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Compares treatment options for AML (Acute Myelogenous Leukemia)
Official title A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06859424
What this study is testing
What is Conditioning Regimen A?
Conditioning Regimen A is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for aml (acute myelogenous leukemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 66
You may be able to join if
- , MAC RECIPIENTS:
- Age 18 to \< 66 years (chemotherapy-based conditioning) or \< 61 years (TBI-based conditioning) at the time of signing informed consent
- Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional...
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)
You likely can't join if
- Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
- Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- people with a prior allogeneic transplant
- people with an autologous transplant within the past 3 months
- people who are breastfeeding or pregnant
- Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
See the full eligibility criteria
- , MAC RECIPIENTS:
- Age 18 to \< 66 years (chemotherapy-based conditioning) or \< 61 years (TBI-based conditioning) at the time of signing informed consent
- Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)
- Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35
- Product planned for infusion is MMUD T-cell replete PBSC as allograft
- HCT-CI \< 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with...
- One of the following diagnoses:
- AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45...
- Patients with MDS with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% vs 5-10% blasts in MDS). Documentation of...
- Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results
- Estimated creatinine clearance ≥ 45mL/min calculated by equation
- Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results
- Liver function acceptable per local institutional guidelines
- KPS of ≥ 70% (Appendix I - Performance Status) , RIC/NMA RECIPIENTS:
- Age ≥ 18 years at the time of signing informed consent
- Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Planned NMA/RIC regimen (see
- Table 9 in Section 7.4 for allowed NMA/RIC regimens)
- Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35
- Product planned for infusion is MMUD T-cell replete PBSC allograft
- One of the following diagnoses:
- Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \< 5% blasts in the bone marrow. Documentation of bone marrow assessment will be...
- Patients with MDS with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% vs 5-10% blasts in MDS.) Documentation of...
- Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.
- Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS/myeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no...
- Patients with lymphoma with chemosensitive disease at the time of transplantation.
- Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.
- Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure
- Estimated creatinine clearance ≥ 45mL/min calculated by equation
- Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results
- Liver function acceptable per local institutional guidelines
- KPS of ≥ 60% (Appendix I - Performance Status)
- Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
- Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- people with a prior allogeneic transplant
- people with an autologous transplant within the past 3 months
- people who are breastfeeding or pregnant
- Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
- Concurrent enrollment on a GVHD prevention clinical trial
- people who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant
- Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Palo Alto, California, United States
- Miami, Florida, United States
- Westwood, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 66 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Palo Alto, California, United States; Miami, Florida, United States; Westwood, Kansas, United States; Boston, Massachusetts, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.