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Compares treatment options for Hematologic Malignancies
Official title A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
ClinicalTrials.gov ID: NCT07359859
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for hematologic malignancies.
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
- The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
- 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 18 and older
You may be able to join if
- Patients ≥18- years-old at time of consent
- Diagnosis: hematologic malignancy in morphologic remission (blasts \<5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with...
- Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky score ≥ 70%
- Female people of childbearing potential (\<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined...
You likely can't join if
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately...
- Severely impaired renal function defined by serum creatinine \> 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic...
See the full eligibility criteria
- Patients ≥18- years-old at time of consent
- Diagnosis: hematologic malignancy in morphologic remission (blasts \<5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are...
- Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky score ≥ 70%
- Female people of childbearing potential (\<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of...
- For male people who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at...
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and...
- Severely impaired renal function defined by serum creatinine \> 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within...
- Uncontrolled psychiatric illness
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 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.