Trials / Completed
CompletedNCT00068718
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant
Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-center Trial
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.
Detailed description
PRIMARY OBJECTIVES: I. To assess the safety of donor lymphocyte infusion (DLI) as adoptive immunotherapy for persistent or relapsed malignant diseases in patients after related or unrelated nonmyeloablative transplantation. SECONDARY OBJECTIVES: I. To determine disease response, progression free and overall survival, chimerism, grade of graft-versus-host disease (GVHD), and infections. OUTLINE: Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. After completion of study treatment, patients are followed up periodically.
Conditions
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Hodgkin Lymphoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Plasma Cell Myeloma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Therapeutic Allogeneic Lymphocytes | Given IV |
Timeline
- Start date
- 2003-05-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2003-09-11
- Last updated
- 2020-01-31
- Results posted
- 2017-03-10
Locations
4 sites across 3 countries: United States, Germany, Italy
Source: ClinicalTrials.gov record NCT00068718. Inclusion in this directory is not an endorsement.