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Compares treatment options for Acute Biphenotypic Leukemia
Official title Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
ClinicalTrials.gov ID: NCT03779854
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 biphenotypic leukemia.
Also referred to as 1,1',1"-phosphinothioylidynetrisaziridine, Oncotiotepa.
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 studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease).
- 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 6 to 26. Healthy volunteers may be eligible.
You may be able to join if
- The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal...
- Acute lymphoblastic leukemia (ALL) with \< 5% marrow blasts.
- Acute myeloid leukemia (AML) with \< 25% marrow blasts.
- Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia [ABL], ambiguous lineage [ALAL], mixed...
- Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule...
You likely can't join if
- Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the...
- Patients on other experimental protocols for the prevention of GVHD.
- Patient body weight:
- Matched related donor (MRD): \> 100 kg are ineligible
- Matched unrelated donor (MUD): \> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.
- HIV-positive.
See the full eligibility criteria
- The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):
- Acute lymphoblastic leukemia (ALL) with \< 5% marrow blasts.
- Acute myeloid leukemia (AML) with \< 25% marrow blasts.
- Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia [ABL], ambiguous lineage [ALAL], mixed phenotype acute leukemia [MPAL], blastic plasmacytoid dendritic cell...
- Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)
- Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form
- Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8/8 match for human leukocyte antigen [HLA]-A, -B, -C, -DRB1).
- Planned product type for infusion is PBSC or BM (i.e. not cord blood):
- For feasibility phase, planned product type for infusion must be PBSC.
- For RCT, planned product type must be PBSC or BM.
- Karnofsky or Lansky score \>= 60%.
- Left ventricular ejection fraction (LVEF) at rest \>= 40%.
- Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \>= 60% predicted by pulmonary function tests (PFTs) \ Patients who are unable to perform PFTs (age \ = 92% on room air.
- Total bilirubin =\ 2 x ULN are disease- or medication-related). \ If value(s) are \> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician...
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\ 2 x ULN are disease- or medication-related). \ If value(s) are \> 2 x ULN and not disease- or medication related, patient must be evaluated by a...
- Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \> 40 mL/min/1.73m\^2 must be obtained (measured by 24-hour [hr] urine specimen or nuclear...
- Age (Years): Maximum SCr (mg/dL)
- =\< 5: 0.8
- 6-10: 1
- 11-15: 1.2
- \> 15: 1.5
- Recipient informed consent/assent/legal guardian permission documentation must be obtained.
- DONOR: May be related (MRD) or unrelated (MUD) to the subject.
- DONOR: Must be matched to the subject at 8/8 HLA alleles (HLA-A, -B, -C, and -DRB1)
- DONOR: Be \>=14 years of age.
- DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).
- DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).
- DONOR: MUDs:
- Must give informed consent according to 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))
- Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
- DONOR: MRDs:
- Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and/or nucleic acid testing [NAT] and/or other approved testing)
- Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).
- Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.
- Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first...
- Patients on other experimental protocols for the prevention of GVHD.
- Patient body weight:
- Matched related donor (MRD): \> 100 kg are ineligible
- Matched unrelated donor (MUD): \> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.
- HIV-positive.
- Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection...
- Life expectancy \< 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).
- Significant medical condition that would make recipient unsuitable for HCT.
- Prior allogeneic or autologous HCT.
- Females who are pregnant or breastfeeding.
- Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.
- Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Cleveland, Ohio, United States
- Portland, Oregon, 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, 6 months to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Cleveland, Ohio, United States and 3 more location(s). 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.