A Phase 2 interventional study of rituximab and mycophenolate mofetil in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
PRIMARY OBJECTIVES:
I. To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in the conditioning regimen.
SECONDARY OBJECTIVES:
I. To determine the day 100 transplant related mortality after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
II. To determine overall survival (OS) and disease-free survival (DFS) after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
III. To determine the cumulative incidence of infectious complications at day 100 after matched unrelated donor HCT when incorporating rituximab in the conditioning regimen.
IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD) and the cumulative infectious complications at day 100.
V. To determine the effect of rituximab addition to the conditioning regimen on antigen presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1, DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day +30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious complications at day 100.
OUTLINE:
CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients are followed up periodically for 100 days after transplant.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
This study's enrollment of 20 is below the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Compared within Lymphoma, Extranodal NK-T-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia, Myeloid, Accelerated Phase. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Drug: rituximab · Drug: mycophenolate mofetil · Drug: tacrolimus · Drug: anti-thymocyte globulin · Procedure: allogeneic hematopoietic stem cell transplantation · Other: laboratory biomarker analysis · Biological: graft versus host disease prophylaxis/therapy · Drug: cyclophosphamide · Drug: fludarabine phosphate · Drug: busulfan · Radiation: total-body irradiation · Biological: graft-versus-tumor induction therapy · Biological: immunosuppressive therapy
Given IV
Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Given IV or PO
Also known as: Cellcept, MMF
Given IV
Also known as: FK 506, Prograf
Given IV
Also known as: ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin
Stem cell transplant
Correlative studies
Undergo graft versus host disease prophylaxis/therapy
Also known as: prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD
Given PO or IV
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given IV
Also known as: 2-F-ara-AMP, Beneflur, Fludara
Given IV
Also known as: BSF, BU, Misulfan, Mitosan, Myeloleukon
Undergo TBI
Also known as: TBI
Undergo graft-versus-tumor induction therapy
Also known as: graft versus host disease induction, graft versus tumor induction
Undergo immunosuppressive therapy
Also known as: immunosuppression
Number of Participants With Grades II-IV Acute GVHD
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Time frame: At day 100
Event-free Survival
Estimated using Kaplan-Meier estimator.
Time frame: From the date of transplant with relapse/progression or death as censored events, up to 2 years
Overall Survival
Estimated using Kaplan-Meier estimator.
Time frame: From the date of transplant with death from any cause as a censored event, up to 2 years
Transplant-related Mortality (TRM)
Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
Time frame: At day 100
| Milestone | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Ineiligible | 2 |
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
| Participants | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Number of Participants With Grades II-IV Acute GVHD | 16 |
Estimated using Kaplan-Meier estimator.
| months | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Event-free Survival | 12 (6 to 18) |
Estimated using Kaplan-Meier estimator.
| months | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Overall Survival | 12 (9 to 18) |
Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
| Participants | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Transplant-related Mortality (TRM) | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Rituximab and Allogeneic HCT Transplant) | 5/20 (25%) | 10/20 (50%) | 16/20 (80%) |
| Event | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| DiarrheaGastrointestinal disorders | 3/20 |
| pneumonitisInfections and infestations | 3/20 |
| sepsisInfections and infestations | 3/20 |
| acute kidney injuryRenal and urinary disorders | 3/20 |
| cystitisInfections and infestations | 3/20 |
| Immune system disorders-otherImmune system disorders | 2/20 |
| vomitingGastrointestinal disorders | 1/20 |
| anorexiaGastrointestinal disorders | 1/20 |
| mucositis oralGastrointestinal disorders | 1/20 |
| ileusGastrointestinal disorders | 1/20 |
| Event | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| HyperglycemiaMetabolism and nutrition disorders | 8/20 |
| HypokalemiaMetabolism and nutrition disorders | 7/20 |
| HyponatremiaMetabolism and nutrition disorders | 5/20 |
| SepsisInfections and infestations | 5/20 |
| HypophosphatemiaMetabolism and nutrition disorders | 4/20 |
| HypoalbuminemiaMetabolism and nutrition disorders | 4/20 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 3/20 |
| AnorexiaMetabolism and nutrition disorders | 3/20 |
| Mucositis - oralGastrointestinal disorders | 3/20 |
| RashInfections and infestations | 2/20 |
| Age, Continuous(years) | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Median | 39 (21 to 52) |
| Sex: Female, Male(Participants) | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| Female | 11 |
| Male | 9 |
| Region of Enrollment(participants) | Treatment (Rituximab and Allogeneic HCT Transplant) |
|---|---|
| United States | 20 |
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Lymphoma, Extranodal NK-T-Cell →