Bone Marrow Transplant
| Status | Conditions | Phase | Study ID |
| Closed | Acute Lymphoid Leukemia (ALL) Acute Myeloid Leukemia (AML) Chronic Myeloid Leukemia (CML)Hodgkin's Lymphoma Juvenile Myeloid Leukemia (JML) Leukemia Lymphoma Multiple Myeloma (MM) Non-Hodgkin's Lymphoma (NHL) |
Phase I/II |
FHCRC-1803 NCT00068718 |
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back after a donor hematopoietic cell transplant. PURPOSE: This clinical trial studies donor lymphocyte infusion in treating patients with persistent, relapsed, or progressing cancer after donor hematopoietic cell transplantation
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Only patients having received a preceding nonmyeloablative allogeneic transplantation with fludarabine/2 Gy total-body irradiation (TBI) - 4 Gy TBI or 2 Gy TBI - 4 Gy TBI conditioning from either a related or unrelated donor are eligible for this protocol
- Patients with persistent, relapsed or progressing malignancy after nonmyeloablative allogeneic transplantation (persistent disease will be defined as a failure to achieve a response as compared to baseline)
- Patients with rapidly progressing malignancies (acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), blastic phase chronic myelogenous leukemia (CML-BC), intermediate-high-grade non-Hodgkin lymphoma (NHL), Hodgkins disease or aggressive multiple myeloma (MM)) should receive salvage chemotherapy or radiation before DLI according to the recommendation made in this protocol; any form of salvage chemotherapy should be discontinued no less than 3 weeks before DLI; therapy with Gleevec or IFN-alpha should be discontinued prior to DLI; after salvage chemotherapy restaging is performed, patients with progressive disease and patients not meeting the inclusion criteria of the study after chemotherapy will be excluded from the study; patients are allowed to receive further doses of chemotherapy after DLI administration if they are scheduled for further DLI; after additional therapy the patients must be restaged and must again meet inclusion criteria to receive further DLI
- Patients must be able to tolerate a taper of systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day; all other immunosuppressive therapy must have been discontinued for at least two weeks without significant flares in GVHD (i.e., increase of acute GVHD by one or more grades)
- Patients must have persistent donor CD3 cells (> 5% donor CD3 cells by a DNA-based assay that compares the profile of amplified fragment length polymorphisms [ampFLP or FISH studies or VNTR])
- DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the DLI product must be from the original donor of hematopoietic cell transplantation
- DONOR: Original donor of hematopoietic cell transplantation
- DONOR: Donor must give consent to leukapheresis
- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
- DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional guidelines for apheresis)
Exclusion Criteria:
- Current grade II to IV acute GVHD or extensive chronic GVHD
- Karnofsky score < 50%
- Lansky Play-Performance Score < 40 for pediatric patients
- DONOR: Donors who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
- DONOR: Pregnancy
- DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection
- DONOR: Recent immunization may require a delay
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.
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