Graft Versus Host DiseasePhase 1/2NCT00248430
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 1/2 study testing aldesleukin, therapeutic allogeneic lymphocytes and melphalan in people with Graft Versus Host Disease and Leukemia, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Graft Versus Host Disease, Leukemia, Lymphoma
- What is being tested?
- aldesleukin, therapeutic allogeneic lymphocytes and melphalan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2003to Jul 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- aldesleukin, therapeutic allogeneic lymphocytes, melphalan, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
- Keywords
- graft versus host disease, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, recurrent mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma
- Medical subject headings
- Graft vs Host Disease, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
therapeutic allogeneic lymphocytesBiological
melphalanDrug
bone marrow ablation with stem cell supportProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Toxicity
Secondary outcomes (2)
Extent, degree, and duration of donor chimerism
Complete response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startAug 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- William I. Bensinger, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248430
- Sponsor's protocol ID
- 1838.00
- Other IDs
- FHCRC-1838.00, CDR0000430694
- Status last verified
- Sep 2010
- First submitted
- 3 Nov 2005
- Last updated
- 21 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00248430
- Acronym / sponsor ID
- 1838.00
- Keywords
- graft versus host disease, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent small lymphocytic lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| therapeutic allogeneic lymphocytes | Biological | – |
| melphalan | Drug | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Feasibility
Toxicity
2 secondary outcomes
Extent, degree, and duration of donor chimerism
Complete response rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William I. Bensinger, MD principal investigator
Fred Hutchinson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aldesleukin, therapeutic allogeneic lymphocytes and melphalan in people with Graft Versus Host Disease and Leukemia, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010.