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New treatment option for Acute Leukemia
Official title Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
ClinicalTrials.gov ID: NCT04195633
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide 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 (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate.
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 a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older. Healthy volunteers may be eligible.
You may be able to join if
- Acute leukemia (AL) that includes acute myeloid leukemia (AML) / acute lymphoblastic leukemia (ALL) / mixed phenotype leukemia (MPAL) in complete...
- Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant...
- Chronic myelomonocytic leukemia (CMML)
- Myelodysplastic syndromes (MDS)
- Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response
You likely can't join if
- Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and...
- Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years
- Pregnant or breastfeeding
- Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide
- Dosing with another investigational agent within 30 days prior to entry in the study
- Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of...
See the full eligibility criteria
- Acute leukemia (AL) that includes acute myeloid leukemia (AML) / acute lymphoblastic leukemia (ALL) / mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual...
- Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor
- Chronic myelomonocytic leukemia (CMML)
- Myelodysplastic syndromes (MDS)
- Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response
- CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
- Low grade lymphoma (chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR/PR
- For CLL/SLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL
- CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
- Large cell lymphoma in \> second CR (CR2)/ \>= PR2
- CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
- Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR/PR
- CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
- For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \ = 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \>= 50% in spleen vertical length...
- Hodgkin Lymphoma in \> CR2/PR2
- CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
- people must be \>= 6 months old
- Karnofsky \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)
- Lansky score \>= 50 (for children)
- Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \>= 40% or shortening fraction \> 22%
- Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:
- Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \>= 70% mm Hg
- DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \>= 70 mm Hg
- DLCO corrected between 50% - 59% mm Hg and pO2 \>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \>= 92% on room air. May not be on supplemental oxygen
- Total bilirubin \< 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- Alkaline phosphatase =\< 5 x ULN
- Creatinine \ 40 ml/min (pediatrics)
- All adults with a creatinine \> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \> 40 ml/min
- If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed
- Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the...
- Written and signed informed consent
- DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should...
- DONOR: Age \>= 12 years
- DONOR: Weight \>= 40 Kg
- DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.
- DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
- DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:
- For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor
- Red blood cell compatibility
- Red blood cell (RBC) cross match compatible
- Minor ABO incompatibility
- Major ABO incompatibility
- Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation
- Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years
- Pregnant or breastfeeding
- Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide
- Dosing with another investigational agent within 30 days prior to entry in the study
- Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiation of conditioning (day -6)
- DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.