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New treatment option for Hematologic Neoplasms
Official title Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
ClinicalTrials.gov ID: NCT05327023
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 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: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- 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
- Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for...
- Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first...
- AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate...
- AML with adverse cytogenetics (complex karyotype with \>= 4 abnormalities) regardless of remission status
You likely can't join if
- Exclusion Criteria - Recipient
- people who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date...
- Prior myeloablative conditioning for autologous or allogeneic HCT.
- Active breastfeeding.
- Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally...
- Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active...
See the full eligibility criteria
- - Recipient
- Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:
- Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse
- AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission [CR] with minimal residual...
- AML with adverse cytogenetics (complex karyotype with \>= 4 abnormalities) regardless of remission status
- Low risk myelodysplastic syndrome (MDS) (\ = 4 abnormalities) with induction failure or active relapse
- High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or \< 4 abnormalities) with induction failure or active relapse
- High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or \>= 4 abnormalities) regardless of remission status
- Acute lymphoblastic leukemia (ALL) in CR \>= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)
- Chronic myelocytic leukemia (CML) in blast crisis phase
- Hodgkin lymphoma with stable or progressive disease
- Mantle cell lymphoma with stable or progressive disease
- Relapsed Burkitt lymphoma in CR or partial remission (PR)
- Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease
- T-cell NHL with stable or progressive disease
- Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response [VGPR], or PR) or the development of progressive disease on primary therapy, or MM with...
- Age 18-65 years.
- At least one potentially suitable HLA-haploidentical or HLA-matched donor
- Karnofsky performance score \>=60%
- Recipient participants must have adequate organ function as defined below:
- 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/1.73m2 calculated using eGFR in the clinical lab;
- Total bilirubin \<=2X the upper limit of normal;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=3X the upper limit of normal.
- Myeloablative 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 highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant.
- WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.
- Donor -Related donor (age \>=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be...
- Exclusion Criteria - Recipient
- people who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.
- Prior myeloablative conditioning for autologous or allogeneic HCT.
- Active breastfeeding.
- Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes...
- Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI...
The study team makes the final eligibility decision.
Where it's taking place
- 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 study runs about 5 years 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 120 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. 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.