TerminatedPhase 2

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers

Stopped: Premature closure due to inability to accrue to ARM IVD, cohorts 1 and 2

United States442 participantsStarted 2004-01-01

Plain-language summary

Background: Patients with cancers of the blood and immune system often benefit from transplants of stem cells from a genetically well-matched sibling. However, severe problems may follow these transplants because of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune cells sometimes attack healthy tissues in a reaction called graft-versus-host disease (GVHD), damaging organs such as the liver, intestines and skin. To reduce toxicity of high-dose preparative chemotherapy, this study performs allogeneic transplant after low doses of chemotherapy. In an attempt to improve anti-tumor effects without increasing GVHD, this study uses donor immune cells (T helper 2 (Th2) cells) grown in the laboratory; some patients will receive standard donor immune cells (not grown in laboratory). All patients will receive immune modulating drugs sirolimus and cyclosporine to prevent GVHD. Objective: To determine the safety, treatment effects and rate of GVHD in patients receiving transplants that use low-intensity chemotherapy, sirolimus plus cyclosporine, and transplant booster with either Th2 cells or standard immune cells. Eligibility: Patients 16 to 75 years of age with acute or chronic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, multiple myeloma, or myelodysplastic syndrome. Patients must have a suitable genetically matched sibling donor and adequate kidney, heart and lung function. Design: The protocol has three treatment groups: cohort 1, Th2 booster at two weeks post-transplant; cohort 2, standard T cell booster at two weeks post-transplant; cohort 3, multiple infusion of Th2 cells. Condition: Hematologic Neoplasms, Myeloproliferative Disorders Intervention: Biological; therapeutic allogeneic lymphocytes Drug: Sirolimus Study Type: Interventional Study Design: Primary Purpose: Treatment Phase: Phase II

Who can participate

Age range11 Years – 90 Years

SexALL

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Inclusion criteria

✓. Patients with hematologic malignancies, myelodysplasia, or myeloproliferative disorders, as summarized in the following table. The diagnosis must be histologically confirmed by the Laboratory of Pathology of National Cancer Institute (NCI) or Hackensack (There will be no central pathology review).
✓. Chronic Lymphocytic Leukemia - Disease Status: a) Relapse post-fludarabine, b) Non-Complete Response (CR) after salvage regimen.
✓. Patient age of 16 to 75 years.
✓. Consenting first degree relative matched at 6/6 HLA antigens (A, B, and DR).
✓. Patient or legal guardian must be able to give informed consent.
✓. All previous intravenous therapy administered outside of the National Institutes of Health (NIH) Clinical Center must be completed at least 2 weeks prior to study entry, with recovery to less than or equal to non-hematologic grade 2 toxicity of previous therapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance status equal to 0 or 1.
✓. Life expectancy of at least 3 months.

Exclusion criteria

What they're measuring

Percentage of Patients to Receive T Cell Infusion

Timeframe: first 100 days post-transplant

Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)

Timeframe: first 100 days post-transplant

Trial details

NCT IDNCT00074490

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2017-07-20

Results submitted2018-10-22

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