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Hematological MalignanciesPhase 1/2NCT00379587

Rituximab for Prevention of Chronic GVHD

A Phase 1/2 study testing Rituximab and 375 mg/m2 RRituximab in people with Hematological Malignancies, run by Dana-Farber 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematological Malignancies
What is being tested?
Rituximab and 375 mg/m2 RRituximab
How many people
65 participants
Where
1 siteUnited States
Study dates
Sep 2006to Aug 2012
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation
  • Peripheral blood stem cells must have been used as the stem cell source
  • Patients must have received transplantation from donors who are identical at 6 HLA loci, or mismatched at no more than 1 locus.
  • Patients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment
  • 18 years of age or older
  • Performance Status 0-2
  • Life expectancy of > 100 days
  • Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the bone marrow at the time of study entry

Who cannot join

  • Evidence of relapsed or residual malignancy within 30 days of trial entry
  • Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like lymphoma
  • Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
  • Evidence of any active uncontrolled infection, or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV
  • Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD
  • GVHD with chronic features diagnosed prior to day +100 or prior to enrollment
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  • Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD
  • No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the upcoming 30 days
  • Heart failure uncontrolled by medications
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation

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.

Read the detailed description

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.

Being tested
Rituximab, 375 mg/m2 RRituximab
Keywords
Rituximab, Chronic GVHD
Medical subject headings
Hematologic Neoplasms, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Rituximab at months 3, 6, 9 and 12 post-transplant

  • 375 mg/m2 RRituximabDrug

    Rituximab 375 mg/m2 q3months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years

    Measured: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

Secondary outcomes (3)

  1. Incidence of Grade 3 or Higher Infectious Complications

    Measured: by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

  2. Incidence of Relapse or Progression of Disease

    Percentage of participants with relapsed disease by year 4 post transplant.

    Measured: by 4 years after peripheral blood stem cell (PBSC) infusion

  3. 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.

    Measured: by 18 months after peripheral blood stem (PBSC) infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionAug 2012
  4. Study completionAug 2012

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 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379587
Sponsor's protocol ID
05-377
Status last verified
Feb 2014
First submitted
21 Sep 2006
Last updated
19 Mar 2014

Publications

  • Cutler C, Kim HT, Bindra B, Sarantopoulos S, Ho VT, Chen YB, Rosenblatt J, McDonough S, Watanaboonyongcharoen P, Armand P, Koreth J, Glotzbecker B, Alyea E, Blazar BR, Soiffer RJ, Ritz J, Antin JH. Rituximab prophylaxis prevents corticosteroid-requiring chronic GVHD after allogeneic peripheral blood stem cell transplantation: results of a phase 2 trial. Blood. 2013 Aug 22;122(8):1510-7. doi: 10.1182/blood-2013-04-495895. Epub 2013 Jul 16.

    PubMed 23861248

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab and 375 mg/m2 RRituximab in people with Hematological Malignancies, run by Dana-Farber 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?

The sponsor lists 8 inclusion and 10 exclusion criteria. 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 19 Mar 2014. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2014). 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379587, which also lists 1 linked publication.

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 19 Mar 2014.

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