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

Last updated: May 3, 2010
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Multiple Myeloma

Lymphoma

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT00981760
07-068
  • Ages 18-74
  • Both

Study Summary

One risk of a stem cell transplant is that the donated stem cells do not grow in the recipient. This is called graft rejection. Previous laboratory research has suggested that the reaction between the recipient's cells and the donor's cells that causes graft rejection is associated with an anti-cancer effect. In this research study the investigators will give participants some of their own white blood cells after their transplant. This is called a recipient leukocyte infusion (RLI). This is done to cause the participant's immune system to react against the donor's cells and reject the transplant. The purpose of this research study is to learn if the graft rejection has an anti-cancer effect.

Eligibility Criteria

Inclusion

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

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 umbilicalcord blood donor and who are medically eligible for conventional myeloablative ornon-myeloablative transplant

  • Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogramdetermined left ventricular ejection fraction of <30%, active angina pectoris, oruncontrolled hypertension

  • Pulmonary disease: severe chronic obstructive lung disease, or symptomaticrestrictive 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 >3xnormal

  • Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or otherneuropsychiatric abnormalities believed to preclude transplantation

  • Uncontrolled infection

  • RLI might involve the infusion of circulating tumor cells to the patients. Tominimize the risk, patients who have evidence of circulating tumor cells by lightmicroscopy and flow cytometry will be excluded

  • Patients with acute leukemia

Study Design

Total Participants: 20
Study Start date:
July 01, 2008
Estimated Completion Date:
June 30, 2010

Study Description

  • 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 transplant.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02214
    United States

    Active - Recruiting

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