Washington Dc, DCNCT02203903Now EnrollingIRB Ready

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS Clinical Trial in Washington Dc, DC

Access cutting-edge relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds treatment through this clinical trial at a research site in Washington Dc. Study-provided care at no cost to qualified participants.

Sponsored by Catherine Bollard

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Expert Care in Washington Dc

Access relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds treatment provided free

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Check if you qualify for this relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds clinical trial in Washington Dc, DC

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Why Participate?

  • No-Cost Study Care

  • Local to Washington Dc

    Convenient for DC 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 Washington Dc site if eligible
  4. 4Begin participation

About This Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS Study in Washington Dc

This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.

Sponsor: Catherine Bollard

Who Can Participate

Inclusion Criteria

to Enter Protocol:
Aged 6 months to 80 years.
Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant.
Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease.
Karnofsky/Lansky score of ≥ 50.
Agree to use contraceptive measures during study protocol participation (when age appropriate).
Patient or parent/guardian capable of providing informed consent.
T cell chimerism \> 94% if collected from recipient of allo-HSCT Recipient

Exclusion Criteria

to Enter Protocol:
Patients with uncontrolled infections.
Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
Pregnancy (female of childbearing potential). Recipient Inclusion Criteria for TAA-T Administration:
Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease.
Steroids less than 0.5 mg/kg/day prednisone or equivalent in the context of no escalation of treatment within the preceding 2 weeks
Karnofsky/Lansky score of ≥ 50.
Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher).
Pulse oximetry of \> 90% on room air.
Absolute neutrophil count \> 250/ µL (may be supported with Granulocyte colony-stimulating factor (GCSF)).
Agree to use contraceptive measures during study protocol participation (when age appropriate).
Patient or parent/guardian capable of providing informed consent.
LVEF \> 50% or LVSF \> 27% (performed within the last 6 months) if history of TBI \>500 cGy for arm A and B.
Total chimerism \> 50%; or if cancer cells preclude this, donor T cell chimerism \> 50% (performed within the last 6 months). Recipient Exclusion Criteria for TAA-T Administration:
Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T infusion.
No investigational therapies (under IND, not extensively studied in the current clinical context) within 28 days prior to TAA-T infusion.
Uncontrolled infections.
Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
Active acute GVHD or chronic GVHD requiring escalation of treatment within preceding 2 weeks of any grade is exclusion for Arm C patients.
Pregnancy or lactating (female of childbearing potential).
Patients who have or will be receiving 2nd allogeneic HSCT Donor Inclusion Criteria:
Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation.
Aged 6 months to 80 years.
Donor or guardian of pediatric capable of providing informed consent.
Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed:
HB Core antibody
Syphilis (T. Pallidum IgG)
HBV/HCV NAT
West Nile Virus NAT.
Cruz (Chagas) antibody
Hepatitis C
Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing. Donor Exclusion Criteria:
Donation of cells would pose a physical or psychological risk to the donor.
Female donors of childbearing age who are known to be pregnant.

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 Washington Dc?

Yes, this clinical trial (NCT02203903) has an active research site in Washington Dc, DC 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.

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS Treatment Options in Washington Dc, DC

If you're searching for relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds treatment options in Washington Dc, DC, this clinical trial (NCT02203903) 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 Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds 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 relapsed/refractory hematopoietic malignancies, acute myeloid leukemia and mds clinical trials near you to find additional studies recruiting in your area.

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