group Children's Specialists in Nashville, TN; St. David's South Austin Medical Center in Austin, TX and other thirty-three clinical sites across the nation."
Answered by AI
Can you provide a comprehensive overview of the research conducted so far regarding Bone Marrow Hematopoietic Stem Cell Transplantation?
"In 1997, City of Hope Comprehensive Cancer Center pioneered research on Bone Marrow Hematopoietic Stem Cell Transplantation. Since then, 2000 trials have been successfully conducted and 1074 are currently ongoing - a great number in the Chicago area."
Answered by AI
Has the FDA sanctioned Bone Marrow Hematopoietic Stem Cell Transplantation?
"As a Phase 2 trial, we at Power rate the safety of Bone Marrow Hematopoietic Stem Cell Transplantation with a score of two due to existing data that supports its security but lacks evidence for efficacy."
Answered by AI
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