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Compares treatment options for Acute Leukemia
Official title Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
ClinicalTrials.gov ID: NCT03970096
What this study is testing
What is Thiotepa?
Thiotepa is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute leukemia.
Also referred to as Oncotiotepa, STEPA.
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 trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 60
You may be able to join if
- Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one...
- Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
- Acute myeloid leukemia (AML) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
- Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous...
- Myelodysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receiving...
You likely can't join if
- Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation. A patient may...
- Patients on other experimental protocols for prevention of GVHD.
- Patient weight:
- Patients with HLA-matched related donors will be excluded if they weigh \>= 110 kg.
- Patients with HLA-matched unrelated donors will be excluded if they weigh \>= 110 kg and must be discussed with the Fred Hutch protocol principal...
- Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.
See the full eligibility criteria
Who can join
- Patients who are considered appropriate candidates for myeloablative, TBI-containing allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
- Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
- Acute myeloid leukemia (AML) in first or subsequent morphological remission (\< 5% marrow blasts by morphology).
- Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm...
- Myelodysplastic syndrome (MDS) with a history of excess blasts (≥ approximately 5% in marrow blasts by morphology) and a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or...
- Patient age 1-60 years old (inclusive) at the time of informed consent
- Patients aged 1-50 years old (inclusive) are eligible for TBI-based conditioning regimens.
- Patients aged 1-60 years old (inclusive) are eligible for busulfan-based conditioning regimens (with or without TBI 4 Gy).
- Patient with an HLA-matched (HLA-A, B, C, DRB1, and DQB1 matched) related or unrelated donor capable of donating PBSC.
- Recipient informed consent/assent and/or legal guardian permission must be obtained.
- DONOR: HLA-matched related and unrelated donors (HLA-A, B, C, DRB1 and DQB1 matched based on high-resolution typing).
- DONOR: \>= 18 years old.
- DONOR: Willing to donate PBSC.
- DONOR: Matched related donors:
- Must give informed consent using the related donor informed consent form.
- Must meet institutional donor eligibility criteria or be ineligible with statement that the donor is a first or second degree relative (exception 21 Code of Federal Regulations [CFR] 1271.65(b)(i)).
- DONOR: Matched unrelated donors:
- Must consent according to the applicable National Marrow Donor Program (NMDP) donor regulatory requirements.
- Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii)).
What rules you out
- Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiation. A patient may have a history of CNS disease. However, any CNS disease must be...
- Patients on other experimental protocols for prevention of GVHD.
- Patient weight:
- Patients with HLA-matched related donors will be excluded if they weigh \>= 110 kg.
- Patients with HLA-matched unrelated donors will be excluded if they weigh \>= 110 kg and must be discussed with the Fred Hutch protocol principal investigator (PI) if they weigh \>= 90 kg.
- Patients who are positive for human immunodeficiency virus (HIV)-1, HIV-2, human T-cell lymphotropic virus (HTLV)1 or HTLV2.
- Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician; i.e. patients with active infections require infectious disease consultation...
- Patients with organ dysfunction, including:
- Renal insufficiency (creatinine \> 1.5 mg/dl) at the time of evaluation for the protocol. Patients with a known history of creatinine \> 1.5 mg/dl or a current serum creatinine above the normal range for age must have a...
- Left ventricular ejection fraction \< 45%.
- Carbon monoxide diffusing capability (DLCO) corrected \< 60%. Patients who are unable to perform pulmonary function tests (for example, due to young age and/or developmental status) will be excluded if the oxygen (O2)...
- Liver function abnormality. Patients who have liver function test (LFT)s (specifically, total bilirubin, aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) \>= twice the upper limit of normal should be...
- Patients who have received previous myeloablative allogeneic or autologous transplantation.
- Patients with a life expectancy \< 12 months from co-existing disease other than the leukemia or MDS.
- Patients who are pregnant or breast-feeding.
- Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT.
- Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.
- Patients with a known hypersensitivity to tacrolimus or MTX
- Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI
- DONOR: Donors who are HIV-1, HIV-2, HTLV-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection. Test must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved...
- Unrelated donors donating outside of the USA.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, 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, 1 year to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Pittsburgh, Pennsylvania, United States; Seattle, Washington, 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.