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Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplantation

Phase 2/Phase 3
18 Years
74 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma

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Trial Information

Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplantation

- The first 10 participants (Group 1) will receive a conditioning regimen of total body
irradiation (TBI) before the stem cell transplant. It is possible this conditioning
regimen may suppress the immune system enough. This can cause the stem cell transplant
to be rejected to quickly. It is necessary for the transplant to begin to grow before
it is rejected. If the participants in Group 1 reject their stem cell transplant too
quickly, the next group of 10 participants (Group 2) will receive a medication called
fludarabine for three days before the TBI. The purpose of adding fludarabine is to
suppress the immune system enough to allow the transplant to initially grow. An
additional RLI may be given 2 weeks after the first RLI.

- Before the conditioning regimen (either TBI or fludarabine), participants will undergo
a procedure to collect their white blood cells called leukapheresis. The white blood
cells collected will then be frozen and stored and given to the participant as an RLI
on Day 38 after their stem cell transplant.

- Participants will receive their donor's stem cells about 4-6 hours after TBI. They will
also receive the following medications to prevent GVHD: Cyclosporine orally until about
day 35 and Mycophenolate Mofetil (MMF) orally until 21 days after the stem cell

Inclusion Criteria:

- Chemorefractory non-Hodgkin's or Hodgkin's lymphoma or multiple myeloma

- Estimated disease-free survival of less than one year

- 18-74 years of age

- ECOG Performance Status of 0,1 or 2

Exclusion Criteria:

- Patients whose life expectancy is limited by diseases other than their malignancy

- Patients who have a 5/6 or better matched related donor or a 4/6 or better umbilical
cord blood donor and who are medically eligible for conventional myeloablative or
non-myeloablative transplant

- Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram
determined left ventricular ejection fraction of <30%, active angina pectoris, or
uncontrolled hypertension

- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic
restrictive lung disease, or corrected DLCO of <40% of predicted

- Renal disease: serum creatinine > 3.0mg/dl

- Hepatic disease: serum bilirubin > 3.0mg/dl or alkaline phosphatase, SGOT or SGPT >3x

- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation

- Uncontrolled infection

- RLI might involve the infusion of circulating tumor cells to the patients. To
minimize the risk, patients who have evidence of circulating tumor cells by light
microscopy and flow cytometry will be excluded

- Patients with acute leukemia

Type of Study:


Study Design:

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

Outcome Measure:

To develop a conditioning regimen achieving initial mixed chimerism of HLA-mismatched related donor CD34+ cells without GVHD

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Bimal Dey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachuestts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

June 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • RLI
  • stem cell transplantation
  • fludarabine
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Massachusetts General Hospital Boston, Massachusetts  02114-2617