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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00534118
Study groupRoleWhat they receive
InfusionExperimentalPatients 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.

  1. Complete Remission Rate

    continued or induced complete remission after DLI

    Measured: 100 days post DLI

  2. 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)
  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.

  1. First posted24 Sep 2007 (estimated)
  2. Study start1 Oct 2003
  3. Primary completion26 Jul 2018
  4. Study completion26 Jul 2018

Resources

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)
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
Data monitoring committee
Yes

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.

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Clinical Trial NCT00534118 | AzTrials