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CD20 PositivePhase 1NCT00880815

Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant

A Phase 1 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin and Bendamustine in people with CD20 Positive and Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center 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

This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin and Bendamustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
17 Feb 2009to 28 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with CD20 + chronic lymphocytic leukemia (CLL), marginal zone, mantle cell and follicular lymphoma or T-cell lymphoid malignancies who are eligible for allogeneic transplantation.
  • Patients with relapsed diffuse large B-cell lymphoma may be included if they were not eligible for autologous transplantation.
  • A fully-matched sibling donor or matched unrelated donor.
  • Left ventricular ejection fraction (EF) > 40% with no uncontrolled arrhythmias or symptomatic heart disease.
  • Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) > 40%.
  • Serum creatinine < 1.6 mg/dL.
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  • Serum bilirubin < 3 X upper limit of normal.
  • Serum glutamate pyruvate transaminase (SGPT) < 3 X upper limit of normal.
  • Voluntary signed, written Institutional Review Board (IRB)-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.

Who cannot join

  • Patient with active central nervous system (CNS) disease.
  • Pregnant (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • Known infection with human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV)-I, hepatitis B, or hepatitis C.
  • Patients with other malignancies diagnosed within 2 years prior to study day-13 (except skin squamous or basal cell carcinoma).
  • Active uncontrolled bacterial, viral or fungal infections.
  • History of stroke within 6 months.
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  • Myocardial infarction within the past 6 months prior to study day 1, or has New York Heart Association (NYHA) class III or IV heart failure or arrhythmias, unstable angina, uncontrolled congestive heart failure or arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiography (ECG) abnormality at screening must be documented by investigator as not medically relevant.
  • A prior allogeneic transplant.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Patient has received other investigational drugs within 3 weeks before enrollment.
  • Hypersensitivity to bendamustine.
  • Prior known refractoriness to bendamustine.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Fludarabine, Bendamustine, and Rituximab (FBR) Non-Myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies

This phase I trial studies the best dose and how well bendamustine works with standard chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine, bendamustine, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes, the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving rituximab and methotrexate after the transplant may stop this from happening.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine engraftment and dose limiting toxicity (DLT) of bendamustine in patients with lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.

SECONDARY OBJECTIVES:

  1. To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.

OUTLINE: This is a dose escalation study of bendamustine.

Participants receive rituximab intravenously (IV) over 5-7 hours on days -13 and -6, fludarabine IV over 1 hour and bendamustine IV over 1 hour on days -5 to -3, and tacrolimus IV starting on day -2 and orally (PO) after hospital discharge for 6 to 8 months. Participants with matched unrelated donor (MUD) receive thymoglobulin on days -2 and -1. Participants undergo allogenic stem cell transplant over 30-45 minutes on day 0. Participants receive rituximab IV over 5-7 hours on days 1 and 8 and methotrexate IV over 30 minutes on days 1, 3, and 6. Participants with MUD also receive methotrexate IV on day 11. Participants receive filgrastim (G-CSF) subcutaneously (SC) once daily starting on day 7 until white blood cell counts recover.

After completion of study treatment, participants are followed up every 3 months during year 1 and every 6 months for up to 3 years.

Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell

What participants receive

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

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT

    Undergo ASCT

  • Anti-Thymocyte GlobulinBiological

    Also called Antithymocyte Globulin, Antithymocyte Serum, ATG, ATGAM

    Given IV

  • BendamustineDrug

    Also called SDX-105

    Given IV

  • FilgrastimBiological

    Also called FILGRASTIM, LICENSE HOLDER UNSPECIFIED, G-CSF, Neupogen, r-metHuG-CSF

    Given IV

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • MethotrexateDrug

    Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate

    Given IV

  • RituximabBiological

    Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody

    Given IV

  • TacrolimusDrug

    Also called FK 506, Fujimycin, Hecoria, Prograf

    Given IV and PO

Study groups in NCT00880815
Study groupRoleWhat they receive
Treatment (chemotherapy, stem cell transplant, rituximab)ExperimentalParticipants receive rituximab IV over 5-7 hours on days -13 and -6, fludarabine IV over 1 hour and bendamustine IV over 1 hour on days -5 to -3, and tacrolimus IV starting on day -2 and PO after hospital discharge for 6 to 8 months. Participants with MUD receive thymoglobulin on days -2 and -1. Participants undergo allogenic stem cell transplant over 30-45 minutes on day 0. Participants receive rituximab IV over 5-7 hours on days 1 and 8 and methotrexate IV over 30 minutes on days 1, 3, and 6. Participants with MUD also receive methotrexate IV on day 11. Participants receive G-CSF SC once daily starting on day 7 until white blood cell counts recover.
Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Biological: Anti-Thymocyte Globulin; Drug: Bendamustine; Biological: Filgrastim; Drug: Fludarabine; Drug: Methotrexate; Biological: Rituximab; Drug: Tacrolimus

What is being measured

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

  1. Maximum tolerated dose of bendamustine

    Measured: Up to 30 days

Timeline

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

  1. First posted14 Apr 2009 (estimated)
  2. Study start17 Feb 2009
  3. Primary completion28 May 2019
  4. Study completion28 May 2019

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880815
Sponsor's protocol ID
2008-0246
Other IDs
NCI-2018-01844, 2008-0246, P30CA016672
Status last verified
May 2019
First submitted
13 Apr 2009
Last updated
3 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khouri IF, Wei W, Korbling M, Turturro F, Ahmed S, Alousi A, Anderlini P, Ciurea S, Jabbour E, Oran B, Popat UR, Rondon G, Bassett RL Jr, Gulbis A. BFR (bendamustine, fludarabine, and rituximab) allogeneic conditioning for chronic lymphocytic leukemia/lymphoma: reduced myelosuppression and GVHD. Blood. 2014 Oct 2;124(14):2306-12. doi: 10.1182/blood-2014-07-587519. Epub 2014 Aug 21.

    PubMed 25145344

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin and Bendamustine in people with CD20 Positive and Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center 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 10 inclusion and 12 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 3 Jun 2019. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of bendamustine (time frame: Up to 30 days). 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 NCT00880815, 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 3 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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