Trial comparing treatments 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?
This is an investigational combination of two chemotherapy drugs being studied to help prepare the body for a stem cell transplant in people with acute myelogenous leukemia. It is designed to lower the number of existing blood cells and suppress the immune system to make room for new stem cells.
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 study compares a new drug combination with the standard one to see which better prevents graft‑versus‑host disease and to evaluate their safety.
- Who it's for
- Adults with blood cancers such as leukemia, lymphoma, or myelodysplastic syndromes who are receiving a peripheral blood stem cell transplant from a mismatched unrelated donor.
- What's involved
- Participants will receive either the standard or the new drug combination after transplant, attend routine follow‑up visits, complete surveys about their well‑being, and provide blood and stool samples.
- Time commitment
- The study lasts until the end of the transplant follow‑up period, with several scheduled visits for check‑ups and tests after the transplant.
- 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
- 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)
- Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35
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
- 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...
- AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease.
- 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).
- 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
- 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.