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Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants


N/A
10 Years
80 Years
Open (Enrolling)
Both
Stem Cell Transplantation, Transplantation, Homologous, Allogenic Stem Cell Transplant Recipient

Thank you

Trial Information

Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants


While patients surviving more than three years from SCT have a high probability of being
cured of their underlying disease, they are still at risk from several categories of
complications which could remain lifelong risks including late recurrence (or continued
persistence) of original disease, late effects from transplant related GVHD, immune
dysfunction, or consequences from the chemotherapy and/or radiation given during transplant
conditioning.

Since these complications are iatrogenic, the long term follow-up of SCT patients is the
ethical responsibility of the transplant team. In addition, collecting data on late
occurring complications allows for prospective evaluation of the long term consequences of
surviving a particular transplant treatment approach (i.e. total body irradiation versus
chemotherapy conditioning, T cell depleted versus T cell replete transplants).

This protocol is designed to allow for long term evaluation, data collection, and when
needed standard medical care of patients (and when appropriate their stem cell donor) who
have received allogeneic stem cell transplantation in NHLBI protocols. This may include
patients with bone marrow failure states, cytopenias, hemoglobinopathies, metastatic solid
tumors, or hematologic malignancies.

No investigational treatments will be administered on this protocol. Participation will not
constitute a promise of long-term medical care at the NIH, nor will it provide for the
evaluation and treatment of any non-transplant related medical problems. This protocol will
provide access to NIH hematologists experienced in the care of post transplant patients who
can help transplant patients and their local physician manage post transplant complications.
In return, data collected from subjects and their donors (when applicable) will provide NIH
researchers valuable information and/or laboratory samples for the purposes of better
understanding the long term consequences of stem cell transplantation and identifying areas
in need of future research.

Inclusion Criteria


- INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:

Patients surviving three years or more from date of first stem cell transplant who have
been treated.

-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol

Or

-With a standard of care allogeneic stem cell transplant on the NHLBI standard of care
protocol

Or

-As a special exemption to the above protocols

Age greater than or equal to 10 years old and age less than or equal to 80

For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian and
informed assent: The process will be explained to the minor on a level of complexity
appropriate for their age and ability to comprehend.

EXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:

None, all patients meeting the inclusion criteria will be eligible

INCLUSION CRITERIA-DONOR:

If appropriate clinical management of the recipient or ongoing laboratory research would
indicate the need for additional stem cell collection or peripheral blood collection, a
donor may also be accrued to this protocol providing they meet the following criteria:

- HLA 5/6 or 6/6 matched family donor

- Weight greater than or equal to 18 kg

- Age greater than or equal to 2 or less than or equal to 80 years old

- Age greater than or equal to 18 years of age (if participating only as a donor of
peripheral blood cells for laboratory research studies).

- For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian
and informed assent: The process will be explained to the minor on a level of
complexity appropriate for their age and ability to comprehend.

No additional stem cells will be harvested for research purposes.

EXCLUSION CRITERIA-DONOR (ANY OF THE FOLLOWING):

- Pregnant or actively breastfeeding

- Donor unfit to receive filgrastim and undergo apheresis. (Uncontrolled hypertension,
history of congestive heart failure or unstable angina, thrombocytopenia)

- HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the
risk-benefit ratio is considered acceptable by the patient and investigator.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Minocher M Battiwalla, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

050130

NCT ID:

NCT00106925

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Stem Cell Transplantation
  • Transplantation, Homologous
  • Allogenic Stem Cell Transplant Recipient
  • Late Effects
  • Peripheral Blood Stem Cell Transplant
  • PBSCT
  • Allogeneic Stem Cell Transplant
  • Peripheral Blood Stem Cells
  • Graft-Versus Leukemia/Myeloma
  • Graft-Versus-Host Disease
  • Whole Body Irradiation
  • Leukemic Relapse
  • Graft Rejection
  • Allogeneic Stem Cell Transplantation Recipient

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892