T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

Stopped early · Phase 2

Conditions studied: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Myelodysplastic Syndromes, Precancerous/Nonmalignant Condition, Secondary Myelofibrosis

In brief

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant followed by delayed T cell infusions in treating patients with hematologic cancer or other disease.

Key facts

Study ID

NCT00589602

Run by

The Cleveland Clinic

People needed

13

Starts

2004-01-01

Expected to finish

2014-12-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient actual weight must not be greater than 1.5x their ideal body weight
• Cardiac ejection fraction >45%. If less than 45%, a Cardiac consult will be obtained.
• A suitably matched unrelated donor that is at least a 7 out of 8 HLA serologic match.
• Patient is not pregnant.
• FEV 1 and DLCO > 45% predicted on pulmonary function testing.
• Serum creatinine <2.0 mg/dl, serum bilirubin <2.0 mg/dl.
• Patient and donor are HIV negative.
• Diagnosis of one of the following diseases
• Acute myelogenous leukemia
• Relapsed disease,
• Refractory disease, or
• With poor-risk cytogenetics
• Acute lymphoblastic leukemia
• Relapsed disease,
• Refractory disease, or
• With poor-risk cytogenetics
• Chronic myelogenous leukemia
• Persistent disease after at least 6 months of treatment with Imatinib Mesylate (Gleevec)
• Myelodysplasia
• FAB Classification of RAEB or RAEB-T -Or-
• IPSS score >2
• Lymphoid malignancies, including non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia and prolymphocytic leukemia
• Relapsed or refractory disease after at least 1 prior therapy
• Myelofibrosis
• Transfusion dependence (RBC's, platelets, or both)

You may not qualify if…

• Inability to give informed consent
• Absence of any of the above mentioned medical conditions
• Availability of matched-related donor
• History of prior allogeneic BMT

Where it is running

• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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