New drug combo may make bone marrow transplants safer for blood cancer patients
NCT ID NCT02996773
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested replacing the standard drug cyclophosphamide with bendamustine after a half-matched bone marrow transplant in 50 patients with various blood cancers. The goal was to see if this change could reduce side effects like graft-versus-host disease while still preventing transplant rejection. The study has completed both its Phase I and Phase Ib parts, focusing on safety and immune recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bendamustine and cyclophosphamide
- What this could lead to
- If successful, this could lead to a safer way to prevent graft-versus-host disease after a half-matched bone marrow transplant, making this option more accessible for blood cancer patients.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results are preliminary. The substitution may not work as well as standard treatment, and risks like graft failure or infection remain.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Aug 2025
- Lead sponsor
-
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
-
4 to 30 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Be willing and able to provide written consent/assent for the trial. * Diagnosed with one of the following high-risk malignancies, which require hematopoietic cell transplantation (HCT) but do not have an available Human Leukocyte Antigen (HLA)-matched related or unrelated donor or acceptable cord blood * High risk acute lymphoblastic leukemia (ALL) in 1st complete remission (CR1) or greater * High risk acute myelogenous leukemia (AML) in CR1 or greater * High risk undifferentiated acute leukemia * High risk myelodysplastic syndrome (MDS) * Chronic Myelogenous Leukemia (CML) failing or intolerant to Tyrosine Kinase Inhibitors (TKIs) or in accelerated, blastic phase, or in second or subsequent chronic phase * Lymphoma, (Hodgkin and Non-Hodgkins Lymphoma including marginal zone, follicular lymphoma, chemotherapy-sensitive large-cell, mantle cell lymphoma, gray zone, and Burkitt's lymphoma in remission). * At least one haploidentical related donor is available for bone marrow harvest. * Molecular based HLA typing for the HLA-A, -B, -Cw, beta chain (-DRB1) and - DQ Beta 1 Locus (DQB1loci) to the resolution is needed to establish haploidentity. * A minimum match of 5/10 is required. * No availability of an 8/8 HLA-matched related or unrelated donor or clinical urgency for transplant (e.g., needed within 4-8 weeks) at which time an acceptable unrelated donor will not be available. Exclusion Criteria: * Refractory acute leukemia (\>5% blasts) or progressive disease * Untreated or progressive central nervous system leukemia * Refractory to chemotherapy lymphoma * Co-morbidities precluding patient's ability to tolerate BMT * Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) \> 5 x upper limit of normal (ULN) * Bilirubin \> 2 x ULN * Creatinine greater than \>2 x ULN for age or creatinine clearance/glomerular filtration rate (GFR) \<40 ml/min/1.73m2 * Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% of normal or O2 Sat \<92% * Cardiac: left ventricular ejection fraction \<35% * Active infection at time of hospital admission of Haplo BMT * Documented fungal infection or highly suspected and receiving treatment for presumed fungal infection within 3 months of BMT * HIV positive * Karnofsky score (adults) \< 60% or Lansky score \< 50% (pediatrics). * Positive pregnancy test for girls post menarche or women of childbearing age. * Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and/or informed consent impossible. * Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.
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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.
Contacts and locations
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Engineered immune cells aim to wipe out stubborn leukemia
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Triple drug combo targets mantle cell lymphoma
- The immune cells that could make stem cell transplants work better