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Fludarabine, Bendamustine and Rituximab Conditioning for Patients With Lymphoid Malignancies

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: April 13, 2009
Last updated: October 5, 2015
Last verified: October 2015
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 Intervention Phase
Drug: Bendamustine
Drug: Rituximab
Drug: Fludarabine
Procedure: Stem Cell Transplant (SCT)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.

Enrollment: 60
Study Start Date: February 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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.
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00880815     History of Changes
Other Study ID Numbers: 2008-0246
NCI-2010-01034 ( Registry Identifier: NCI CTRP )
Study First Received: April 13, 2009
Last Updated: October 5, 2015

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 processed this record on May 23, 2017