New stem cell transplant trial offers hope for blood cancer patients
NCT ID NCT04195633
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stem cell transplant from half-matched (haploidentical) donors for people with various blood cancers. Before the transplant, patients receive chemotherapy and low-dose radiation to prepare their body. The goal is to replace diseased bone marrow with healthy donor cells that can fight the cancer. This is a Phase 2 trial with 60 participants, focusing on controlling the disease rather than providing a cure.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2021
- Expected to finish
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Mar 2029
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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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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 Criteria: * 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.
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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
1 site. 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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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Double-Drug attack on Hard-to-Treat lymphomas
- Can an HDAC inhibitor wipe out residual leukemia cells?
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?