Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 5/5/2014 |
| Start Date: | September 2009 |
| End Date: | September 2016 |
| Contact: | Damiano Rondelli, MD |
| Email: | drond@uic.edu |
| Phone: | (312) 996-6179 |
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in
addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for
advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high
grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell
leukemia. Because the subjects participating in this study have a disease that is severe
and has a high risk of relapse even after transplant, the investigators propose to use a
chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy
drugs that is given to patients prior to transplantation of the donor stem cells, along with
intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in
conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to
bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can
cause severe side effects due to irradiation of organs such as the lenses of the eye, whole
brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the
delivery of adequate doses of radiation to the bone marrow while sparing other organs and
therefore limiting radiation side effects. The irradiation, along with receiving the
chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but
will also intensify the effect of the conditioning regimen thus allowing the bone marrow
transplantation to have a greater chance of being successful.
No investigational drugs are used in this study. The investigational part of this study is
the use of intensity modulated total marrow irradiation instead of conventional radiation.
IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the
doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for
advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high
grade non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell
leukemia. Because the subjects participating in this study have a disease that is severe
and has a high risk of relapse even after transplant, the investigators propose to use a
chemotherapy regimen (fludarabine/busulfan), the name for the combination of chemotherapy
drugs that is given to patients prior to transplantation of the donor stem cells, along with
intensity modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in
conjunction with chemotherapy is a standard of care as a pre-conditioning regimen prior to
bone marrow transplant (BMT) in patients with hematologic malignancies. However, TBI can
cause severe side effects due to irradiation of organs such as the lenses of the eye, whole
brain, lungs, liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the
delivery of adequate doses of radiation to the bone marrow while sparing other organs and
therefore limiting radiation side effects. The irradiation, along with receiving the
chemotherapy drugs will suppress the subject's immune system and kill off tumor cells, but
will also intensify the effect of the conditioning regimen thus allowing the bone marrow
transplantation to have a greater chance of being successful.
No investigational drugs are used in this study. The investigational part of this study is
the use of intensity modulated total marrow irradiation instead of conventional radiation.
IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the
doses of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
Inclusion Criteria:
- Patients with the following diseases:
- Acute myeloid or lymphoblastic leukemia in first complete remission if poor
prognosis documented by failure to response after initial induction
chemotherapy, or cytogenetic, or molecular studies.
- Acute leukemia in greater/equal second remission, or partial remission after
chemotherapy.
- High grade non Hodgkin's or Hodgkin's lymphoma with marrow involvement
resistant/ relapsed after second line therapy including high dose chemotherapy
and autologous SCT.
- CML in advanced or blastic phase.
- Plasma cell leukemia.
- Age 18-60 years.
- Karnofsky performance status of 70
- Adequate cardiac and pulmonary function. Patients with decreased LVEF less than/equal
to 40% or DLCO less than/equal to 50% of predicted will require clearance from
cardiology or pulmonary services, respectively, prior to enrollment on this protocol.
- Serum creatinine less than/equal to 1.5 mg/dL or Creatinine Clearance greater
than/equal to 50 ml/min .
- Serum bilirubin 2.0 mg/dl, SGPT less than/equal to 3 times the upper limit of normal
Exclusion Criteria:
- Life expectancy is severely limited by concomitant illness.
- Evidence of chronic active hepatitis or cirrhosis
- HIV-positive
- Patient is pregnant
- Patient or guardian is not able to sign informed consent.
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