LeukemiaNCT00534118
Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
A study testing donor lymphocytes in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant. PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic… Read more about this study
- Who is it for?
- Ages Up to 76 years
- Conditions the study is for
- Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- donor lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2003to 26 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Has undergone allogeneic stem cell transplantation (ASCT) for hematologic malignancy at least 30 days ago
- No failure to engraft following transplant
- No active acute or chronic graft-versus-host disease (GVHD)
- Minimal GVHD allowed
- Persistent or relapsed disease after ASCT, including 1 of the following:
- Chronic myelogenous leukemia (CML), meeting any of the following criteria:
- Molecular relapse (may be treated with imatinib mesylate after transplant), as defined by any of the following:
- ASCT was non-T-cell depleted, a negative bcr/abl was documented by PCR post-transplant, and bcr/abl is now detectable by 2 consecutive PCR determinations > 30 days apart
- ASCT was non-T-cell depleted and bcr/abl is detectable by PCR at any time after day 180 post-transplant
- Cytogenetic relapse after 3-6 months of imatinib mesylate
- Relapsed chronic phase, accelerated phase, or blastic phase CML after 3-6 months of imatinib mesylate
- Must currently be in chronic phase or accelerated phase CML only
- Patients with blastic phase CML must attain a second chronic phase
- Acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes, meeting any of the following criteria:
- Molecular relapse, as evidenced by < 5% blasts in the bone marrow and the patient's leukemia-specific molecular abnormality detectable by PCR
- Cytogenetic relapse, as evidenced by < 5% blasts in the bone marrow and the patient's leukemia-specific chromosome abnormality detectable by standard cytogenetics at any time after day 60 post-transplant
- Hematologic relapse, as evidenced by > 20% blasts in bone marrow or soft tissue recurrence
- Must be treated with chemotherapy after transplant, but before study donor lymphocyte infusion (DLI)
- Multiple myeloma
- Relapsed disease or recurrence of M-protein after thalidomide or other salvage treatment
- Prior post-transplant documentation of disappearance of M-protein by immunofixation
- Residual or progressive disease
- Rising M-protein level at any time post-transplant (measured at 3-month intervals)
- Original M-protein detectable at 6 months post-transplant
- Immune protein electrophoresis (IPEP) is required to show that M-component is the same on day 60 post-transplant as pre-transplant
- Residual (> 5%) plasma cells in bone marrow
- Relapsed non-Hodgkin lymphoma or Hodgkin lymphoma
- Relapse or progression of disease must be evidenced within 3 months prior to donor lymphocyte infusion by physical exam, radiographic studies, or molecular studies
- Tumor should be re-biopsied to determine histology
- If Epstein-Barr virus (EBV) lymphoma is suspected, peripheral blood must be assayed for EBV genome (i.e., EBV DNA testing by PCR) within the past 30 days
- EBV infection with associated pancytopenia
- Persistent or refractory pancytopenia with EBV genome detected by PCR in the peripheral blood
- Refractory pancytopenia is defined as pancytopenia that is poorly responsive to growth factors and/or transfusions
- EBV lymphoproliferative disorder
- Clonal lymphadenopathy that is refractory to standard therapy with acyclovir and immunoglobulin (DLI may be given with rituximab)
- Not a candidate for repeat ASCT
- Chimerism status is not required for determining eligibility for DLI
- Patients eligible for allogeneic ASCT, but for whom DLI is offered as the first option, should have full donor chimerism at relapse or after therapy for relapsed disease
- Patients with relapsed underlying disease after transplant who achieved remission after chemotherapy are allowed
- No CNS recurrence that is not cleared by standard chemotherapy
- CNS remission status must be maintained for 2 weeks
- Original hematopoietic progenitor stem cell donor must be available for cell donation
- No syngeneic donors
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 8 weeks
- Creatinine < 3 mg/dL
- ABO/Rh and CMV IgG/IgM status known
- No HIV1 and HIV2 antibody
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months (males) or 6 months (females) after completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant
RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.
PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.
Secondary
- Estimate the complete response rate in these patients.
- Assess the toxicity of donor lymphocyte infusion in these patients.
OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.
- Being tested
- donor lymphocytes
- Keywords
- accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, childhood chronic myelogenous leukemia, previously treated myelodysplastic syndromes, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic-Phase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor lymphocytesBiological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Infusion | Experimental | Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease Receives: Biological: donor lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
continued or induced complete remission after DLI
Measured: 100 days post DLI
Duration of Complete Response in Months (Maximum 12)
For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
Measured: 1 year post DLI
Secondary outcomes (1)
Acute Graft-versus-host Disease
development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Measured: 100 days post DLI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study start1 Oct 2003
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip L. McCarthy, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534118
- Sponsor's protocol ID
- CDR0000564827
- Other IDs
- RPCI-I-00703
- Status last verified
- Aug 2020
- First submitted
- 20 Sep 2007
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00534118
- Acronym / sponsor ID
- CDR0000564827
- Keywords
- accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, childhood chronic myelogenous leukemia, previously treated myelodysplastic syndromes, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.
PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.
Secondary
- Estimate the complete response rate in these patients.
- Assess the toxicity of donor lymphocyte infusion in these patients.
OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion | Experimental | Biological: donor lymphocytesPatients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease |
Who may qualify
- Ages
- Up to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| donor lymphocytesGiven IV | Biological | Infusion |
Primary outcome
Complete Remission Rate
Time frame: 100 days post DLI
continued or induced complete remission after DLI
Duration of Complete Response in Months (Maximum 12)
Time frame: 1 year post DLI
For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
1 secondary outcome
Acute Graft-versus-host Disease
Time frame: 100 days post DLI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip L. McCarthy, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing donor lymphocytes in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 1 site 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 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Remission Rate (time frame: 100 days post DLI). 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 26 Aug 2020.