Clinical trial · Interventional
Donor White Blood Cell Infusions and Interleukin-2 in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed Advanced Lymphoid Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility
- measure
- Toxicity
Secondary outcomes (2)
- measure
- Extent, degree, and duration of donor chimerism
- measure
- Complete response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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 administrationReferences
Publications (0)
Data not yet available