An interventional study of donor lymphocytes in Leukemia, Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged Up to 76 Years. Per ClinicalTrials.gov, last updated 2020-08-26.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.
This study's enrollment of 39 is close to the median of 40 across 1,769 interventional studies indexed under Leukemia.
Browse Leukemia studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Has undergone stem cell transplantation (ASCT) for hematologic at least 30 days ago
No active acute or chronic (GVHD)
Persistent or 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:
Relapsed chronic phase, accelerated phase, or blastic phase CML after 3-6 months of imatinib mesylate
Acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes, meeting any of the following criteria:
Hematologic relapse, as evidenced by > 20% blasts in bone marrow or soft tissue recurrence
Multiple myeloma
Relapsed disease or recurrence of M-protein after thalidomide or other salvage treatment
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
EBV infection with associated pancytopenia
Persistent or refractory pancytopenia with EBV genome detected by PCR in the peripheral blood
EBV lymphoproliferative disorder
Not a candidate for repeat ASCT
No CNS recurrence that is not cleared by standard chemotherapy
Original hematopoietic progenitor stem cell donor must be available for cell donation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: donor lymphocytes
Given IV
Complete Remission Rate
continued or induced complete remission after DLI
Time frame: 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)
Time frame: 1 year post DLI
Acute Graft-versus-host Disease
development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
Time frame: 100 days post DLI
| Milestone | Multiple DLI | Single DLI |
|---|---|---|
| Started | 17 | 22 |
| Completed | 17 | 22 |
| Not completed | 0 | 0 |
continued or induced complete remission after DLI
| Participants | Multiple DLI | Single DLI |
|---|---|---|
| Complete Remission Rate | 8 | 6 |
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)
| months | Multiple DLI - Complete Responders | Single DLI - Complete Responders |
|---|---|---|
| Duration of Complete Response in Months (Maximum 12) | 10.1 (1.7 to 12) | 9 (1.0 to 12) |
development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
| Participants | Multiple DLI | Single DLI |
|---|---|---|
| Acute Graft-versus-host Disease | 0 | 4 |
Collected over All cause mortality includes individual participants who experienced death due to any cause before 3 years after first DLI and is the only SAE/AE captured per protocol. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multiple DLI | 10/15 (66.7%) | 10/15 (66.7%) | 0/15 (0%) |
| Single DLI | 7/12 (58.3%) | 7/12 (58.3%) | 0/12 (0%) |
| Event | Multiple DLI | Single DLI |
|---|---|---|
| All cause mortality by 3 years after first DLIGeneral disorders | 10/15 | 7/12 |
Participants can be accrued more than once; Accruals are based on the number of times the participant had a treatment (DLI) cycle that was evaluable (ie. \>8 weeks between infusions per the protocol). DLIs which were given \<8 weeks apart counted as one accrual.
| Age, Categorical(Participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| <=18 years | 1 | 1 | 2 |
| Between 18 and 65 years | 12 | 9 | 21 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| Median | 45 (16 to 66) | 53.5 (9 to 68) | 51 (9 to 68) |
| Sex: Female, Male(Participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 12 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 12 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| United States | 15 | 12 | 27 |
| Disease(Participants) | Multiple DLI | Single DLI | Total |
|---|---|---|---|
| Acute Myeloid Leukemia | 8 | 9 | 17 |
| Myelodysplastic Syndrome | 2 | 0 | 2 |
| Non Hodgkin Leukemia | 2 | 1 | 3 |
| Acute Lymphoblastic Leukemia | 1 | 0 | 1 |
| Chronic Myeloid Leukemia | 1 | 1 | 2 |
| Hodgkin Lymphoma | 1 | 0 | 1 |
| Prolymphocytic Leukemia | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2003 to primary completion in Jul 2018, 177 months.
Results were first posted in Aug 2020, 2 years 1 month after primary completion.
Of 103 non-industry interventional studies with no phase under Leukemia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 128. This study's 177 months is above that.
Counting every sponsor, half of 110 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donor Lymphocytes
Roswell Park Cancer Institute →