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Lenalidomide and Ipilimumab Post Allo or Auto Stem Cell Transplantation (SCT)

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ClinicalTrials.gov Identifier: NCT01919619
Recruitment Status : Recruiting
First Posted : August 9, 2013
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to study the safety of REVLIMID® (lenalidomide) when given with YERVOY® (ipilimumab) after a stem cell transplant. Researchers also want to find out if lenalidomide given with ipilimumab may help to control leukemia, lymphoma, and multiple myeloma.

Condition or disease Intervention/treatment Phase
Blood And Marrow Transplantation Leukemia Lymphoma Drug: Lenalidomide Drug: Ipilimumab Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Lenalidomide Alternating With Ipilimumab Post Allogeneic and Autologous Stem Cell Transplantation
Actual Study Start Date : November 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lenalidomide + Ipilimumab
Patients receive lenalidomide by mouth alternating with ipilimumab for 4 cycles (lenalidomide for 21 days, then one dose of ipilimumab, then repeat lenalidomide 4 weeks later, etc.) Ipilimumab is fixed at 3 mg/kg and given by vein. One dose of ipilimumab (Cycle 2) given within 1-3 days from the last day of lenalidomide, then followed by 4 weeks of rest. Lenalidomide repeated daily for 21 days (Cycle 3) followed by one dose of ipilimumab (Cycle 4) within 1-3 days from the last dose of lenalidomide. Treatment repeated for a total of 8 cycles.
Drug: Lenalidomide

If creatinine clearance greater than 60 mL/min starting dose of Lenalidomide: 10 mg by mouth daily for 21 days (followed by 7 rest days).

If creatinine clearance 30 to 60 mL/min starting dose of Lenalidomide: 5 mg by mouth daily for 21 days (followed by 7 rest days),

Other Names:
  • CC-5013
  • Revlimid

Drug: Ipilimumab
Ipilimumab 3 mg/kg by vein. One dose of ipilimumab (Cycle 2) given within 1-3 days from the last day of lenalidomide, then followed by 4 weeks of rest. Lenalidomide repeated daily for 21 days (Cycle 3) followed by one dose of ipilimumab (Cycle 4) within 1-3 days from the last dose of lenalidomide. Treatment repeated for a total of 8 cycles.
Other Names:
  • Yervoy
  • BMS-734016
  • MDX010




Primary Outcome Measures :
  1. Toxicity Rate [ Time Frame: 28 days ]
    Each transplant group (either autologous or allogeneic) will be monitored separately for toxicity. Toxicity includes any grade III or IV toxicity requiring a drug hold of more than 2 weeks within the first four cycles that does not resolve with dose reduction or any acute grade III or higher GVHD within 100 days.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >/= 18 years to </= 80 years.
  2. Hematologic or lymphoid malignancy.
  3. Autologous patients can be included anytime within 6 months post-transplant, if they had no signs of progression and meet one of the following criteria: i. Leukemia. ii. Lymphoma (all types of B and T cell lymphoma). ii. Multiple myeloma.
  4. Allogeneic patients if: i. Patients had engrafted donor cells (i.e., > 20% donor T-cell from PB/PCR); and, ii. Patients NOT in CR after their allogeneic transplant, and off tacrolimus and/or mycophenolate mofetil for at least 3 to 4 weeks with no signs of GVHD; or, iii. Patients had evidence of relapse after their transplant who are off tacrolimus and/or mycophenolate mofetil or other immunosuppressants for GVHD for 3 to 4 weeks with no signs of GVHD (Prednisone doses </= 10 mg are permitted as stated previously).
  5. No active infection.
  6. ANC >/= 1.5 x 10^9/L; platelets > 75 x 10^9/L.
  7. Able to adhere to the study visit schedule and other protocol requirements.
  8. Performance status: ECOG 2 or less or Karnofsky of at least 60.
  9. Cardiac EF >/= 45% by 2D-ECHO within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months).
  10. FEV1, FVC and DLCO >/= 40% within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months).
  11. Serum creatinine </= 1.6 mg/dL and creatinine clearance >/= 30 ml/min. Creatinine clearance will be calculated using the Cockcroft-Gault equation: Use actual body weight if it is less than or equal to ideal body weight. Use ideal body weight if patient greater than ideal body weight, but is less than or equal to 50% over ideal body weight. Use adjusted body weight if patient is greater than 50% over ideal body weight.
  12. Liver function tests (unless related to Gilbert's disease or medications) (1) SGPT, SGOT less than 2x the upper limit of normal range. (2) Direct Bilirubin <1.6
  13. Patient or legally authorized representative able to sign informed consent.
  14. 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.

Exclusion Criteria:

  1. Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 4 weeks of first dose.
  2. Patients on alemtuzumab within 6 weeks prior to consenting.
  3. Active congestive heart failure (NYHA Class III to IV), symptomatic ischemia or conduction abnormalities uncontrolled by conventional interventions. Myocardial infarction within 6 months of study entry.
  4. Deep vein thrombosis or pulmonary embolism within 3 months of study entry.
  5. Pregnant or breast-feeding females. (Lactating females must agree not to breast-feed while taking lenalidomide).
  6. Acute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first dose.
  7. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B Sag or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
  8. Patients with other known malignancies within the past three years except: i. Adequately treated basal or squamous cell skin cancer. ii. Carcinoma in situ of the cervix. iii. Prostate cancer with Gleason score < 6 with stable PSA over the past three months. iv. Breast cancer in situ with full surgical resection.
  9. Significant neuropathy (grades 3 to 4 or grade 2 pain).
  10. Known hypersensitivity to thalidomide, lenalidomide or ipilimumab.
  11. Active life-threatening autoimmune disease.
  12. Active GVHD or recent GVHD and still on > 10 mg prednisone (or equivalent).
  13. Prior auto-immune disease.

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): NCT01919619


Contacts
Contact: Issa F. Khouri, MD, BS 713-792-8750 ikhouri@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       ikhouri@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Issa F. Khouri, MD, BS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01919619     History of Changes
Other Study ID Numbers: 2012-0947
NCI-2013-02213 ( Registry Identifier: NCI CTRP )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 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:
Blood And Marrow Transplantation
Leukemia
Lymphoma
Allogeneic stem cell transplant
Autologous stem cell transplant
SCT
Lenalidomide CC-5013
Revlimid
Ipilimumab
Yervoy
BMS-734016
MDX010

Additional relevant MeSH terms:
Lenalidomide
Thalidomide
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents