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Fludarabine, Bendamustine and Rituximab Conditioning for Patients With Lymphoid Malignancies

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ClinicalTrials.gov Identifier: NCT00880815
Recruitment Status : Active, not recruiting
First Posted : April 14, 2009
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if bendamustine, when given with a stem cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem cells start to grow and make new blood cells in patients with leukemia and lymphoma. The safety of this combination will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: Bendamustine Drug: Rituximab Drug: Fludarabine Procedure: Stem Cell Transplant (SCT) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies
Actual Study Start Date : February 2009
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Bendamustine + Chemotherapy + SCT
Bendamustine starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3. Rituximab dose of 375 mg/m^2 by vein over 5-7 hours on Day -13 and 1000 mg/m^2 on Day -6, Day +1 and Day +8 (1 time each week for four weeks). Fludarabine 30 mg/m^2 on Day -5 to Day -3. Infusion of donor blood stem cells - Stem Cell Transplant (SCT) - by vein over 30-45 minutes on Day 0.
Drug: Bendamustine
Starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3.
Other Names:
  • Bendamustine HCI
  • Bendamustine Hydrochloride
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Rituximab
Dose of 375 mg/m^2 by vein over 5-7 hours on Day -13 and 1000 mg/m^2 on Day -6, Day +1 and Day +8 (1 time each week for four weeks).
Other Name: Rituxan
Drug: Fludarabine
30 mg/m^2 on Day -5 to Day -3.
Other Names:
  • Fludara
  • Fludarabine Phosphate
Procedure: Stem Cell Transplant (SCT)
Infusion of donor blood stem cells by vein over 30-45 minutes on Day 0.
Other Names:
  • Stem Cell Infusion
  • Allogenic Stem Cell Transplant

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Bendamustine [ Time Frame: Continual reassessment during first 30 days for dose limiting toxicity (DLT) ]
    MTD defined as dose with posterior mean Pr{DLT} closest to 0.30 at the end of the trial, provided that it is not terminated early.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 to 70 years of age.
  2. Patients with cluster of differentiation antigen 20 (CD20) + CLL, marginal zone, mantle cell and follicular lymphoma or T-cell lymphoid malignancies who are eligible for allogeneic transplantation.
  3. Patients with relapsed diffuse large B-cell lymphoma may be included if there were not eligible for autologous transplantation.
  4. A fully-matched sibling donor or matched unrelated donor.
  5. Left ventricular EF > 40% with no uncontrolled arrythmias or symptomatic heart disease.
  6. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) > 40%.
  7. Serum creatinine < 1.6 mg/dL. Serum bilirubin < 3X upper limit of normal.
  8. Serum glutamate pyruvate transaminase (SGPT) < 3X upper limit of normal.
  9. 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.
  10. 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.

Exclusion Criteria:

  1. Patient with active central nervous system (CNS) disease.
  2. 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.
  3. Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
  4. Patients with other malignancies diagnosed within 2 years prior to Study Day-13 (except skin squamous or basal cell carcinoma).
  5. Active uncontrolled bacterial, viral or fungal infections.
  6. History of Stroke within 6 months.
  7. 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 arrythmias, unstable angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by investigator as not medically relevant.
  8. A prior allogeneic transplant.
  9. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  10. Patient has received other investigational drugs within 3 weeks before enrollment.
  11. Hypersensitivity to bendamustine.
  12. Prior known refractoriness to bendamustine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880815

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Issa F. Khouri, MD, BS M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00880815     History of Changes
Other Study ID Numbers: 2008-0246
NCI-2010-01034 ( Registry Identifier: NCI CTRP )
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lymphoid Malignancies
Non-myeloablative Allogeneic Conditioning
Non-myeloablative Allogeneic Hematopoietic Transplantation
Stem Cell Transplant
Bendamustine HCI
Bendamustine Hydrochloride
Fludarabine Phosphate
Graft-versus-host disease

Additional relevant MeSH terms:
Fludarabine phosphate
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents