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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


Phase 1
18 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Lymphoblastic Leukemia, Acute Leukemia, Non Hodgkins Lymphoma, Chronic Myeloid Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the overall toxicity and day 100 transplant related mortality

Outcome Time Frame:

Up do 100 days post-transplant

Safety Issue:

Yes

Principal Investigator

Damiano Rondelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois

Authority:

United States: Institutional Review Board

Study ID:

2009-0251

NCT ID:

NCT00988013

Start Date:

September 2009

Completion Date:

September 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • Lymphoblastic Leukemia
  • Acute Leukemia
  • Non Hodgkins Lymphoma
  • Chronic Myeloid Leukemia
  • total marrow irradiation
  • intensity modulated radiation
  • leukemia
  • hematologic diseases
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Hematologic Neoplasms

Name

Location

University of Illinois at ChicagoChicago, Illinois  60612