A Phase 2 interventional study of anti-thymocyte globulin and rituximab in Chronic Myeloproliferative Disorders, Graft Versus Host Disease and Leukemia, sponsored by Barbara Ann Karmanos Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 2, Interventional, and Supportive care
This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive rituximab IV on days -7 and 3, tacrolimus IV continuously (may switch to orally when the patient is able to eat) and oral sirolimus beginning on day -3, and anti-thymocyte globulin IV over 6 hours on days -3 to -1. Tacrolimus and sirolimus are tapered at the discretion of the treating physician.
All patients also receive a standard transplant-preparative regimen and undergo transplantation on day 0.
Blood samples are collected before the preparative regimen and at 30, 60, 90, and 180 days after transplantation for correlative immunologic studies.
After completion of study treatment, patients are followed up for 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 4 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of a hematological malignancy, including:
Available suitable haploidentical or partial-matched unrelated donor (high-resolution molecular HLA typing is mandatory for HLA Class I and II)
Scheduled to undergo peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
Biological: anti-thymocyte globulin · Biological: rituximab · Drug: sirolimus · Drug: tacrolimus · Other: laboratory biomarker analysis · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: management of therapy complications · Procedure: peripheral blood stem cell transplantation
Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.
The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; if there is no reaction, increase the rate by 50 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Subsequent infusions: If patient did not tolerate initial infusion follow initial infusion guidelines. If patient tolerated initial infusion, start at 100 mg/hour; if there is no reaction, increase the rate by 100 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Note: If a reaction occurs, slow or stop the infusion. If the reaction abates, restart infusion at 50% of the previous rate. In patients who tolerated the Rituximab well in the past, a rapid infusion rate can be used over 90 minutes with 20% of the dose administered in the first 30 minutes and the remaining 80% is given over 60 minutes.
Also known as: Rituxan®
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Also known as: Rapamune®
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
Also known as: Prograf
laboratory biomarker analysis
allogeneic hematopoietic stem cell transplantation
management of therapy complications
peripheral blood stem cell transplantation
Incidence and Severity of Acute Graft-vs-host Disease (GVHD)
Time frame: During the first six months post transplant
Time to Engraftment
Time frame: During the first six months post transplant
Safety Assessment
Time frame: During the first six months post transplant
Incidence of Chronic GVHD
Time frame: Within two years after transplant
Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder
Time frame: At one year
Incidence of Thrombotic Microangiopathy
Time frame: Within 100 days of HCT
Overall and Disease-free Survival
Time frame: At 1 year
Immunocorrelative Studies Pre- and Periodically Post-transplantation
Time frame: Using flow cytometry at 30, 60, 90, and 180 days post transplant.
Cancer center clinic.
| Milestone | Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Progressive diease | 4 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Age, Continuous(years) | Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, |
|---|---|
| Mean | 50 ± 2.82 |
| Sex: Female, Male(Participants) | Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, |
|---|---|
| Female | 2 |
| Male | 2 |
| Region of Enrollment(participants) | Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus, |
|---|---|
| United States | 4 |
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barbara Ann Karmanos Cancer Institute