A Phase 1/2 interventional study of Rituximab and 375 mg/m2 RRituximab in Hematological Malignancies, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-19.
Sponsored by Dana-Farber Cancer Institute · Phase 1/2, Interventional, and Prevention
The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to "reject" the body. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them.
Study Design: The study is designed as a Phase II, open label trial of Rituximab as chronic GVHD prophylaxis after HLA-matched, related or unrelated peripheral blood stem cell transplantation after ablative or non-ablative conditioning.
Primary Objective: To determine the incidence of clinically extensive chronic GVHD at one and two years after allogeneic stem cell transplantation after a single dose of Rituximab administered at 100 days, 6 months, 9 months and 1 year from transplantation as chronic GVHD prophylaxis.
Secondary Objectives: To determine the incidence of adverse hematological events, the incidence of infectious complications, the rate of malignant relapse, and the effects on donor hematopoietic chimerism after Rituximab administration.
Eligibility Criteria: Eligible patients will be 18 years of age or greater and will have undergone a non-myeloablative or fully ablative transplantation from an HLA-matched (6/6 loci) or single antigen/allele mismatched (5/6) donor approximately 100 days ago. Adequate performance status and organ function will be confirmed prior to enrollment. No ongoing infection or acute GVHD will be present at the time of enrollment. Evidence of sustained donor chimerism will be confirmed prior to study entry.
Treatment Description: Chronic GVHD prophylaxis will consist of Rituximab 375 mg/m2 administered 100 days, 6, 9 and 12 months after transplantation.
Accrual Objective: 68 patients will be accrued over 12 months.
Study Duration: Patients will be evaluated for two years after the time of transplantation for evaluation of the primary and secondary endpoints. Subjects will be followed longitudinally after completion of the study period for determination of clinical status.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 65 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
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Exclusion Criteria:
Rituximab at months 3, 6, 9 and 12 post-transplant
Rituximab 375 mg/m2 q3months
Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years
Time frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
Incidence of Grade 3 or Higher Infectious Complications
Time frame: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
Incidence of Relapse or Progression of Disease
Percentage of participants with relapsed disease by year 4 post transplant.
Time frame: by 4 years after peripheral blood stem cell (PBSC) infusion
Incidence of Adverse Hematological Events
White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.
Time frame: by 18 months after peripheral blood stem (PBSC) infusion
| Milestone | Rituxan (Rituximab) |
|---|---|
| Started | 65 |
| Completed | 63 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
| percentage of participants | Rituxan (Rituximab) |
|---|---|
| Year One | 38 |
| Year Two | 48 |
| percentage of participants | Rituxan (Rituximab) |
|---|---|
| Year One | 11 |
| Year Two | 15 |
Percentage of participants with relapsed disease by year 4 post transplant.
| percentage of participants | Rituxan (Rituximab) |
|---|---|
| Incidence of Relapse or Progression of Disease | 34 |
White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.
| participants | Rituxan (Rituximab) |
|---|---|
| Incidence of Adverse Hematological Events | 11 |
Collected over Reported Adverse Events (AEs) inlcude events starting on or after day 0 and on or before day 540.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituxan (Rituximab) | — | 6/65 (9.2%) | 22/65 (33.8%) |
| Event | Rituxan (Rituximab) |
|---|---|
| PneumoniaInfections and infestations | 2/65 |
| Septic ShockInfections and infestations | 1/65 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/65 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/65 |
| Interstital PneumonitisRespiratory, thoracic and mediastinal disorders | 1/65 |
| Event | Rituxan (Rituximab) |
|---|---|
| Neutrophil DecreaseBlood and lymphatic system disorders | 7/65 |
| Alanine Aminotransferase IncreaseBlood and lymphatic system disorders | 6/65 |
| Aspartate Aminotransferase IncreaseBlood and lymphatic system disorders | 6/65 |
| FatigueGeneral disorders | 5/65 |
| Hemoglobin DecreaseBlood and lymphatic system disorders | 4/65 |
| Platelet DecreaseBlood and lymphatic system disorders | 4/65 |
| Rash/DesquamationSkin and subcutaneous tissue disorders | 4/65 |
| MucositisGastrointestinal disorders | 4/65 |
| Alkaline Phosphatase IncreaseBlood and lymphatic system disorders | 4/65 |
| Age, Categorical(Participants) | Rituxan (Rituximab) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 54 |
| >=65 years | 11 |
| Age, Continuous(years) | Rituxan (Rituximab) |
|---|---|
| Median | 54 (19 to 74) |
| Sex: Female, Male(Participants) | Rituxan (Rituximab) |
|---|---|
| Female | 26 |
| Male | 39 |
| Region of Enrollment(participants) | Rituxan (Rituximab) |
|---|---|
| United States | 65 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute