Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Stopped early · Phase 2

Conditions studied: Leukemia, Lymphoma, Myeloma, Myeloproliferative Diseases

In brief

The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body. Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants: * Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. * Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die. * Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD). The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.

Key facts

Study ID

NCT01518153

Run by

M.D. Anderson Cancer Center

People needed

16

Starts

2012-02-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 18 years and </= 65 years with one of the following: a. Acute leukemia past first remission, in first or subsequent relapse, in second or greater remission. Patients in first remission should have intermediate or high cytogenetic risk factors or flt3 mutation. Patients with primary induction failure or relapse are eligible if they have <10% bone marrow blasts, and no circulating blasts. b. Myelodysplastic syndrome with intermediate or high risk IPSS score, or treatment related MDS. c. CML resistant to tyrosine kinase inhibitor treatment in a first or subsequent chronic phase, or in accelerated phase. d. CLL, Lymphoma or Hodgkin's disease which has failed to achieve remission or recurred following initial chemotherapy. Patients must have at least a PR to salvage therapy, or low bulk untreated relapse (<2 cm largest mass). e. Multiple myeloma which has relapsed or progressed and has achieved a partial response to salvage chemotherapy.
• Patients must have one of the following donor types identified and willing to donate: a. Related donor, HLA-matched for HLA-A, -B, C and DR matched or, b. Matched Unrelated Donor (MUD), HLA-matched for HLA A, B, C and DRB1 using allele level typing.
• Performance score of at least 80% by Karnofsky or performance score 0 to 2 (ECOG).
• Estimated creatinine clearance >40 ml/min (based on serum creatinine)
• Bilirubin <1.5 mg/dl except for Gilbert's disease.
• ALT < 300 IU/ml d.
• Left ventricular ejection fraction equal or greater than 40%.
• Pulmonary function test (PFT) demonstrating a diffusion capacity (corrected for hemoglobin) of least 50% predicted.
• Patient or patient's legal representative able to sign informed consent.

You may not qualify if…

• Patients who have had prior autologous transplants or prior allogeneic transplants are not eligible.
• Uncontrolled active infection.
• Positive Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
• Women of child bearing potential not willing to use an effective contraceptive measure while on study.
• Subject has known sensitivity to any of the products that will be administered during the study.
• Patients who are HIV seropositive.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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