Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute
Conditions
Keywords
Stem Cell Transplant
Brief summary
This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.
Interventions
RADIATIONTotal Body Irradiation (TBI)
Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
DRUGThiotepa
Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
DRUGCyclophosphamide
Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
DRUGBusulfan
Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
DRUGMelphalan
Melphalan: 70 mg/m\^2/day x 2
DRUGFludarabine
Fludarabine: 25 mg/m\^2/day x 5
Sponsors
Guenther Koehne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Malignant conditions or other life-threatening disorders correctable by transplant for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as: 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. The following inclusion criteria are also required: * 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
* Female patients who are pregnant or breast-feeding * Active viral, bacterial or fungal infection * Patient seropositive for HIV-I /II; HTLV -I /II * Presence of leukemia in the CNS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of graft versus host disease (GvHD) | Two years | Incidence of acute and chronic GvHD |
| Severity of disease | Two years | Severity of the adverse events will be reported based on the CTCAE Version 5. |
| Incidence of transplant-related mortality (TRM) | Two years | TRM includes fatal complications resulting from the allogeneic transplant and/ or treatment regimens such as graft failure, GvHD, hemorrhages, and infections. |
| Change in overall survival (OS) | Six months, one year, two years | OS is defined as time from transplant to death or last follow-up. |
| Change in disease free survival (DFS) | Six months, one year, two years | DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow- up, from the time of transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients optimal and suboptimal doses | Two years | The proportion of patients receiving optimal cell doses (CD34+: \>5x 10\^6/kg and CD3+: \< 5 x10\^4/kg) and suboptimal doses (CD34+: \<3 x 10\^6/kg and CD3+: \>5 x 10\^4/kg). |
Countries
United States
Contacts
CONTACTGuenther Koehne, MD, PhD
CONTACTClaudia Torralbas, RN
PRINCIPAL_INVESTIGATORGuenther Koehne, MD, PhD
Baptist Health South Florida/Miami Cancer Institute
Outcome results
None listed