Neptune City, NJNCT07214688Now EnrollingIRB Ready

Allogeneic Stem Cell Transplant Recipient Clinical Trial in Neptune City, NJ

Access cutting-edge allogeneic stem cell transplant recipient treatment through this phase 2 clinical trial at a research site in Neptune City. Study-provided care at no cost to qualified participants.

Sponsored by Hackensack Meridian Health

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Expert Care in Neptune City

Access allogeneic stem cell transplant recipient specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related allogeneic stem cell transplant recipient treatment provided free

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Check if you qualify for this allogeneic stem cell transplant recipient clinical trial in Neptune City, NJ

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Why Participate?

  • No-Cost Study Care

  • Local to Neptune City

    Convenient for NJ residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Neptune City site if eligible
  4. 4Begin participation

About This Allogeneic Stem Cell Transplant Recipient Study in Neptune City

The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) (experimental regimen) improves the 1-year survival of allogeneic stem cell transplant recipients.

Sponsor: Hackensack Meridian Health

Who Can Participate

Inclusion Criteria

Patients ages 18-65 years.
Patients with a diagnosis of one of the following hematologic malignancies:
Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow;
Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;
Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;
Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria).
Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs.
Patients with a Karnofsky performance status (KPS) of ≥60%.
Patients with adequate organ function defined by:
Cardiac: LVEF ≥50%
Pulmonary: DLCO ≥50% of predicted
Hepatic: Bilirubin ≤1.5x ULN, ALT/AST ≤2.5x ULN
Renal: Creatinine clearance ≥50 mL/min
All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT), the FDA, and other expert bodies.
For Male Participants: ○ Male participants must use effective contraception for at least 12 months after transplant, and longer if receiving immunosuppressive or cytotoxic medications. Chemotherapy and radiation can cause DNA damage to sperm, and even if fertility returns, mutations may persist for months. In cases where drugs such as mycophenolate mofetil (MMF) or lenalidomide are used, FDA guidance requires contraception for at least 90 days after discontinuation. Sperm cryopreservation should be offered prior to conditioning. Participants must avoid fathering a child during this time frame.15-17
For Female Participants:
Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy. For drugs such as MMF, sirolimus, or ruxolitinib, contraception must continue for 3 months after the last dose.
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.15-17
Patients with a suitable donor for allogeneic stem cell transplant defined by:
Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation;
Unrelated donors at \>7/8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor Program criteria; or Related Haploidentical donors willing to donate PBSC or BM and meeting criteria for donation.
Patients who are able to comply with follow-up visits and treatment plans.
Patients who are able to give informed consent.

Exclusion Criteria

Hematopoietic cell transplantation comorbidity index above 3.
Patients with a Karnofsky performance status (KPS) of \<60%.
Patients with active infections or other contraindications for allogeneic stem cell transplant.
Patients who are unable or unwilling to give informed consent.
Patients who have received a prior allogeneic transplant.
Patients who are unable to comply with follow-up visits and treatment plans.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Neptune City?

Yes, this clinical trial (NCT07214688) has an active research site in Neptune City, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Allogeneic Stem Cell Transplant Recipient Treatment Options in Neptune City, NJ

If you're searching for allogeneic stem cell transplant recipient treatment options in Neptune City, NJ, this clinical trial (NCT07214688) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Neptune City research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced allogeneic stem cell transplant recipient specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all allogeneic stem cell transplant recipient clinical trials near you to find additional studies recruiting in your area.

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