Clinical trial · Interventional
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
Conditioning for Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and tacrolimus and methotrexate after transplant may stop this from happening.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, PBSC transplant)
- description
- Patients receive fludarabine phosphate IV over 30 minutes on days -9 to -6, busulfan IV over 3 hours on days -5 to -2, and anti-thymocyte globulin IV over 6 hours on days -3 and -2 and over 4 hours on day -1. Patients undergo allogeneic PBSC transplant on day 0. Patients then receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and taper to day 180 and methotrexate IV on days 1, 3, 6, and 11.
- interventionNames
- Drug: fludarabine phosphate
- Drug: busulfan
- Biological: anti-thymocyte globulin
- Drug: tacrolimus
- Drug: methotrexate
- Procedure: peripheral blood stem cell transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Incidence of acute GvHD
- timeFrame
- Day 100 post-transplant
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic myelogenous leukemia in chronic phase, accelerated phase and treated blast phase (CP2) * Acute myeloid leukemia (AML) in remission or early relapse (\< 10% marrow blasts) * Myelodysplastic syndromes (MDS) ( all risk groups) * Other myeloproliferative disorders * DONOR: related or unrelated donors matched for human leukocyte antigen (HLA)-A, B, C, DRB1, and DQB1 defined by high resolution deoxyribonucleic acid (DNA) typing or mismatched for a single HLA-A, B, C, DRB1 or DQB1 allele * DONOR: donor must consent to peripheral blood stem cell (PBSC) mobilization with granulocyte colony-stimulating factor (G-CSF) and leukapheresis; related donors will be collected at Fred Hutchinson Cancer Research Center (FHCRC), while unrelated donors will be collected through the National Marrow Donor Program (NMDP) or other donor centers * DONOR: Age 12-75 yrs Exclusion Criteria: * Cardiac insufficiency requiring treatment or symptomatic coronary artery disease * Hepatic disease, with aspartate aminotransferase (AST) \> 2 times normal * Severe hypoxemia, oxygen partial pressure (pO2) \< 70 mm Hg, with decreased diffusion capacity of carbon monoxide (DLCO) \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted * Impaired renal function (creatinine \> 2 times normal or estimated creatinine clearance \< 60 ml/min) * MALE: (\[140 -age in years\] x ideal body weight \[kg\])/72 x serum creatinine (SCr) (mg/dL) * FEMALE: .85 x (\[140-age in years\] x ideal body weight \[kg\])/72 x SCr (mg/dL) * Human immunodeficiency virus (HIV)-positive patients due to risk of reactivation or acceleration of HIV replication * Female patients who are pregnant or breast feeding * Life expectancy severely limited by diseases other than malignancy * DONOR: donors who for any reason are unable to tolerate the mobilization and leukapheresis procedure * DONOR: donors who are HIV-positive, or hepatitis B or C antigen-positive * DONOR: female donors who have a positive pregnancy test
References
Publications (0)
Data not yet available