BridgeMD
New treatment option for Hematologic Neoplasms
Official title Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
ClinicalTrials.gov ID: NCT04959175
What this study is testing
What is Mycophenolate Mofetil?
Mycophenolate Mofetil is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hematologic neoplasms.
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: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 months
- 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 85. Healthy volunteers may be eligible.
You may be able to join if
- -- Recipient
- people must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell...
- Acute myeloid leukemia in morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no...
- B-cell acute lymphoblastic leukemia in first or subsequent complete remission
- T-cell acute lymphoblastic leukemia in first or subsequent complete remission
You likely can't join if
- Recipient:
- people who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date...
- Poorly controlled malignant indication for transplantation such as:
- Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \>5% or active extramedullary disease)
- Lymphoma not having achieved at least a partial response to prior chemotherapy or radiation
- Uncontrolled intercurrent illness that in the opinion of the site PI would make it unsafe to proceed with transplantation.
See the full eligibility criteria
- -- Recipient
- people must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:
- Acute myeloid leukemia in morphologic complete remission (\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)
- B-cell acute lymphoblastic leukemia in first or subsequent complete remission
- T-cell 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, 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 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 higher60 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 60-85 years, or age 18-60 years and unfit for myeloablative conditioning. Reasons for unfitness for myeloablative conditioning include:
- Prior myeloablative HCT
- Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome.
- Significant organ dysfunction (e.g., creatinine or liver enzymes above the upper limit of normal or EGFR \<=70 ml/min/1.73sq.m; prior sinusoidal obstruction syndrome, hepatic fibrosis, hepatic steatosis, or nodular...
- Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \>= 3
- Subject refusal of MAC (including people insistent on trying to maintain fertility)
- Pre-frail or frail by Fried s frailty phenotype
- Karnofsky performance score \<80
- Significant life-threatening toxicities associated with prior chemotherapy
- Co-morbidity considered by the treating physician to be exclusionary of MAC
- At least one potentially suitable HLA-matched related, HLA-haploidentical first degree or collateral related, HLA-matched unrelated, or \>=5/10 HLA-mismatched unrelated donor.
- Karnofsky performance score \>=60
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Adequate organ function defined as possessing all of the following:
- Cardiac ejection fraction \>=35%;
- Forced expiratory volume-1, forced vital capacity, and diffusing capacity of the lung for carbon monoxide (corrected for hemoglobin) all of \>=40% predicted;
- Serum creatinine clearance of \>=45 ml/minute calculated using the Cockcroft-Gault equation;
- Total bilirubin \<=2X the upper limit of normal;
- Alanine aminotransferase and aspartate aminotransferase \<=5X the upper limit of normal.
- Nonmyeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:
- Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-transplant.
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
- For NIH treated people only: people requiring standard therapies to prepare for HCT should be referred in remission, if possible. However, these diseases are often aggressive and require swift evaluation for HCT while...
- Recipient:
- people 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.
- Poorly controlled malignant indication for transplantation such as:
- Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \>5% or active extramedullary disease)
- Lymphoma not having achieved at least a partial response to prior chemotherapy or radiation
- Uncontrolled intercurrent illness that in the opinion of the site PI would make it unsafe to proceed with transplantation.
- The potential for some of the study medications to be transmissible via breast milk of nursing mothers is unknown. Because there is unknown but potential risk for adverse events in nursing infants secondary to treatment...
- Active malignancy of non-hematopoietic type which is: metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease treated with curative intent treatment...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Philadelphia, 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 study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Philadelphia, 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.