CD34+ Transplants for Leukemia and Lymphoma

Trial Title: CD34+ Transplants for Leukemia and Lymphoma

NCT ID: NCT05565105

Condition: Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Acute

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Cyclophosphamide
Melphalan
Busulfan
Thiotepa
Fludarabine

Conditions: Keywords:
Stem Cell Transplant

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Total Body Irradiation (TBI)
Description: Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of < 15 cGy/minute.
Arm group label: Regimen A: TBI/Thiotepa/Cyclophosphamide

Intervention type: Drug
Intervention name: Thiotepa
Description: Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
Arm group label: Regimen A: TBI/Thiotepa/Cyclophosphamide

Other name: Thioplex

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m^2 x 5 if cyclophosphamide is contraindicated
Arm group label: Regimen A: TBI/Thiotepa/Cyclophosphamide

Other name: Cytoxan

Intervention type: Drug
Intervention name: Busulfan
Description: Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
Arm group label: Regimen B: Busulfan/Melphalan/Fludarabine

Other name: Busulfex

Intervention type: Drug
Intervention name: Melphalan
Description: Melphalan: 70 mg/m^2/day x 2
Arm group label: Regimen B: Busulfan/Melphalan/Fludarabine

Other name: Alkeran

Intervention type: Drug
Intervention name: Fludarabine
Description: Fludarabine: 25 mg/m^2/day x 5
Arm group label: Regimen B: Busulfan/Melphalan/Fludarabine

Other name: Fludara

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 74 Years

Healthy volunteers: No

Locations:

Facility:
Name: Baptist Health South Florida/Miami Cancer Institute

Address:
City: Miami
Zip: 33176
Country: United States

Contact:
Last name: Guenther Koehne, MD, Ph.D.

Phone: 786-596-2000
Email: GuentherK@baptisthealth.net

Start date: October 2024

Completion date: October 2031

Lead sponsor:
Agency: Guenther Koehne
Agency class: Other

Source: Baptist Health South Florida

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05565105