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Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00899431
Recruitment Status : Terminated (Terminated per PI's request at the time of continuing review)
First Posted : May 12, 2009
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Lenalidomide Drug: Fludarabine Drug: Rituximab Drug: Thymoglobulin Procedure: Stem Cell Transplantation Drug: Bendamustine Drug: Allopurinol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonmyeloablative Stem Cell Transplantation With or Without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294)
Actual Study Start Date : May 6, 2009
Actual Primary Completion Date : October 7, 2018
Actual Study Completion Date : October 7, 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Immunomanipulation After Non-myeloablative Stem Cell Transplantation for CLL (Chronic Lymphocytic Leukemia). [ Time Frame: Up to 18 months after allotransplant. ]
    To compare the need for immunomanipulation within 18 months after non-myeloablative allogeneic transplantation for CLL between the two combination therapies with or without lenalidomide maintenance. For this purpose, "immunomanipulation" is defined as any one of the following events: 1) Cessation of administering tacrolimus treatment with in the first 6 months after allotransplant due to persistent disease or progression. 2) Boost of donor lymphocytic infusion (DLI) administered anytime between 3 and 18 months after allotransplant.


Secondary Outcome Measures :
  1. Percentage of Participants With GVHD (Graft Versus Host Disease) [ Time Frame: Up to 6 months after allotransplant ]
    Acute grade 2 to 4 Graft versus host disease( GVHD )for patients who were able to be analyzed by measuring the T cell counts for increased CD3+ before and after lenalidomide.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT00899431


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
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Study Chair: Issa F. Khouri, MD, BS M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00899431    
Other Study ID Numbers: 2007-0871
NCI-2012-01620 ( Registry Identifier: NCI CTRP )
First Posted: May 12, 2009    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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:
Nonmyeloablative Stem Cell Transplantation
Chronic Lymphocytic Leukemia
CLL
Immunomanipulation
Fludarabine
Lenalidomide
Rituximab
Thymoglobulin
Stem Cell Transplantation
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lenalidomide
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vidarabine
Rituximab
Fludarabine
Fludarabine phosphate
Bendamustine Hydrochloride
Allopurinol
Thymoglobulin
Antilymphocyte Serum
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents