New transplant combo aims to boost survival in blood cancer patients
NCT ID NCT07214688
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a new combination of chemotherapy, radiation, and immune-suppressing drugs for people aged 18-65 with blood cancers who need a stem cell transplant. The goal is to see if this regimen improves survival one year after transplant. About 209 participants will receive the treatment at multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fludarabine, total body irradiation, cyclophosphamide, tacrolimus
- What this could lead to
- If successful, this could offer a safer and more effective stem cell transplant regimen for people with blood cancers, potentially improving survival rates.
- What could go wrong
- This is a phase 2 trial, so it's still early. The regimen may not improve survival and could cause serious side effects like infection or graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 209 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ages 18-65 years. * Patients with a diagnosis of one of the following hematologic malignancies: * Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow; * Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest; * Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood; * Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria). * Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs. * Patients with a Karnofsky performance status (KPS) of ≥60%. * Patients with adequate organ function defined by: * Cardiac: LVEF ≥50% * Pulmonary: DLCO ≥50% of predicted * Hepatic: Bilirubin ≤1.5x ULN, ALT/AST ≤2.5x ULN * Renal: Creatinine clearance ≥50 mL/min * All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT), the FDA, and other expert bodies. * For Male Participants: ○ Male participants must use effective contraception for at least 12 months after transplant, and longer if receiving immunosuppressive or cytotoxic medications. Chemotherapy and radiation can cause DNA damage to sperm, and even if fertility returns, mutations may persist for months. In cases where drugs such as mycophenolate mofetil (MMF) or lenalidomide are used, FDA guidance requires contraception for at least 90 days after discontinuation. Sperm cryopreservation should be offered prior to conditioning. Participants must avoid fathering a child during this time frame.15-17 * For Female Participants: * Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy. For drugs such as MMF, sirolimus, or ruxolitinib, contraception must continue for 3 months after the last dose. * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.15-17 * Patients with a suitable donor for allogeneic stem cell transplant defined by: * Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation; * Unrelated donors at \>7/8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor Program criteria; or Related Haploidentical donors willing to donate PBSC or BM and meeting criteria for donation. * Patients who are able to comply with follow-up visits and treatment plans. * Patients who are able to give informed consent. Exclusion Criteria: * Hematopoietic cell transplantation comorbidity index above 3. * Patients with a Karnofsky performance status (KPS) of \<60%. * Patients with active infections or other contraindications for allogeneic stem cell transplant. * Patients who are unable or unwilling to give informed consent. * Patients who have received a prior allogeneic transplant. * Patients who are unable to comply with follow-up visits and treatment plans.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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John Theurer Cancer Center at Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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John Theurer Cancer Center at Jersey Shore University Medical Center
NOT_YET_RECRUITINGNeptune City, New Jersey, 07753, United States
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
NOT_YET_RECRUITINGWashington D.C., District of Columbia, 20007, United States
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