Donor Stem Cell Transplant for Blood Cancers
This study is testing a donor stem cell transplant combined with specific medications (treosulfan, fludarabine, cyclophosphamide, cyclosporine, filgrastim) and total-body irradiation for people with certain blood cancers like acute leukemia and lymphoma. The goal is to see how well this treatment works. Before the transplant, chemotherapy and radiation help prepare your body by stopping the growth of cancer cells and preventing your immune system from rejecting the new stem cells. After the transplant, healthy stem cells from a donor can help your body make new blood cells and fight any remaining cancer. The study is looking to see if the transplant is successful and if the body accepts the new cells, measured up to two years after the transplant. This study is for patients aged 6 months and older with specific types of acute leukemia or lymphoma that are in remission.
- Study design
- This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive treosulfan, fludarabine, total-body irradiation, and a stem cell transplant. They will also receive cyclophosphamide, cyclosporine, and filgrastim, along with bone marrow aspirations, echocardiograms, blood tests, and CT or PET/CT scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for graft failure/rejection for up to 2 years post-transplant.
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NCT04195633
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
Recruiting
PHASE2Ages 6+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationCyclophosphamideCyclosporineFilgrastimFludarabineMycophenolate Mofetil
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft failure/rejection
Measured over Up to 2 years post-transplant
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Phuong Vo, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Acute leukemia (AL) that includes acute myeloid leukemia (AML) / acute lymphoblastic leukemia (ALL) / mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study
Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor
Chronic myelomonocytic leukemia (CMML)
Myelodysplastic syndromes (MDS)
Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response
CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Low grade lymphoma (chronic lymphocytic leukemia \[CLL\]/small lymphocytic lymphoma \[SLL\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR/PR
For CLL/SLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL
CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Large cell lymphoma in \> second CR (CR2)/ \>= PR2
CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR/PR
CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \< 1 cm) and splenomegaly (\< 13 cm), absence of constitutional symptoms, PLL cells \< 5% in bone marrow and circulating lymphocytes count \< 4 x 10\^9/L. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\< 30 x 10\^9/L (and a decrease of \>= 50% from baseline)
Hodgkin Lymphoma in \> CR2/PR2
CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Subjects must be \>= 6 months old
Karnofsky \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)
Lansky score \>= 50 (for children)
Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \>= 40% or shortening fraction \> 22%
Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:
Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \>= 70% mm Hg
DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \>= 70 mm Hg
DLCO corrected between 50% - 59% mm Hg and pO2 \>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \>= 92% on room air. May not be on supplemental oxygen
Total bilirubin \< 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
Alkaline phosphatase =\< 5 x ULN
Creatinine \< 2.0 mg/dl (adults) or estimated creatinine clearance \> 40 ml/min (pediatrics)
All adults with a creatinine \> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \> 40 ml/min
If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed
Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant
Written and signed informed consent
DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5/10 HLA loci
DONOR: Age \>= 12 years
DONOR: Weight \>= 40 Kg
DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.
DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:
For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor
Red blood cell compatibility
Red blood cell (RBC) cross match compatible
Minor ABO incompatibility
Major ABO incompatibility
Exclusion
Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation
Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years
Pregnant or breastfeeding
Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide
Dosing with another investigational agent within 30 days prior to entry in the study
Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning (day -6)
DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \< 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.
What this trial measures
- Graft failure/rejectionUp to 2 years post-transplant
The analysis for graft failure will be conducted among all patients as well as separately among patients by Arm A versus Arm B.