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New treatment option for Acute Lymphoblastic Leukemia
Official title Two Step Haplo With Radiation Conditioning
ClinicalTrials.gov ID: NCT05031897
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as 2-Fluoro-9-beta-arabinofuranosyladenine, 2-Fluorovidarabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Radiation-based cohort diagnoses:
- Acute myeloid leukemia
- Acute lymphoid leukemia in remission
- Myelodysplasia (MDS)
- Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
See the full eligibility criteria
- Radiation-based cohort diagnoses:
- Acute myeloid leukemia
- Acute lymphoid leukemia in remission
- Myelodysplasia (MDS)
- Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement
- Multiple myeloma
- Chronic myeloid leukemia
- Myelofibrosis
- Myeloid malignancy not otherwise specified
- Chronic myelomonocytic leukemia
- Essential thrombocytopenia or polycythemia vera
- T cell leukemia
- T cell lymphoma without significant lymph node disease burden
- Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable
- Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment...
- Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
- Chemotherapy-based cohort diagnoses:
- Hodgkin or non-Hodgkin lymphoma
- Small lymphocytic lymphoma/CLL
- Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease
- Hematological malignancy in patients who cannot receive \> 2 Gy radiation
- Aplastic anemia and other non-malignant hematologic dyscrasias
- Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
- Human leukocyte antigen (HLA) identical cohort diagnoses: \ Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls...
- Left ventricular ejection fraction of \>= 50%
- Diffusion lung capacity of oxygen \>= 50% and forced expiratory volume at 1 second \>= 50% of predicted corrected for hemoglobin
- Serum bilirubin =\< 1.8
- Aspartate aminotransferase or alanine aminotransferase =\< 2.5 x upper limit of normal
- Creatinine clearance of \>= 60 mL/min
- Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:
- Patients \ = 60% and an HCT-CI score of 5 or less
- Patients aged 60 to 65 years must have a KPS of \>= 60% and an HCT-CI score of 4 or less
- Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less
- Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less
- (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the...
- Patients must be willing to use contraception if they have childbearing potential
- Patient or patient's guardian is able to give informed consent
- Patients should have a life expectancy of \>= 6 months for reasons other than their underlying hematologic/oncologic disorder
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
- Patients should not be:
- Human immunodeficiency virus positive
- Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and/or a negative cerebral spinal fluid analysis
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Philadephia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadephia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.