NCT Number: NCT00248430
Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant using the patient's stem cells may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may stimulate the white blood cells to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell infusions and interleukin-2 and to see how well they work in treating patients who are undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–69 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
About this study
OBJECTIVES:
Primary
- Determine the feasibility and toxicity of haploidentical related donor lymphocyte infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft failure, and transplant-related mortality, in patients with relapsed advanced lymphoid malignancies undergoing autologous stem cell transplantation.
Secondary
- Determine the extent, degree, and duration of donor chimerism in patients treated with this regimen.
- Determine, preliminarily, activity of haploidentical DLI, as measured by complete response rate, in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous stem cell transplantation on day 0. Patients receive haploidentical related donor lymphocyte infusions (DLI) IV on days 1, 5*, and 10* and interleukin-2 (IL-2) IV continuously on days 1-12.
NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is present
After completion of study treatment, patients are followed monthly for 3 months and then every 3-12 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following advanced lymphoid malignancies:
- Multiple myeloma, meeting both of the following criteria:
- Deletion of chromosome 13
- Elevated pre-transplant lactic dehydrogenase
- Chronic lymphocytic leukemia (CLL)
- Failed ≥ 2 prior conventional chemotherapy regimens, including fludarabine
- Small lymphocytic lymphoma
- Follicular non-Hodgkin's lymphoma
- Received ≥ 3 prior conventional chemotherapy regimens
- Mantle cell lymphoma
- Received ≥ 3 prior conventional chemotherapy regimens
- Predicted poor outcome and relapsed disease after undergoing autologous stem cell transplantation ≥ 6 months ago
- Measurable disease, defined as any evidence of disease by scans or blood or urine analysis
- At least 8 x 10^6 autologous CD34-positive cells/kg available for transplantation
- Stem cell mobilization allowed
- Haploidentical related donor available
- Sex-mismatched
- Identical for 1 HLA haplotype AND mismatched for ≥ 1 HLA-A, -B, -C, or DRB1 locus of the unshared haplotype
- No HLA-identical related or unrelated donor available
- Not eligible for first-line autologous stem cell transplantation on protocol FHCRC-1368.00, FHCRC-1366.00, FHCRC-1461.00, or FHCRC-1595.00
- No bulky disease, defined as total volume of all measurable tumor > 500 cc
- No CNS disease resistant to therapy
PATIENT CHARACTERISTICS:
Age
- 18 to 69
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Liver function tests or liver enzymes ≤ 2 times upper limit of normal
Renal
- Not specified
Cardiovascular
- Ejection fraction ≥ 45%
- No symptomatic cardiac disease
Pulmonary
- DLCO ≥ 50%
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV Negative
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent contrast dye during and for 3 weeks after completion of interleukin-2 administration
Treatment and study plan
therapeutic allogeneic lymphocytes
Biologicalmelphalan
Drugbone marrow ablation with stem cell support
Procedureperipheral blood stem cell transplantation
ProcedurePrimary outcomes
-
Feasibility
-
Toxicity
Secondary outcomes
-
Extent, degree, and duration of donor chimerism
-
Complete response rate
Sponsors and collaborators
Lead sponsor
Fred Hutchinson Cancer Center
Other
Registry information
Official study title
A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies
Important dates
- Study start
- 2003
- Study completion
- 2007
- First posted
- Nov 4, 2005
- Registry last updated
- Sep 21, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
NCT00611351
Blast Crisis, Blood Protein Disorders
Omaha, Nebraska, United States
View Trial DetailsChemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
NCT00003270
Blast Crisis, Blood Protein Disorders
Buffalo, New York, United States
View Trial DetailsBone Marrow Transplantation in Treating Patients With Hematologic Cancer
NCT00003398
Anemia, Blast Crisis
Baltimore, Maryland, United States
View Trial DetailsRasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant
NCT00513474
Blast Crisis, Blood Protein Disorders
Boston, Massachusetts, United States
View Trial Details