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Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

StatusRecruiting
PhasePhase 2
Started2021-01-25
View on ClinicalTrials.gov ↗

Amendment history

2026-05-27
minor
Study Status, Contacts/Locations v32
Study sitescontacts updated at 1 of 1 site
2026-02-24
minor
Study Status v31
Primary completion date2026-02-19→2027-04-15
Completion date2028-01-10→2029-03-12
2025-11-07
minor
Study Status, Arms and Interventions, Outcome Measures v30
InterventionsAllogeneic Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure)…→Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure)…
Secondary endpoints8 entries, revised
Cumulative incidence of relapseRelapse
2025-07-17
minor
Study Status v29
Re-verified, no change to tracked fields
2025-01-10
minor
Study Status v28
Primary completion date2024-12-31→2026-02-19
Completion date2026-12-31→2028-01-10
Show 27 earlier versions
2024-08-26
minor
Study Status, Study Description, Arms and Interventions v27
InterventionsAllogeneic Hematopoietic Stem Cell Transplantation (Procedure), Cyclophosphamide (Drug), Cyclosporine (Drug), Filgrastim (Biological)…→Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure)…
Study description+361 characters
[...] lute neutrophil count is > 1,000/uL for 3 consecutive days. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and computed tomography (CT) or positron emission tomography (PET)/CT on study. ARM B (LOW DOSE TREOSULFAN): Patients receive low dose treos [...] sodium or mycophenolate mofetil, and filgrastim as in Arm A. Additionally, patients undergo bone marrow aspiration and biopsy, and echocardiography at baseline and blood sample collection and CT or PET/CT on study. After completion of transplant, patients are followed up a [...]
2024-05-21
minor
Study Status v26
Re-verified, no change to tracked fields
2023-11-21
minor
Study Status v25
Primary completion date2023-12-31→2024-12-31
Completion date2025-12-31→2026-12-31
2023-05-12
minor
2 amendments v23-v24
2 re-verifications since 2023-04-21, no change to tracked fields
2022-10-26
minor
Study Status, Eligibility v22
Eligibility criteria+22 characters
[...] 5% of detectable blasts in bone marrow specimen, evaluated noper earlierstandard thanof one month before conditioning regimen startcare. Patients with documented CR but without hematologic recove [...] erformed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA). DONOR: Donor must meet selection criteria as defined by the [...] be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) < 5000 after desensitization treatment, will be reviewedconsidered byeligible to participate in the principalstudy. The investigatorfirst and10 con [...] [...]
2022-09-19
minor
2 amendments v20-v21
2 re-verifications since 2022-03-16, no change to tracked fields
2022-02-23
notable
Suspended→Recruiting Study Status, Contacts/Locations v19
Trial statusSuspended→Recruiting
Reason stoppedUnacceptable Toxicity→not stated
Study sitesdetails revised at 1 of 1 site
2021-12-16
notable
Recruiting→Suspended Study Status, Contacts/Locations v18
Trial statusRecruiting→Suspended
Reason stoppednot stated→Unacceptable Toxicity
Study sitesdetails revised at 1 of 1 site
2021-09-29
minor
Study Status, Eligibility v17
Eligibility criteria+1 characters
[...] capacity of the lung for carbon monoxide (DLCO) corrected >= 70% mm Hg DLCO corrected between 60% - 69% mm Hg and partia [...]
2021-09-02
minor
Study Status, Outcome Measures, Eligibility v16
Eligibility criteria+90 characters
[...] Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification Subjects must be >= 6 months old Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) [...] rate, patients will be screened for anti-DSA pre-transplant,. Patients andwith in case of positivity, the donorDSA will be excludedreviewed by the principal investigator and considered for desensitization treatment.
Secondary endpoints6 to 8 entries
Overall survival Cumulative incidence of relapse
2021-07-23
minor
2 amendments v14-v15
2 re-verifications since 2021-05-18, no change to tracked fields
2021-03-18
minor
Study Identification, Study Status, Sponsor/Collaborators, Arms and Interventions, Eligibility v13
Eligibility criteria-91 characters
[...] compatibility Major ABO incompatibility Exclusion Criteria: Patients with evidence of liver synthetic dysfunction or severe cirrhosis will be excluded Active, uncontrolled, life-threatening viral, bacterial or f [...]
Collaborators1 entry, revised
Nationalmedac Cancer Institute (NCI)GmbH
2021-02-03
minor
Study Status v12
Start dateestimated 2021-02-11→confirmed 2021-01-25
2021-01-11
minor
Study Status v11
Start date2021-01-09→2021-02-11
2020-12-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start date2020-12-16→2021-01-09
Study sitesdetails revised at 1 of 1 site
2020-11-16
minor
Study Status v9
Start date2020-11-14→2020-12-16
2020-10-14
minor
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v8
Start date2020-10-03→2020-11-14
Eligibility criteriarevised
[...] ogeneic hematopoietic cell transplant are eligible, but the firstprior transplant must have been performed at least 63 months prior to enrollment, unless in case of graft failure [...]
Study description+7 characters
[...] on day 5, patients receive cyclosporine IV twice daily (BID) or three times daily (TID) over 1-2 hours or orally (PO) (after 3 months, in the abse [...] ing on day 5, patients also receive mycophenolate sodium PO three times daily (TID) or mycophenolate mofetil IV or PO TID until day 35 (may be [...]
2020-09-23
minor
Study Status v7
Re-verified, no change to tracked fields
2020-09-08
minor
Study Status v6
Primary completion date2022-12-27→2023-12-31
Completion date2022-12-27→2025-12-31
2020-09-03
minor
Study Identification, Study Status v5
Start date2020-09-03→2020-10-03
2020-08-03
minor
Study Status v4
Start date2020-08-01→2020-09-03
2020-07-01
minor
Study Status v3
Start date2020-07-01→2020-08-01
2020-03-03
minor
Study Status v2
Start date2020-03-03→2020-07-01
2020-02-03
minor
Study Status v1
Start date2020-01-31→2020-03-03
2019-12-10
minor
Original filing
This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Trial Details
NCT Number NCT04195633
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: medac GmbH
Conditions Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Adult Diffuse Large Cell Lymphoma, Anaplastic Large Cell Lymphoma, Burkitt Lymphoma, Chronic Myeloid Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia +11 more
Enrollment 60 participants
Start Date 2021-01-25
Primary Completion 2027-04-15 (estimated)
Study Completion 2029-03-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-29