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

Phase 1
18 Years
75 Years
Not Enrolling
Non Hodgkin's Lymphoma, Hodgkins Disease., Multiple Myeloma

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Trial Information

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

Inclusion Criteria:

1. Patients with chemorefractory non-Hodgkin's or Hodgkin's lymphoma or multiple

Criteria for consideration of enrollment will include:

1. primary refractory or refractory relapsed disease for which autologous HCT is
unlikely to be beneficial;

2. relapse after autologous HCT

3. ineligibility for standard myeloablative or nonmyeloablative allo-HCT because of
either lack of a donor or patient considerations

2. Non Hodgkin's lymphoma, or Hodgkin's lymphoma: primary refractory or refractory

3. Multiple myeloma; primary refractory or refractory relapse

4. Patients with the above malignancies who have had a previous autologous or allogeneic
bone marrow or stem cell transplant.

5. An estimated disease-free survival of less than one year.

6. Age 18 to age < 75 years

7. ECOG performance status of 0, 1, or 2.

Exclusion Criteria:

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

2. 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 will be excluded

3. Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram
determined LVEF ogf< 30%, active angina pectoris or uncontrolled hypertension

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

5. Renal disease: serum creatinine > 3.0 mg/dl.

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

7. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation (pervious CNS
malignancy presently in CR is not an exclusion)

8. Uncontrolled infection.

9. Recipient leukocyte infusion (RLI) might involve the infusion of circulating tumor
cells to the patients. To minimize this risk patients who have evidence of
circulating tumor cells by light microscopy and flow cytometry will be excluded

10. Patients with acute leukemia will be excluded because they will likely have much
greater circulating tumor burden, which would increase the risk of infusion of clonal
tumor cells

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 determine the safety at ≤100 days of a non myeloablative mismatched related HCT when followed by recipient leukocyte infusion to induce deliberate rejection of the donor graft.

Outcome Time Frame:

100 days post transplant

Safety Issue:


Principal Investigator

Bimalangshu R Dey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:

Protocol 07-068



Start Date:

November 2008

Completion Date:

November 2012

Related Keywords:

  • Non Hodgkin's Lymphoma
  • Hodgkins Disease.
  • Multiple Myeloma
  • Related stem cell transplant,
  • TBI,
  • Mismatched stem cell transplant
  • Fludarabine
  • Non-myeloablative
  • Lymphoma
  • Multiple myeloma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Massachusetts General HospitalBoston, Massachusetts  02114-2617