Fludarabine, Bendamustine and Rituximab Conditioning for Patients With Lymphoid Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00880815
First received: April 13, 2009
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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
Leukemia
Lymphoma
Drug: Bendamustine
Drug: Rituximab
Drug: Fludarabine
Procedure: Stem Cell Transplant (SCT)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Primary Completion Date: April 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 70 years of age.
  2. Patients with 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. FEV1, FVC and DLCO > 40%.
  7. Serum creatinine < 1.6 mg/dL. Serum bilirubin < 3X upper limit of normal.
  8. SGPT < 3X upper limit of normal.
  9. Voluntary signed, written 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 CNS disease.
  2. Pregnant (Positive Beta 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880815

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Principal Investigator: Issa F. Khouri, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00880815     History of Changes
Other Study ID Numbers: 2008-0246
Study First Received: April 13, 2009
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lymphoma
Lymphoid Malignancies
Non-myeloablative Allogeneic Conditioning
Non-myeloablative Allogeneic Hematopoietic Transplantation
Stem Cell Transplant
SCT
Bendamustine HCI
Bendamustine
Bendamustine Hydrochloride
CEP-18083
SDX-105
Treanda
Fludarabine
Fludarabine Phosphate
Fludara
Rituximab
Rituxan
FBR
Graft-versus-host disease
GVHD

Additional relevant MeSH terms:
Neoplasms
Leukemia
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014