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Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders


Phase 2
18 Years
55 Years
Not Enrolling
Both
Allogeneic Stem Cell Transplant, Leukemia, Non-Hodgkins, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Information

Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders


The purpose of this study is: (1) to try to kill any cancer or precancer cells that are in
your body, and to reduce the side effects of a transplant, which we have seen in our
previous studies, (2) to see if this treatment with a new recipe of radiation and
chemotherapy can suppress your immune system enough for the stem cells to 'take' and grow,
(3) to see if the specially prepared stem cells can grow in you without a problem called
graft-versus-host disease (GvHD) occurring.

One of the major side effects of any stem cell transplant is a condition known as graft vs.
host disease or GVHD. GVHD is an immune reaction caused by certain cells from the
transplanted stem cells called T-lymphocytes (or T-cells). The T-cells from your donor may
see your organs as foreign and attack them. New ways to remove the T-cells from the stem
cells before the transplant are being used to try and prevent GVHD. In some studies, the
removal of T-cells from the stem cells has been successful for many patients in preventing
both short-term (acute) and long-term (chronic) forms of GVHD. However, the removal of
T-cells may increase the chance that the new bone marrow developing from the stem cells will
be rejected or will not function well. Rejection of the transplant means that some of your
own cells have survived the chemo and radiation therapy, and are attacking the new bone
marrow cells. This condition can be lifethreatening because of an increased risk of
infections and bleeding and would require your getting more treatment and additional stem
cells. Studies like this one are designed to find better ways to avoid GVHD without
increasing the risk of other problems such as graft rejection.


Inclusion Criteria:



- Histologically proven acute or chronic leukemia, non Hodgkins and lymphoblastic
lymphoma or myelodysplastic syndrome

- HLA 6/6 or 5/6 antigen matched related or unrelated donor

- creatinine = normal or if not, CrCl > 60 ml/min/1.73ml

- total bilirubin < 2.5, AST < 2xnl, cardiac function > 50%

- pulmonary function - asymptomatic or if not DLCO > %50% (corrected for Hgb)

- Karnofsky performance status > 70%

- negative pregnancy test (where applicable)

- signed informed consent of patient and donor.

Exclusion Criteria:

- Pregnancy or lactation

- unwillingness to comply with protocol treatment or follow-up

- uncontrolled infection

- HIV or HTLV positivity

- active CNS/skin disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the impact of a novel cytoreductive regimen followed by allogeneic stem cell transplant on transplant related morbidity and mortality.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Ann Jakubowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

01-070

NCT ID:

NCT00587054

Start Date:

June 2001

Completion Date:

May 2011

Related Keywords:

  • Allogeneic Stem Cell Transplant
  • Leukemia
  • Non-Hodgkins
  • Lymphoblastic Lymphoma
  • Myelodysplastic Syndrome
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • leukemia
  • non-Hodgkins
  • lymphoblastic lymphoma
  • myelodysplastic syndrome
  • paroxysmal nocturnal hemoglobinuria (PNH)
  • cytoreductive regimen
  • allogeneic stem cell transplant
  • Hemoglobinuria
  • Leukemia
  • Lymphoma
  • Hemoglobinuria, Paroxysmal
  • Myelodysplastic Syndromes
  • Preleukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021