Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2026-01-31
2032-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regimen A: TBI/Thiotepa/Cyclophosphamide
Patients in enrolled in Regimen A will receive the following:
* Total Body Irradiation (TBI), hyper-fractionated to a dose of 1320 cGy depending on age, stage of disease and requirement of general anesthesia with lung shielding
* Thiotepa, 5 mg/kg/day x 2 days via IV infusion over 4 hours daily or 10 mg/kg on one day
* Cyclophosphamide, 60 mg/kg/day x 2 days via IV infusion over 2 hours daily (or if cyclophosphamide is contraindicated, fludarabine at 25 mg/m\^2 x 5 days may be substituted)
Total Body Irradiation (TBI)
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
Thiotepa
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
Cyclophosphamide
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
Regimen B: Busulfan/Melphalan/Fludarabine
Patients in enrolled in Regimen B will receive the following:
* Busulfan, IV 0.8 mg/kg q6hours x 10 or 12 doses over 3 days, depending on the disease
* Melphalan, 70 mg/m\^2/day x 2 days via IV infusion over 30 minutes daily
* Fludarabine, 25 mg/m\^2/day x 5 days via IV infusion over 30 minutes daily
Busulfan
Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
Melphalan
Melphalan: 70 mg/m\^2/day x 2
Fludarabine
Fludarabine: 25 mg/m\^2/day x 5
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total Body Irradiation (TBI)
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
Thiotepa
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
Cyclophosphamide
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
Busulfan
Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
Melphalan
Melphalan: 70 mg/m\^2/day x 2
Fludarabine
Fludarabine: 25 mg/m\^2/day x 5
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. AML in 1st remission - for patients who is AML does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16).
2. Secondary AML in 1st remission
3. AML in 1st relapse or 2nd remission
4. ALL/CLL in patient remission clinical or molecular features indicating a high risk for relapse; or ALL/CLL 2nd remission
5. CML failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
6. Non-Hodgkin's lymphoma with chemo responsive disease in any of the following categories:
1. Intermediate or high-grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
2. Any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.
7. Chronic myelomonocyte leukemia: CMML-1 and CMML-2.
* Patient's age includes from ≥18 to ≤74 years old.
* Patients may be of either gender or any ethnic background.
* Patients must have a Karnofsky (adult) Performance Status of at least 70%
* Patients must have adequate organ function measured by:
Cardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.
Hepatic: \< 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. AML Chloroma obstructing the biliary tree). Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.
Renal: serum creatinine: s; 1.2 mg/dL or if serum creatinine is outside the normal range, then CrCl \> 30 ml/min (measured or calculated/estimated).
Pulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).
Each patient must be willing to participate as a research subject and must sign an informed consent form.
Exclusion Criteria
* Active viral, bacterial or fungal infection
* Patient seropositive for HIV-I /II; HTLV -I /II
* Presence of leukemia in the CNS
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guenther Koehne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guenther Koehne
Deputy Director and Chief of Blood and Marrow Transplant, Hematologic Oncology and Benign Hematology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guenther Koehne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Baptist Health South Florida/Miami Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baptist Health South Florida/Miami Cancer Institute
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Guenther Koehne, MD, Ph.D.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7.
Handgretinger R, Klingebiel T, Lang P, Schumm M, Neu S, Geiselhart A, Bader P, Schlegel PG, Greil J, Stachel D, Herzog RJ, Niethammer D. Megadose transplantation of purified peripheral blood CD34(+) progenitor cells from HLA-mismatched parental donors in children. Bone Marrow Transplant. 2001 Apr;27(8):777-83. doi: 10.1038/sj.bmt.1702996.
Urbano-Ispizua A, Rozman C, Pimentel P, Solano C, de la Rubia J, Brunet S, Perez-Oteyza J, Ferra C, Zuazu J, Caballero D, Bargay J, Carvalhais A, Diez JL, Espigado I, Alegre A, Rovira M, Campilho F, Odriozola J, Sanz MA, Sierra J, Garcia-Conde J, Montserrat E; Spanish Group for Allogeneic Peripheral Blood Transplantation (Grupo Espanol de Trasplante Hemopoyetico) and Instituto Portugues de Oncologia-Porto. Risk factors for acute graft-versus-host disease in patients undergoing transplantation with CD34+ selected blood cells from HLA-identical siblings. Blood. 2002 Jul 15;100(2):724-7. doi: 10.1182/blood-2001-11-0057.
Jakubowski AA, Small TN, Young JW, Kernan NA, Castro-Malaspina H, Hsu KC, Perales MA, Collins N, Cisek C, Chiu M, van den Brink MR, O'Reilly RJ, Papadopoulos EB. T cell depleted stem-cell transplantation for adults with hematologic malignancies: sustained engraftment of HLA-matched related donor grafts without the use of antithymocyte globulin. Blood. 2007 Dec 15;110(13):4552-9. doi: 10.1182/blood-2007-06-093880. Epub 2007 Aug 23.
Related Links
Access external resources that provide additional context or updates about the study.
Miami Cancer Institute
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-KOE-001
Identifier Type: -
Identifier Source: org_study_id