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Compares treatment options for Peripheral Blood Stem Cell Transplantation
Official title The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05436418
What this study is testing
What is Melphalan?
Melphalan is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for peripheral blood stem cell transplantation.
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
- Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers.
- 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 12 to 120. Healthy volunteers may be eligible.
You may be able to join if
- Recipient
- Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell...
- Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete...
- AML of any risk in second or subsequent morphologic complete remission
- Acute lymphoblastic leukemia in first or subsequent complete remission
You likely can't join if
- Recipient
- Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the...
- Active nursing.
- Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is: metastatic, or relapsed/refractory to treatment, or...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.
- Uncontrolled intercurrent illness (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active...
See the full eligibility criteria
- Recipient
- Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following:
- Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral...
- AML of any risk in second or subsequent morphologic complete remission
- Acute lymphoblastic leukemia in first or subsequent complete remission
- Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)
- Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS
- Chronic myelomonocytic leukemia
- Chronic myelogenous leukemia resistant to or intolerant of \>= 3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis
- B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, relapsed after autologous transplantation, or has progressed through at least 2 lines of therapy
- Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV or refractory to or intolerant of both BTK and PI3K inhibitors
- Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on the Prognostic Index for T-cell lymphoma (PIT) score of low-intermediate risk or higher or on...
- Hematologic malignancy of dendritic cell or histiocytic cell type
- Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)
- Age \>= 50 years or age 18-49 years and also meeting one of the following criteria:
- Prior myeloablative HCT
- Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome.
- Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \>= 3
- Karnofsky performance score \<80
- Co-morbidity considered by the treating physician to be exclusionary of myeloablative conditioning
- At least one potentially suitable HLA-haploidentical or 10/10 (HLA-A, B, C, DR, DQ) related or unrelated donor for HCT
- Karnofsky performance score \>= 70
- Adequate organ function defined as possessing all of the following:
- Cardiac ejection fraction \>= 45% by 2D ECHO;
- Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \>= 50% predicted;
- Estimated serum creatinine clearance of \>= 60 ml/minute/1.73m\^2 calculated using eGFR in the clinical lab;
- Total bilirubin \<= 2X the upper limit of normal;
- Alanine aminotransferase and aspartate aminotransferase \<= 3X the upper limit of normal.
- Individuals of child-bearing potential (IOCBP) and participants who can father children must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and...
- IOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiation of conditioning regimen.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Recipient
- Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.
- Active nursing.
- Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is: metastatic, or relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.
- Uncontrolled intercurrent illness (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active infectious hepatitis, uncontrolled dental infection) that in the opinion...
- Related (age \>=12) and unrelated (age \>=18) donors deemed eligible (i.e., evaluated at NIH, COH, and FHCC in accordance with existing institutional Standard Policies and Procedures or evaluated per the standards...
- Ability of participant or parent/legal guardian to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: Donor None
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Bethesda, Maryland, 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, 12 years to 120 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Bethesda, Maryland, 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.