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Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

StatusRecruiting
PhasePhase 2
Started2019-11-19
View on ClinicalTrials.gov ↗

Amendment history

2026-03-10
Study Status v30
Primary completion date2026-12-31→2027-12-31
Completion date2028-12-31→2029-12-31
2025-09-11
3 amendments v27-v29
3 re-verifications since 2024-09-18, no change to tracked fields
2024-08-20
Study Status, Arms and Interventions, Eligibility v26
Eligibility criteria+58 characters
[...] stic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia or, chronic myeloid leukemia [CML] with blast crisis or other chronic myeloproliferative neoplasm) in first or subsequent morphological remission (<5% marrow [...] dysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receivin [...]
2024-05-28
Study Identification, Study Status, Eligibility v25
Eligibility criteriarevised
[...] LA-matched related donors will be excluded if they weigh >= 100110 kg. Patients with HLA-matched unrelated donors will be excluded if they weigh >= 100110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh >= 8090 kg. Patients who are positive for human immunodeficiency vi [...]
2024-01-09
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v24
InterventionsAllogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Busulfan (Drug), Cyclophosphamide (Drug), Cyclosporine (Drug)…→Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy…
Eligibility criteria+127 characters
[...] plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia or chronic myeloid leukemia ([CML)] with blast crisis) in first or subsequent morphological rem [...] xcluded from the protocol. Patients with Gilbert's syndrome andrequire GI physician consultation but may be included on the protocol. Patients with no other known liver function abnormality or with reversibl [...]
Study description+202 characters
[...] (IV) over 3 hours on days -6 and -5, fludarabine IV over 30 to 60 minutes on days -6 to -2, tacrolimus (or cyclosporine or si [...] A2 (BUSULFAN BASED): Patients receive fludarabine IV over 30 to 60 minutes on days -6 to -2, busulfan IV over 180 minutes on d [...] on day 0. Patients also receive cyclophosphamide IV over 1 hourto 2 hours on days 3 and 4, and tacrolimus (or cyclosporine or sirolim [...] for liquid). ARM C2: Patients receive fludarabine IV over 30 to 60 minutes on days -5 to -2, busulfan IV over 180 minutes on days -5 to -2, PBSC IV on day 0, cyclophosphamide IV over 1 hourto 2 hours on days 3 and [...] [...]
Show 23 earlier versions
2023-11-15
Study Status v23
Primary completion date2025-08-01→2026-12-31
Completion date2026-08-01→2028-12-31
2023-09-20
Study Status, Study Description v22
Study description+152 characters
[...] limus if toxicities occur) IV continuously starting on day 5 approximately 24 hours after the end of the second dose of cyclophosphamide. If there is no evidence of grade II-IV acute GVHD on or pr [...] limus if toxicities occur) IV continuously starting on day 5 approximately 24 hours after the end of the second dose of cyclophosphamide. If there is no evidence of grade II-IV acute GVHD on or pr [...]
2023-07-10
Study Status, Conditions, Eligibility, Contacts/Locations v21
Eligibility criteria-176 characters
[...] (inclusive) are eligible for TBI-based conditioning regimens. Patients aged 1-60 years old (inclusive) are eligible for b [...] ulfan-based conditioning regimens (with or without TBI 4 Gy). Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 ma [...] of urgent medical need (exception 21 CFR 1271.65(b)(iii)). Must be vaccinated against COVID19. 'COVID vaccinated' is as defined by the NMDP and number of required doses may vary according to vaccine manufacturer and evolving guidelines. Exclusion Criteria: Patients with central nervous system (CN [...]
Study sitesdetails revised at 1 of 3 sites
2023-05-18
Study Status, Eligibility v20
Eligibility criteria+50 characters
[...] acute leukemia, blastic plasmacytoid dendritic cell neoplasm or, lymphoblastic lymphoma or chronic myeloid leukemia (CML) with blast crisis) in first or subsequent morphological remission (< 5% marro [...]
2023-04-24
Study Status v19
Primary completion date2023-08-01→2025-08-01
Completion date2024-08-01→2026-08-01
2022-10-26
Study Status, Study Description, Arms and Interventions v18
Study arms4→6
Study description+982 characters
[...] is tapered per month for capsules (or per week for liquid). ARM D: (DISCONTINUED NOVEMBER 2021): Patients are assigned to 1 of 2 arms. ARM D1: Patients undergo TBI BID on days -6 to -4, and receive cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day [...] After completion of study treatment, patients are followed u [...]
2022-10-18
2 amendments v16-v17
2 re-verifications since 2022-10-03, no change to tracked fields
2022-04-25
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v15
Study arms6→4
Eligibility criteria+480 characters
[...] morphological remission (< 5% marrow blasts by morphology). Myelodysplastic syndrome (MDS) with a history of excess blasts (≥5% in marrow blasts by morphology) and a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or cytotoxic chemotherapy) within the past 3 months. Patient age 1-60 years old (inclusive) at the time of inform [...] of urgent medical need (exception 21 CFR 1271.65(b)(iii)). Must be vaccinated against COVID19. 'COVID vaccinated' is as defined by the NMDP and number of required doses may vary according to vaccine manufacturer and evolving guide [...] [...]
Study description-973 characters
OUTLINE: Patients are assigned to Arm D or randomized to 1 of 2 arms (Arms A and C). ARM A: Patients a [...] is tapered per month for capsules (or per week for liquid). ARM D: Patients are assigned to 1 of 2 arms. ARM D1: Patients undergo TBI BID on days -6 to -4, and receive cyclophosphamide IV over 1 hour on days -3 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC IV on day 0, and methotrexate IV on day [...] After completion of study treatment, patients are followed u [...]
Study title+34 characters
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
2021-10-07
Study Status, Study Description, Arms and Interventions, Eligibility v14
Study arms3→6
InterventionsAllogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Cyclophosphamide (Drug), Cyclosporine (Drug), Fludarabine (Drug)…→Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Busulfan (Drug), Cyclophosphamide (Drug), Cyclosporine (Drug)…
Eligibility criteria+116 characters
[...] remission (< 5% marrow blasts by morphology). Patient age 1-5060 years old (inclusive) at the time of informed consent Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens Patients aged 1-60 years old (inclusive) are eligible for busulfan-based conditioning regimens (with or without TBI 4 Gy) Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 mat [...] the PI. Patients with a known hypersensitivity to tacrolimus, MTX or thymoglobulinMTX Patients who have received checkpoint inhibitors within thr [...] ical Laboratory Improvement Act (CLIA)-certified laboratory. DON [...]
Study description+1,681 characters
OUTLINE: Patients are assigned to Arm D or randomized to 1 of 32 arms (Arms A and C). ARM A: Patients are assigned to 1 of 2 arms. ARM AA1 (TBI BASED): Patients undergo total-body irradiation (TBI) twice daily [...] apered per month for capsules (or per week for liquid). ARM CA2 (BUSULFAN BASED): Patients receive fludarabine IV over 30 minutes on days -6 to -2, busulfan IV over 180 minutes on days -5 to -2, and undergo TBI BID on days -4 to -2 or -3 today -1, and receive PBSC IV on day 0. Patients also receive cyclophosphamide IV over 1 hour on days 3 and 4, and tacrolimus (or cyclosporine or siroli [...] [...]
2021-04-27
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v13
Enrollment target160→120
Study arms4→3
InterventionsAllogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Allogeneic CD34-positive Enriched Peripheral Blood Stem Cells…→Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Cyclophosphamide (Drug), Cyclosporine (Drug), Fludarabine (Drug)…
Eligibility criteria+98 characters
[...] morphological remission (< 5% marrow blasts by morphology). Patient age 1 -50 years old (inclusive) at the time of informed consent Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 mat [...] he donor is a first or second degree relative (exception 21 CRFCode of Federal Regulations [CFR] 1271.65(b)(i)). DONOR: Matched unrelated donors: Must conse [...] ligible with statement of urgent medical need (exception 21 CRFCFR 1271.65(b)(iii)). Exclusion Criteria: Patients with central [...] the PI. Patients with a known hypersensitivity to tacrolimus or, MTX or thymoglobulin. Patients who have received checkpoint i [...] [...]
Secondary endpoints5 entries, revised
Graft rejection or irreversible graft failure (> 14 days duration)
Study description-255 characters
OUTLINE: Patients are randomized to 1 of 43 arms. ARM A: Patients undergo total-body irradiation (TBI) [...] is tapered per month for capsules (or per week for liquid). ARM B: Patients undergo TBI BID on days -9 to -6, and receive thiotepa IV over 3 hours on days -5 and -4, anti-thymocyte globulin IV over 6-8 hours on days -4 and -3, cyclophosphamide IV over 1 hour on days -3 and -2, and CD34+ enriched PBSC IV on day 0. ARM C: Patients undergo TBI BID on days -4 to -2 or -3 to -1 [...]
2020-12-07
Study Status, Conditions, Arms and Interventions, Eligibility v12
Eligibility criteria+127 characters
[...] own hypersensitivity to tacrolimus or MTX or thymoglobulin. Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI. DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seroposit [...]
2020-11-12
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 3 sites
2020-09-03
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v10
Eligibility criteria+17 characters
[...] Patients with a known hypersensitivity to tacrolimus or MTX or thymoglobulin. DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropos [...]
Study descriptionrevised
[...] ays -10 to -7, and receive thiotepa intravenously (IV) over 43 hours on days -6 and -5, fludarabine IV over 30 minutes on [...] ergo TBI BID on days -9 to -6, and receive thiotepa IV over 43 hours on days -5 and -4, anti-thymocyte globulin IV over 6- [...]
2020-06-18
Study Status, Study Description, Arms and Interventions, Outcome Measures v9
InterventionsAllogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Allogeneic CD34-positive Enriched Peripheral Blood Stem Cells…→Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Allogeneic CD34-positive Enriched Peripheral Blood Stem Cells…
Secondary endpointsdetails revised at 1 of 5 entries
Study description+220 characters
OUTLINE: Patients are randomized to 1 of 4 arms. ARM A: Patients unde [...] fludarabine IV over 30 minutes on days -6 to -2, tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day -1, PBSC infusion starting on day -1, CD34+ enriched CD45RA-depleted donor T- [...] of grade II-IV acute GVHD on or prior to day 50, tacrolimus (or cyclosporine or sirolimus) is tapered per month for capsules (or per week for liquid). [...] ophosphamide IV over 1 hour on days 3 and 4, and tacrolimus (or cyclosporine or sirolimus if toxicities occur) IV continuously starting on day 5. If there is no [...] [...]
2020-03-27
Study Identification, Study Status v8
Re-verified, no change to tracked fields
2019-12-18
Study Status, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v7
Study sites2→3
InterventionsAllogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Allogeneic CD34-positive Enriched Peripheral Blood Stem Cells…→Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (Biological), Allogeneic CD34-positive Enriched Peripheral Blood Stem Cells…
Eligibility criteria+3 characters
[...] matched) related or unrelated donor capable of donating PBSC. Recipient informed consent/assent and/or legal guardian per [...] formed consent using the related donor informed consent form. Must meet institutional donor eligibility criteria or be in [...] al Marrow Donor Program (NMDP) donor regulatory requirements. Must meet eligibility criteria as defined by the NMDP or be [...]
2019-12-02
Study Status v6
Re-verified, no change to tracked fields
2019-11-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2019-11-15→2019-11-19
Study sitesdetails revised at 2 of 2 sites
2019-10-15
Study Status v4
Start date2019-10-15→2019-11-15
2019-09-23
Study Status v3
Start date2019-09-19→2019-10-15
2019-08-19
Study Status v2
Start date2019-08-08→2019-09-19
2019-07-08
Study Status v1
Start date2019-07-06→2019-08-08
2019-05-29
Original filing
This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood 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 NCT03970096
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
Enrollment 120 participants
Start Date 2019-11-19
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12