Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00899431
First received: May 8, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Lenalidomide
Drug: Fludarabine
Drug: Rituximab
Drug: Thymoglobulin
Procedure: Stem Cell Transplantation
Drug: Bendamustine
Drug: Allopurinol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonmyeloablative Stem Cell Transplantation With or Without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients Needing Immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL with or without lenalidomide maintenance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: Lenalidomide
Chemotherapy, Plus Lenalidomide - Lenalidomide starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months. Fludarabine 30 mg/m^2 intravenously daily on days -5, -4, -3. Rituximab 375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8. Thymoglobulin 1.0 mg/kg intravenously over 4 hours (day -2 and -1). On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes. Bendamustine 130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine). Allopurinol 300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.
Drug: Lenalidomide
Starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months
Other Names:
  • CC-5013
  • Revlimid
Drug: Fludarabine
30 mg/m^2 intravenously daily on days -5, -4, -3.
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Rituximab
375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8.
Other Name: Rituxan
Drug: Thymoglobulin
1.0 mg/kg intravenously over 4 hours (day -2 and -1).
Other Names:
  • ATG
  • rabbit anti-thymocyte globulin
Procedure: Stem Cell Transplantation
On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
Other Names:
  • SCT
  • Nonmyeloablative Stem Cell Transplantation
Drug: Bendamustine
130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
Other Names:
  • Bendamustine Hydrochloride
  • Bendamustine HCL
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Allopurinol
300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.
Other Names:
  • Lopurin
  • Zurinol
  • Zyloprim
Active Comparator: Group 2: No Lenalidomide
Chemotherapy Treatment, No Lenalidomide - Fludarabine 30 mg/m^2 intravenously daily on days -5, -4, -3. Rituximab 375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8. Thymoglobulin 1.0 mg/kg intravenously over 4 hours (day -2 and -1). On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes. Bendamustine 130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
Drug: Fludarabine
30 mg/m^2 intravenously daily on days -5, -4, -3.
Other Names:
  • Fludara
  • Fludarabine Phosphate
Drug: Rituximab
375 mg/m2 intravenously on day -13, and 1000 mg/m^2 on days -6, +1 and +8.
Other Name: Rituxan
Drug: Thymoglobulin
1.0 mg/kg intravenously over 4 hours (day -2 and -1).
Other Names:
  • ATG
  • rabbit anti-thymocyte globulin
Procedure: Stem Cell Transplantation
On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
Other Names:
  • SCT
  • Nonmyeloablative Stem Cell Transplantation
Drug: Bendamustine
130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
Other Names:
  • Bendamustine Hydrochloride
  • Bendamustine HCL
  • CEP-18083
  • SDX-105
  • Treanda

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years at the time of signing the informed consent form.
  2. Disease: CLL in relapse, after failing conventional chemo-antibody combination therapy; CLL patients who failed to achieve CR with frontline conventional chemo-antibody; CLL patients with 17p deletion; CLL in Richter's.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Donor: HLA compatible related (HLA-A,-B,-DRBI matched or with one-antigen mismatched) or HLA compatible unrelated.
  5. ECOG performance status of </= 2 at study entry
  6. FEV1, FVC and DLCO >/= 40%.
  7. Left ventricular EF > 40% with no uncontrolled arrhythmias or symptomatic heart disease.
  8. Serum creatinine </= 1.6 mg/dL. Serum bilirubin < 1.6 mg/dL.
  9. SGPT < 2x upper limit of normal.
  10. 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.
  11. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 3 weeks prior to treatment in this study.
  12. Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
  13. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to study entry.
  14. Disease must be chemosensitive (ie, patients must have PR or better based on CT Scans, PET Scan, and bone marrow biopsy).
  15. Patients suspected to have Richter's transformation (such as elevated LDH) and/or who are PET positive, should have a lymph node biopsy to assess histological status of the disease
  16. Patients must be off of alemtuzumab for 6 weeks prior to consenting.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  4. Use of any other experimental drug or therapy within 28 days of baseline.
  5. Known hypersensitivity to thalidomide, lenalidomide, bendamustine, fludarabine. For patients will unrelated donors: Known hypersensitivity to thymoglobulin.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Concurrent use of other anti-cancer agents or treatments.
  8. Known positive for HIV or infectious hepatitis, type A, B or C.
  9. Sinuses should be evaluated by either CT neck or CT sinuses to exclude infections
  10. Deep-vein thrombosis or pulmonary embolism within 3 months of study entry.
  11. History of serious infection requiring hospitalization within the last 3 months of consenting.
  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: NCT00899431

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Study Chair: 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: NCT00899431     History of Changes
Other Study ID Numbers: 2007-0871, NCI-2012-01620
Study First Received: May 8, 2009
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Nonmyeloablative Stem Cell Transplantation
Chronic Lymphocytic Leukemia
CLL
Immunomanipulation
Fludarabine
Lenalidomide
Rituximab
Thymoglobulin
Stem Cell Transplantation

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Bendamustine
Lenalidomide
Fludarabine
Fludarabine phosphate
Nitrogen Mustard Compounds
Thalidomide
Antilymphocyte Serum
Allopurinol
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014